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Spine

SI-BONE’s New iFuse-Navigation™ Set* and iFuse-3D™ Fenestrated SI Joint Fusion Implant to be Featured at NASS 2017

October 23, 2017 OrthoSpineNews

SAN JOSE, Calif., Oct. 23, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced its new iFuse-Navigation Set* and proprietary 3D printed iFuse-3D fenestrated triangular titanium implant, will be featured at this year’s North American Spine Society (NASS) annual meeting in Orlando, FL.  The new iFuse-Navigation Set was designed to allow surgeons using the O-armTMimaging system and StealthStationTM navigation system to perform the iFuse procedure for MIS SI joint fusion.

In addition to the new iFuse-Navigation Set, the company will also showcase its new iFuse-3D Implant. This novel implant combines the patented triangular shape of the iFuse ImplantTM with a proprietary 3D-printed porous trabecular surface and unique patented fenestrated design which is intended to enhance bony ongrowth, ingrowth, through growth and intra-articular fusion.

The company will also be hosting Dr. David Polly**, Chief of Spine Surgery at the University of Minnesota, on Thursday, October 26th from 3:10 pm to 3:40 pm at its booth (#1518) in the NASS exhibit hall.  Dr. Polly will present and discuss his experience utilizing navigation with the iFuse Procedure as well as his clinical experience with the new iFuse-3D Implant.

“We are excited to have Dr. Polly join us at our booth and we’re grateful that he has offered to take time to share his clinical experience with the iFuse Implant System® and navigation as well as provide his initial perspective on the new iFuse-3D Implant,” said Tony Recupero, Chief Commercial Officer at SI-BONE.  “We have made great progress this past year toward advancing the diagnosis and treatment of SI joint disorders and we look forward to this year’s NASS meeting to help build on that progress and create even greater awareness about the condition and access to our procedure.”

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs.  Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes.  Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions.  The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution.  The iFuse ImplantTM was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with sacroiliac joint dysfunction experience pain that can be debilitating.  SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

*Pending 510(k), not available for sale in USA.
**Dr. Polly was an investigator on a clinical research study sponsored by SI-BONE. He has no financial interest in SI-BONE.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. iFuse-Navigation and iFuse-3D are trademarks of SI-BONE, Inc.  ©2017 SI-BONE, Inc. All Rights Reserved.  All other trademarks are property of their respective owners.

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  1. Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
  2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

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SpineTop Stories

NuVasive Extends Its Leadership As Lateral Spine Technology Innovator With New Lateral Single-Position Surgery Procedure

October 23, 2017 OrthoSpineNews

SAN DIEGO, Oct. 23, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced new lateral solutions that enable surgeons to perform lateral single-position surgery and expand the Company’s comprehensive lateral portfolio.

Nearly 15 years ago, NuVasive revolutionized spine surgery through the development of XLIF®, the only lateral approach spine procedure proven with extensive clinical evidence and more than 400 peer-reviewed, XLIF-specific publications. NuVasive continues to innovate the XLIF procedure today by introducing lateral single-position approach to surgery and thereby increasing O.R. efficiency by reducing the number of times a patient has to be repositioned, expanding the benefits of lateral surgery to more spinal levels and decreasing the amount of time a patient is under anesthesia.

“NuVasive earned its reputation as the disruptive leader in spine when we created the lateral market 15 years ago, and we’ve remained relentlessly focused on advancing and expanding our technology to transform patients’ lives, surgical practices and hospitals’ ability to provide superior, best-in-care patient results,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “We are transforming spine surgery around the globe through our unique technology including lateral single position surgery, the most advanced interbody implants with advanced materials science, including porous PEEK and 3D-printed porous titanium, and integrated O.R. systems that support spinal alignment, radiation reduction and imaging.”

Lateral Procedural Solutions
NuVasive expands its lateral procedural solutions with Lateral ALIF, XLIF Crestline and Lateral MAS Fixation, enabling surgeons to treat pathologies from T6-S1 to deliver efficient, predictable clinical outcomes.

  • The Lateral ALIF procedure is built on a new retractor system designed to provide direct access to L5-S1 with the patient in a lateral decubitus position. With the characteristics of a traditional supine ALIF, Lateral ALIF enables the surgeon to perform lateral single-position surgery, saving time and improving efficiency in the OR.
  • Built on the XLIF platform, XLIF Crestline is a supplemental solution, designed to gain lateral access to challenging L4-L5 levels where an XLIF cannot be performed, such as high crest, anterior psoas or an anterior plexus. The off-angle procedure allows access to disc space traditionally reached through a posterior approach, and uses the Company’s leading technologies including NVM5®, MaXcess® and XLIF implants.
  • Lateral MAS Fixation is an adapted technique using Reline®, the Company’s best-in-class fixation system designed to preserve and restore spinal alignment. The surgical technique provides surgeon partners reproducible results and increased O.R. efficiency when utilized with the Company’s leading lateral procedural solutions portfolio.

“NuVasive continues to take ownership of the lateral surgery, making it better for us as surgeons and making it better for our patients,” said Dr. Brian Kwon, orthopedic surgeon at New England Baptist Hospital. “Using XLIF, XLIF Crestline and Lateral ALIF provides the advantage of maintaining your patient in a single position. If you look, most of lumbar fusion surgery has really been done at L4 to S1, and so the ability to have these procedures available is tremendous.”

Advanced Materials Science Portfolio
Paving the way in spine surface technology, the Company unveiled its Advanced Materials Science (AMS) portfolio designed to deliver enhanced osseointegration and biomechanics through innovative implant design. With leading advanced materials in surface, structure and imaging characteristics, the portfolio includes the Company’s recently launched Modulus™ XLIF, a 3D-printed porous titanium implant, and porous PEEK™ (polyetheretherketone) technology after last month’s acquisition of Vertera Spine. NuVasive is the only medical device company to offer porous interbody technology across both PEEK and titanium materials, thereby addressing the spectrum of surgeons’ needs and preferences for advanced interbody implants. The Company’s future plans include integrating the porous PEEK technology across all its procedural offerings

The expanded lateral solutions and AMS portfolio demonstrate the Company’s deep commitment to bold innovation. These advancements in spine care join NuVasive other breakthroughs like Integrated Global Alignment® (iGA), a platform of procedurally based technologies designed to enhance clinical and economic outcomes by increasing the predictability of achieving global spinal alignment, advanced neuromonitoring with the NVM5 system, and radiation reduction with LessRay®.

NuVasive 2017 NASS Annual Meeting Participation Details
NuVasive will showcase its market-leading, procedurally-integrated technologies, including the new Lateral ALIF, Modulus XLIF and LessRay in NuVasive Booth #713 at the NASS Annual Meeting held October 25-28, 2017 in Orlando, Fla.

The Company also will host a surgical innovation lab demonstration presented by Robert Isaacs, MD, Mark Medley, MD, William D. Smith, MD, and J. Alex Thomas, MD, titled “Single Position Lateral Solutions to Treat L4-S1, Featuring Advanced 3D-Printed Implants and LessRay Radiation Emission Reduction Technology” on October 26, 2017 from 8:00 a.m. to 10:00 a.m. in the Green Lab at the Orange County Convention Center.

Visit here for more details and a schedule of events.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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SpineTop Stories

K2M Acquires World’s First & Only FDA-Cleared Cervical Static Corpectomy Cage

October 23, 2017 OrthoSpineNews

LEESBURG, Va., Oct. 23, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it has acquired from Cardinal Spine, a privately held medical device company, the PALO ALTO® Cervical Static Corpectomy Cage System. PALO ALTO, a cervical vertebral body replacement device, is the first and only static corpectomy cage in the world to receive a cervical 510(k) clearance from the U.S. Food & Drug Administration (FDA). In addition to PALO ALTO, K2M has also acquired the associated intellectual property and product inventory.

The PALO ALTO Cervical Static Corpectomy Cage System is indicated for use in the cervical spine in skeletally mature patients to replace diseased or damaged vertebral bodies, or for reconstruction to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. It is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft, as an adjunct to fusion.

“K2M has always impressed me with their innovative technologies. I’m elated about PALO ALTO; the long-term clinical data showed a 96 percent fusion rate,” said Frank P. Castro Jr., MD, an orthopedic surgeon at Baptist Health Floyd in New Albany, Indiana, and founder of Cardinal Spine. “The trapezoidal design helps increase the graft-host surface contact area, while providing resistance to posterior cage migration.”

The PALO ALTO Cervical Static Corpectomy Cage System will be featured in a scientific session at the 2017 North American Spine Society(NASS) meeting. The presentation entitled, “Cardinal Spine, LLC: ACCF: 30-Month Follow-Up on C-VBR,” will be facilitated by Dr. Castro on Wednesday, October 25 from 2:29 to 2:35 p.m. in Room W230CD.

“We are excited to expand our complex cervical offerings by adding the first and only FDA-cleared static cervical vertebral body replacement device,” said K2M Chairman, President, and CEO Eric Major. “We look forward to fully integrating this clinically supported technology into our differentiated product portfolio, which when complemented by our comprehensive Balance ACS™ platform, allows surgeons to address the full range of spinal pathologies, and ultimately, to facilitate Total Body Balance in their patients.”

During NASS, K2M will showcase PALO ALTO, as well as several of its latest offerings, at Booth #509. For more information on K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on August 2, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:

Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

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Spine

Stryker’s Spine Division to Launch Tritanium® C Anterior Cervical Cage at NASS 2017

October 23, 2017 OrthoSpineNews

October 23, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will introduce its Tritanium® C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, at the North American Spine Society (NASS) Annual Meeting, Oct. 25-28, 2017, in Orlando, Fla. (booth No. 500).

The Tritanium C Anterior Cervical cage is the newest addition to Stryker’s expanding line of spinal implants constructed from its proprietary Tritanium Technology,1 a novel, highly porous titanium material designed for bone in-growth and biological fixation.1 The unique porous structure of Tritanium is created to provide a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study,2* and the Tritanium material may be able to wick or retain fluid, in comparison to traditional titanium.3 It is inspired by the microstructure of cancellous bone4 and enabled by AMagine™, Stryker’s proprietary approach to implant creation using additive manufacturing, also known as 3D printing.

“After the terrific feedback and success we’ve seen with the Tritanium PL Posterior Lumbar cage, we are excited to introduce the Tritanium C Anterior Cervical Cage to spine surgeons this year at NASS,” said Bradley Paddock, President of Stryker’s Spine division. “Tritanium Cages feature ‘precisely randomized’4 pore formations, in contrast to other technologies with longitudinal channels and traverse windows that result in a uniform structure, as well as cages that offer porosity only on the surface. As a result, Tritanium implants are designed to become ‘one with bone’.”

“The ultimate goal with spinal implants is to get a solid fusion,” said Dr. Jocelyn Idema, a spine surgeon with Advanced Orthopaedics and Rehabilitation in Pittsburgh and Washington, Pa. “Spinal implants created with Tritanium Technology mimic the porosity of cancellous bone, which aids in fusion.”

Stryker’s Spine division also will present an abstract at NASS, titled, “Evaluation of Bony Fusion with Tritanium PL Used in Mini-Open Approach to Posterior Lumbar Interbody Fusion,” on October 26 at 1:41 p.m. ET, during the Innovative Technology Presentations.

The Tritanium C Anterior Cervical Cage received 510(K) clearance from the U.S. Food and Drug Administration in September 2017. It features an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence. In addition, the large graft window allows for bone graft containment. Engineered for stability,5,6 the cage has precisely angled teeth on the superior and inferior surfaces designed for bidirectional fixation and to maximize surface area for endplate contact with the cage. Its smooth posterior edges are designed to facilitate insertion and protect soft tissue and anatomy. The Tritanium C Anterior Cervical Cage is offered in a number of footprints, heights, and lordotic angles to accommodate a variety of patient anatomies.

Intended Use for U.S.

The Tritanium C Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc. The cage is to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. For the full Indications for Use, please refer to the Tritanium C Anterior Cervical Cage Instructions for Use.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com and www.stryker.com/builttofuse/. Follow Stryker’s Spine division on Twitter @stryker_spine.

References

1. PROJ43909 Tritanium technology claim support memo
2. RD0000053710: Tritanium cell infiltration and attachment experiment
*No correlation to human clinical outcomes has been demonstrated or established
3. RD0000050927: Tritanium material capillary evaluation
4.

Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491
5. PROJ0000054458 | Tritanium C Insertion and Expulsion Marketing Memo.
6. PROJ44960: Coefficient of friction memo

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Content ID: TRICC-PB-1_15825

Photo courtesy of Stryker

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374-6174
bsullivan@sullivanpr.com

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BiologicsSpine

RTI Surgical® Showcases TETRAfuse® 3D Technology in Peer-to-Peer Cadaveric Training Symposium

October 23, 2017 OrthoSpineNews

Lacey Jones/October 23, 2017

RTI Surgical’s spine sales & marketing teams hosted a Spine Symposium and Cadaveric Training in Las Vegas on September 16, 2017. This symposium – which was the second spine-focused symposium of the year – provided orthopedic and neurological spine surgeons from across the U.S. with key information related to RTI implants and instrumentation.

Attendees were able to gain hands-on experience with RTI’s recently-introduced TETRAfuse® 3D Technology, which provides surgeons a solution they have been seeking. TETRAfuse 3D Technology is the first 3D printed polymer implant material that has demonstrated trabecular bone ingrowth while maintaining radiolucency and bone-like mechanical properties*.

TETRAfuse 3D Technology was developed to offer surgeons an interbody material that participates in the fusion process while maintaining bone-like mechanical properties and radiolucent imaging. Bringing these features together combines the osseointegrative advantages of titanium and allograft bone with the benefits surgeons experience with PEEK. RTI will soon announce the release of a family of products manufactured with TETRAfuse 3D Technology, providing a platform that will have many derivative products.

 

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Spine

Kapstone Medical Acquires Loukas Medical Assets

October 23, 2017 OrthoSpineNews

CHARLOTTE, N.C. (PRWEB) OCTOBER 23, 2017

Kapstone Medical announced today they have acquired the assets of Loukas Medical, an independent orthopedic engineering firm based in Franksville, WI. Loukas Medical will expand Kapstone Medical’s portfolio with greater access to a diverse customer base, highly experienced engineering talent, and key intellectual property.

Loukas Medical has a history of assisting medical device companies in orthopedics and spine product development and manufacturing. James Rinner, Founder of Loukas Medical, is an inventor on 60 U.S. patents. Under the terms of the agreement, Jim will join Kapstone’s team of medical device experts in engineering, development, regulatory, quality and supply chain management.

“We are excited to welcome Jim to our team,” said John Kapitan, CEO and Founder of Kapstone Medical. “He is not only a highly talented and experienced engineer, but even more importantly to me, we share common corporate and personal values, paving the way for successful long-term collaboration.”

Kapstone Medical partners with medical device inventors and OEMs to rapidly develop and commercialize new medical devices inventions, on time and on budget. The company will be leveraging its produce development resources to develop and license a novel bone screw technology that Loukas designed and patented.

“The closing of this transaction opens new opportunities,” said Mr. Rinner. “We’re excited to be part of the Kapstone Medical team and look forward to creating value for our customers as we make a positive impact on the industry.”

John Kapitan & Jim Rinner will be attending the North American Spine Society (NASS) in Orlando, FL from October 25-28, 2017. If you would like to set up an appointment, please contact John at 704-516-5120.

For the latest news with Kapstone Medical follow them on LinkedIn.

About Kapstone Medical
Kapstone Medical has been helping innovators develop and safeguard their ideas since 2007. Kapstone is a privately held product realization firm headquartered in Charlotte, North Carolina. The company integrates a suite of in-house disciplines to give physician inventors, entrepreneurs and manufacturers of all sizes the opportunity to efficiently develop new ideas on time and on budget. Kapstone Medical’s range of services includes all aspects of product development, IP protection, regulatory, quality assurance, and supply chain management.

For more information please contact:
Guillaume Viallaneix
MedTech Momentum
phone: 407-960-2994
info(at)kapstonemedical.com

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Spine

Additional Payor Positive Coverage for A Novel & Proven Treatment For Lumbar Spinal Stenosis

October 23, 2017 OrthoSpineNews

NEW YORK, Oct. 23, 2017 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis announces updated coverage by Health Alliance Plan of Michigan. An additional 500,000 lives in Michigan now have access to treatment of lumbar spinal stenosis using coflex.

Lumbar spinal stenosis (“LSS”), affecting 1.6 million patients annually, is a debilitating and degenerative disease in older patients (>50 yrs) often associated with significant leg and back pain, leg numbness and weakness, causing a significant reduction in an active lifestyle. Traditional surgical treatment options for LSS include a decompression that removes bone and soft tissue and may also require a fusion to stabilize the spine. The coflex® device is a non-fusion, motion preserving stabilization implant, that is FDA PMA approved for the treatment of lumbar spinal stenosis, and can be used in conjunction with a decompression or used in lieu of a spinal fusion.

To learn more about coflex® Interlaminar Stabilization®, please visit www.coflexsolution.com.

Marc Viscogliosi, Chairman & CEO – “With over 85 peer-review published articles, including landmark 5 year follow-up studies, medical society guidelines, and now with additional commercial insurance coverage, it is wonderful to be able to expand patient access to the coflex® technology.”

About Paradigm Spine, LLC
Paradigm Spine, LLC was founded in 2004 and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company’s signature product is the coflex® Interlaminar Stabilization®device, which has more than 20 years of clinical history and patients treated in more than 40 countries worldwide.

 

SOURCE Paradigm Spine, LLC

Related Links

http://www.paradigmspine.com

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BiologicsSpine

OrthoSpineNews Interview with Charanpreet Bagga, Prosidyan’s President and CEO and Renowned Surgeon Dr. Hyun Bae

October 20, 2017 OrthoSpineNews

At OrthoSpineNews, we enjoy attending all the conferences and learning about new technology. There aren’t many areas in orthopedics and spine that has seen more growth, development and enthusiasm over the past few years but one of the shining stars is the Orthobiologics space. One of the most intriguing technologies that we have seen in this segment is the bioactive glass product called Fibergraft which is manufactured by Prosidyan.

We had the opportunity to sit down with Prosidyan’s President and CEO, Charanpreet Bagga (CB) as well as one of the leading surgeons in the country, Dr. Hyun Bae to learn more about the company and the product.

How about we start out with you both taking a minute to introduce yourself for our audience. 

CB- I have been very fortunate to have worked on a variety of exciting projects and for a number of great companies over the years.  Over the last 25 years, I have worked for Howmedica, Spinetech, Orthovita, Orthofix and Prosidyan as a full-time employee and I also helped build Titan Spine and Knee Creations as a consultant.  Over the years, I am a named inventor in over 125 US Patent applications, with over 50 issued patents, spanning hardware and biomaterials associated with treatments for back and knee pain.

Bae- I graduated from Columbia in NY with a degree in Biomechanical Engineering.  Looking back the biggest impact to my career choice was working in the Orthopaedic Research Lab as an undergrad with a world renown leader in cartilage and bone biology named Dr. Van C. Mow.  His post docs are now the Directors of many leading academic institutions and are the preeminent thought leaders in the field of musculoskeletal science.  From there I completed my medical training at Yale School of Medicine and continued research during my medical training by spending a year at the NIH as a Howard Hughes Fellow.  I completed my orthopaedic training at the Hospital for Special Surgery and spine fellowship with the late Henry Bohlman in Cleveland.

What led you to create Prosidyan and more specifically, Fibergraft? 

CB- Infuse was a Billion-dollar product in 2006.  By late 2008, we had seen a rapid decline in the market share of Infuse, which created a void in the bone grafting market.  Dr. Bae and I met around that time and felt that there was an unmet clinical need for a viable synthetic bone graft. We researched the field and narrowed in on bioactive glass as the most promising material.  Bioactive glass at that time already had a strong body of research to support its amazing properties, but had the limitations of only being available as crushed glass or as solid microspheres, with no porosity.  We had learnt over the years how important three-dimensional porosity providing direct cell connectivity is for allowing bone growth.  I decided to visit MoSci, the global dominant manufacturer of bioactive glass.  It led to a joint collaboration between Prosidyan and MoSci to develop FIBERGRAFT.

As a surgeon, what about Fibergraft do you most appreciate?

Bae- I love the fact that Fibergraft is truly a paradigm shift in grafting.  Most synthetics look like cancellous bone.  The problem is that they either resorb too quickly and you are not left with much or they are inert and do not resorb.  I feel we have been disenchanted with synthetics that look good on x-ray but on reoperation are found to be present in a deteriorated state without any true bone formation.  We have learned from BMP that bone induction is less about the providing a scaffold that looks like bone but more about enhancing the cellular healing process.  Fibergraft consists of micro and nano-sized fibers that are thoughtfully engineered in a 3-D structure to specifically induce and optimize the cellular process of bone development.     

BioActive Glass products have been around since VITOSS, what makes this different? 

CB- We are the first company to commercialize nano and micro sized fibers of bioactive glass for bone grafting.  Everyone else had solid particles, with no porosity.  Fibers allow the ultimate flexibility in engineering.  Our 3-D fiber array allows not only engineered porosity but direct cell connectivity.  This makes all the difference in ability to create rapid and sustained bone formation.

We have heard many different responses from surgeons regarding the quality of a fusion. Some say it’s the implants and biologics while others will say it’s the carpentry skills of the surgeon. What have you experienced and why do you think Fibergraft is displaying such great results? 

Bae- Obviously its all of the above.  But having trained fellows for the past 15 years, I am proud to say that the level and skill of spinal surgeons have advanced tremendously.  BMP taught us that we do not need iliac crest autograft in every fusion.  By advancements in implant technology and importantly knowledge and skill of the surgeon we have been able to achieve great results and outcomes for our patients without iliac crest autograft.  Fibergraft is just a well-deserved and needed evolution in synthetic bone grafting.  The results are a simple derivative of applying sound science and innovative engineering to the field of synthetic bone biology.

All publically traded orthopedic and spine companies have noted negative pricing pressure on their quarterly calls over the past few years, how has it been to create a new and innovative company while facing the same challenges? 

CB- This is a new world.  Gone are the days when you could spend unlimited amount of money in the development cycle with the promise of huge payback someday.  We ran Prosidyan very lean right from the beginning.  I worked from my home office for the first five years until we were close to our first FDA clearance.  We spent most of our funds directly on R&D and we stayed away from any expenses which were not absolutely needed.  I am proud to share that we have been operationally profitable, right from our first full year of commercial operations.

BMP’s like Infuse took the market by storm in the early 200’s but it appears that the product has been losing market share to products like Fibergraft, why do you think that is (clinical results? Finances?) 

Bae- First I think that BMP revolutionized the grafting market.  For all intensive purposes it put an end to the use of iliac crest autograft.  I do feel like this was a great thing for our patients.  It allowed the exploration of alternatives to iliac crest to be put to use.  The two main alternatives are allograft and synthetics.  I truly feel that we just fell behind in the synthetic category.  There is no reason with the advancement of technology and science today that a synthetic bone graft cannot be engineered to equal autograft.  It just took us a long time to understand and apply technological innovations to synthetics.  Fibergraft is an incredible and thoughtful application of todays technology in synthetic bone grafting.  Its clinical results speak for themselves and it is the best synthetic bone graft available today.

Thank you both for taking the time to sit down with us and share the exciting story of Prosidyan and Fibergraft. You will be at NASS and I’m sure if anyone reading this has questions, it would be highly recommended for them to stop by your booth (#1730) while they are in Orlando. We wish you both the best of luck and thank you again for sharing this exciting story.

 

 

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Spine

Spineology Initiates Post-Market Lateral Interbody Fusion Study Using Novel Implant Design

October 20, 2017 OrthoSpineNews

October 20, 2017

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving spine surgery, has announced the initiation of a prospective, post-market lateral interbody fusion study designed to evaluate patient outcomes using its FDA-cleared Duo™ Lumbar Interbody Fusion System.

The Duo System offers a unique implant design that is the first to combine PEEK, titanium, and graft containment mesh elements. The design dramatically reduces the access required to implant a device compared to traditional lateral systems. By minimizing the nerve and soft tissue retraction typically required in these surgeries, the company believes the Duo System can reduce the post-operative thigh pain and other complications commonly associated with the lateral approach. In addition to reducing the exposure required for placement, the Duo implant, once filled, creates a large, load-sharing, endplate-conforming graft pack that expands up to 30mm in width to help maintain spinal correction and support fusion.

“We think minimizing the amount of retraction by having the ability to efficiently place a narrow implant and then expanding the implant up to 30mm in width once deployed, offers significant clinical benefits to the patient as well as procedural benefits to the surgeon,” said John Booth, CEO, Spineology Inc. “The Duo System represents next-generation fusion technology and we’re extremely excited to see the clinical results of patients treated in the post-market study,” added Booth.

Post-market study sites for the Duo System are in the process of being finalized.

The Duo Lumbar Interbody Fusion System will be highlighted at the Spineology booth, #913, at the North American Spine Society (NASS) annual meeting next week in Orlando, Florida.

About Spineology Inc.

Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

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ExtremitiesReconSpineTop Stories

Corin Group acquire Belgium & Luxemburg large joint business unit of MBA NV

October 19, 2017 OrthoSpineNews

18 October 2017

Corin Group, after the successful acquisition of the Tornier Hip and Knee business is announcing a further European expansion by acquiring the large joint business unit of MBA Belgium & Luxemburg NV.

Over the last 7 years MBA has successfully distributed the Corin portfolio. The team have gone from strength to strength, expanding and developing solid collaborative relationships with key surgeons throughout the countries. The combination of Corin technologies and the MBA team’s passion for orthopaedics will deliver greater value to the Belgium and Luxemburg Orthopaedic community.

Stefano Alfonsi, Chief Executive Officer of Corin commented “With MBA’s, responsive service and solid working relationships they are well placed to engage their attentive audience with Corin’s world leading innovative technologies. We are delighted to welcome the team who are transitioning to Corin from MBA and look forward to building an even stronger surgeon focused organisation.”

Paul Griffin, International Business Director, MBA, commented, “Building on MBA’s success in Belgium & Luxemburg in the recent past,  Corin’s involvement will streamline the representation from MBA and Tornier to a single Corin entity, simplifying the customer experience, and enabling more surgeons to engage with Corin’s Ecosystem of  ground breaking technologies’.”    

About Corin

Since its inception, Corin has led the way in orthopaedic innovation — providing a faster, positive and more assured return to quality of life for people all over the world. Today, as a dynamic, growing, global business, Corin’s approach is revolutionising orthopaedics.

We offer a unique combination of clinically-proven hip, knee, ankle and shoulder solutions and world-leading technologies that enable patients, surgeons and healthcare providers to connect more closely than ever.

The deep insight we gain, understand and share at every stage of the connected orthopaedic experience leads to advanced, patient-specific solutions that exceed expectations, maximise value in healthcare and positively impact lives.

About MBA

MBA is a leading company in the European medical and surgical technology field. Our objective is to create value for the specialist through technology, service and sharing knowledge.

MBA currently has two divisions:

MBA

The Company began by specialising in providing complete solutions for Orthopaedic and Neurosurgeons via a full range of product lines for the following specialities:

  • Knee
  • Hip
  • Shoulder
  • Other joints: Elbow, Hand, Wrist, Foot and Ankle.
  • Tumour and Extremity Reconstruction
  • Biomaterials
  • Spine
  • Trauma

BIOSER

This Division provides solutions for nine surgical specialties: Anaesthesiology, General Surgery, Cardiovascular Surgery, Thoracic surgery, Urology, Gynaecology, Obstetrics, ENT, Plastic Surgery and Emergency Medicine.

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