Spine – Page 59 – Selby Spine

ATLANTA, GA (PRWEB) JULY 11, 2017

Back Pain Centers of America (BPC), which connects people searching for solutions to their neck and back pain with a reputable physician in their area, announces that Stryker’s Spine division is a finalist in the 2017 Awards of Excellence for the Technology Innovation Award. This award is one of three categories of awards being presented in our 2017 series. The Technology Innovation Award recognizes the top innovations advancing the field of orthopedic medicine, and Stryker’s Spine Division is being honored for its LITe BIO Delivery System.

The LITe BIO Delivery System is a uniquely designed hand-held device used to facilitate delivery of bone graft material to spinal surgery sites. The first-of-its-kind design of the LITe BIO Delivery System provides surgeons with a single-handed method to deliver any type of autograft, allograft, or synthetic bone graft material without obstructing visibility. The innovative delivery tool provides tactile, visual, and audible confirmation of bone graft delivery, and the mallet-free system eliminates the impaction of bone graft.

“We are pleased to be recognized as a finalist in the Technology Innovation Award category,” said John Mayor, Vice President, Global Marketing for Stryker’s Spine division. “The new LITe BIO Delivery System combines three key features—a low-profile design, the versatility to accommodate any graft material, and direct visualization to aid in the precise placement of the graft. The LITe BIO Delivery System’s design offers a combination of features that no other bone graft delivery system on the market possesses.”

“We created this award category to recognize innovation and advances in medicine and technology,” said Brent Wheeler, president of Back Pain Centers of America. “We applaud Stryker’s Spine division for its innovation in addressing existing challenges in spinal fusion procedures.”

More information about the LITe BIO Delivery System can be found here.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at http://www.stryker.com.

About Back Pain Centers of America
Back Pain Centers of America (BPC) has helped people find safe, reliable relief for chronic pain since 2009. The call centers match patients searching for relief for neck and back pain to reputable, board-certified healthcare practices in their geographic area. BPC has the largest network of minimally-invasive spine centers in America. This service is free to patients. For more information, please visit http://www.backpaincenters.com. Also follow BPC on LinkedIn, Facebook, or Twitter.

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WALNUT CREEK, Calif., July 10, 2017 /PRNewswire/ — Providence Medical Technology, Inc., a developer of innovative cervical spine technology, announced the publication of multiple independent studies demonstrating the results of its tissue-sparing posterior cervical fusion technology.

In the first study published by Lenzi J, et al. in World Neurosurgery (2017), the authors report results from the first ever prospective, randomized, controlled trial comparing operative results using the DTRAX® Expandable Cage system versus conservative care for patients diagnosed with single-level cervical radiculopathy. The study presents data on 40 patients from each group. The paper reports significant improvements in VAS neck and arm pain relative to the control group at all time points out to one year. The paper also reports marked improvements from baseline in NDI and SF-36. This publication was completed independent of any conflict of interest from the authors and not sponsored in any way by the company. The table below summarizes the VAS results.

	Pre	1 Month	6 Months	12 Months
Surgery
VAS neck	5.725	1.925	0.75	0.33
VAS arm	8.65	0.575	0.35	0.25
Conservative Care
VAS neck	5.475	3.8	1.5	1.05
VAS arm	8.775	5.35	3.615	1.77

A complete copy of this study can be found at http://dx.doi.org/10.1016/j.wneu.2016.12.125

In the second publication by William Smith, et al. in Operative Neurosurgery (2017), the authors report the results of bilateral posterior cervical fusion cages for the treatment of anterior cervical pseudarthrosis again through the use of the company’s flagship tissue-sparing DTRAX Spinal System and CAVUX® Cervical Cages. This study was not sponsored by Providence in any way; however, some of the investigators and authors of this publication maintain ownership and compensation relationships with Providence. This paper reports results of 25 patients at a mean follow-up of 18 months. The table below summarizes improvements in VAS neck, VAS arm, and NDI scores. This study also reports that fusion was confirmed radiographically in all 25 patients.

	Pre-Op	Follow-up
VAS neck	7.9	3.8
VAS arm	7.24	3.12
NDI	65.1	29.1

A complete copy of this study can be found at http://doi.org/10.1093/ons/opx103

“We were delighted to receive notification of these recent publications adding to the growing body of clinical evidence supporting our innovative tissue-sparing posterior cervical fusion technology,” said Jeff Smith, CEO of Providence. “We are grateful for the work of these authors and particularly thankful to the patients who volunteered to participate in a randomized controlled trial to study the impact of our novel surgical approach. These independent studies represent two of the more common applications of our cervical fusion technology, and it is encouraging that new clinical evidence continues to support these use cases. We are committed to clinical research and look forward to additional publications moving forward.”

The DTRAX Expandable Cage System used in the first study is CE marked and indicated for posterior cervical treatment at C3-C7 (inclusive) spinal levels for the following: patient with single level radiculopathy due to degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets. The DTRAX Expandable Cage System used in the first study is not cleared or approved by the FDA and is not available for order or sale in the United States.

The CAVUX Cervical Cage system used in the second study is CE marked and FDA cleared and indicated for use in skeletally mature patients, with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least size weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary, tissue-sparing approach to posterior cervical fusion. Providence has developed surgical instrumentation and implants that offer unique benefits to the $2 billionworldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY™ line of bone and facet screws. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com

For other clinical publications regarding this technology visit www.providencemt.com/clinical

SOURCE Providence Medical Technology, Inc.

Contacts

For Spinal Elements
Laura Charlton (formerly Johnson)
760.450.7749
laurajohnsonpr@yahoo.com

Written by Kristin Della Volpe

Research emerging from the Spine Biomechanics Laboratory at Texas Back Institute (TBI) may better elucidate the biomechanical and neuromuscular risk factors associated with spinal conditions and help define the most appropriate and effective treatment options.

Using human motion capture, dynamic electromyography sensors, and force plates technology, the lab is designed to quantify patients’ functioning before and after spinal surgery in terms of gait, balance, posture, muscle coordination, stair climbing, and sit-to-stand motion analyses. The data also is used to define muscle activation parameters: onset (when the muscle is activating), magnitude (how much the muscles are working), and volume (energy expenditure). Together, this information is used to quantify short-term (3-months) and long-term (1-year) functional improvement postsurgery in patients who participate in research studies at TBI.

Lab Provides Quantitative Outcomes Data
The lab “offers objective, quantitative, and reliable data for spine surgeons and physical therapists to use when assessing the functional outcomes of surgery,” explained Ram Haddas, PhD, MSc, MEng, Director of Research at the TBI Research Foundation in Plano, TX.

The lab was created to overcome the potential limitations of traditional measures of spine surgery outcomes, namely imaging findings and patient questionnaires (eg, Oswestry Disability Index, SF-36). Imaging findings are reliable but conducted in static positions and findings can change with movement, Dr. Haddas noted. In addition, patient questionnaires are subjective with studies showing that patients do not always understand the survey questions or how to estimate pain level, Dr. Haddas said.

“We now have robust irrefutable data manifesting patients’ ability to walk and stand better” after treatment, said Ralph Rashbaum, MD, Orthopedic Spine Surgeon at TBI. “This is something that, from a standpoint of ongoing research, becomes a necessity in musculoskeletal medicine.”

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CARLSBAD, Calif., July 07, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of Mariner® Posterior Fixation System.

The Mariner Posterior Fixation System is a pedicle based system featuring modular screw technology and accompanying instrumentation. Designed to reduce the number of trays needed for surgery, Mariner is intended to efficiently provide surgeons with multiple intra-operative options to facilitate posterior lumbar fixation. Mariner offers versatility and adaptability by providing surgeons with a variety of instrument and implant solutions for degenerative and complex spine pathologies, including choices in rod diameter, rod material, construct configuration, and deformity correction techniques. Key market differentiators include in-situ modularity, motion limiting heads, and rod versatility with both 5.5mm and 6.0mm offerings.

“In today’s hospital environment, the key is to have as many options as you can for your patient without overburdening your staff,” stated Douglas Orndorff, MD. “Mariner is versatile, yet simple to use. Ultimately, it helps me make intraoperative decisions seamlessly.”

Dr. Warren Yu, Director of Spine Surgery at George Washington Hospital commented, “Mariner’s state-of-the-art instrumentation and modular screw design provide me with the broad selection of implant configurations that I need to address the challenging patient anatomy I see in my adult spine practice – from basic degenerative to complex deformity cases.”

“The Mariner Poster Fixation System brings innovative features to the market and utilizes a modular design that increases surgeon flexibility while reducing the number of trays that need to be brought into the operating room,” stated Keith Valentine, Chief Executive Officer of SeaSpine. “The Mariner launch is an important enhancement to SeaSpine’s spinal hardware product offerings in the $1.8 billion posterior lumbar fixation market.”

About SeaSpine

SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development helps SeaSpine to offer its surgeon customers a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements

SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the design benefits of the Mariner Posterior Fixation System, including its potential to reduce the number of trays needed for surgery and provide surgeons with multiple intra-operative options to facilitate posterior lumbar fixation; and ability of the Mariner Posterior Fixation System to complete in the $1.8 billion posterior lumbar fixation market. Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the fact that the Mariner Posterior Fixation System has undergone only limited clinical validation and may not address adequately surgeon requirements; surgeons’ willingness to use the Mariner Posterior Fixation System; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com

SeaSpine Holdings Corporation

July 06, 2017

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Medacta International, the privately held family-owned global leader in the design of innovative joint replacement and spine surgery products, today announced that the company’s USA Spine Division delivered strong growth in the first quarter of 2017 and introduced key new products that will continue to expand Medacta’s offerings in the spine field.

Coming off the appointment of a new medical director and important product launches, the Medacta USA Spine Division nearly doubled its sales revenue from the comparable quarter last year. The division released three new products in 2016, including the MySpine Low Profile Guide, receiving numerous accolades for their clinical success and high praise from the surgeons who use them.

Francesco Siccardi, Executive Vice President of Medacta International, commented: “Medacta always strives to produce exceptional products that are built around surgeon feedback and provide the best possible patient experience. The success of this team is a proof point for the Medacta way: a maintained focus on surgeon education and smart design.”

Medacta’s latest innovation, the MectaLIF Anterior Hybrid Interbody Fusion Device, was cleared by the U.S. Food and Drug Administration (FDA) in February 2017 and will be an addition to the MectaLIF Cage product suite. The MectaLIF System aims to provide enhanced in situ stability, restoration of the native disc space height and lordosis, and long-term maintenance of the spinal balance. With the addition of the new hybrid configuration, the MectaLIF product line will now offer four different configurations (hybrid, anterior flush, anterior long, and anterior L5-S1), three footprints, two materials (PEEK or Titanium-coated PEEK (TiPEEK)), and hyperlordotic 20-degree cage options, allowing surgeons to target any patient-specific abnormalities they may encounter.

“The addition of the hybrid makes MectaLIF even more versatile,” said Dr. S. Raymond Golish, Medical Director of Medacta’s Spine Division. “We offer surgeons a wide variety of implants tailored to surgeon technique and patient anatomy to optimize outcomes.”

The addition of the MectaLIF hybrid configuration will enable personalized care for patients where additional stability is required and low profile construct is necessary to deal with difficult, tilted anatomies, by offering a flush caudal and long cranial profile in conjunction with low angle, diverging screws. In addition to the new configuration, the FDA cleared the hyper lordotic option and a 40x30mm footprint to further supplement the MectaLIF product suite and offer a wider array of options to patients.

About Medacta

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

LEESBURG, Va., July 06, 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 it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a CE Mark for its NILE® Proximal Fixation Spinal System, a spinal system specifically designed for proximal construct augmentation. NILE Proximal Fixation addresses complex spinal deformity cases and consists of bands and connectors that may be used in conjunction with spinal rod constructs for attachment to the posterior vertebral structures at the proximal end of the construct. The CE Mark for NILE Proximal Fixation also includes the use of anchors, which are not cleared for use in the United States.

“I have used many band technologies for proximal construct augmentation from different companies and NILE Proximal is a huge leap forward in simplifying the design to achieve this goal,” said Greg Mundis, MD, a surgeon specializing in pediatric and adult spinal deformity surgery in the Department of Orthopedics at Scripps Clinic Medical Group in La Jolla, California. “K2M has made it elegant and efficient to place the connectors and tension the bands in a predictable fashion.”

I am excited about this addition to the NILE product family,” said John Ferguson, MD, an orthopedic spine surgeon in Auckland, New Zealand. “The implants are straightforward and easy to use. I think this product will be a very useful addition to many of my complex procedures.”

NILE Proximal Fixation has a versatile application in complex procedures, from scoliosis to adult degenerative. The NILE bands are manufactured from polyethylene terephthalate and can be used to provide additional fixation in a MESA® , MESA 2, EVEREST®, or DENALI® Spinal System construct through sublaminar passage or attachment to an anchor (OUS only). The band can then be integrated into the construct using the NILE transverse or medial offset connectors.

“Similar to our recent announcements around MOJAVE™ PL 3D Expandable, SAHARA® AL Expandable, and CAPRI™ Small 3D Static, we are incredibly proud to announce yet another innovative technology in NILE Proximal Fixation,” stated K2M President and CEO Eric Major. “This regulatory milestone—coupled with the recent launch of our Balance ACS™ platform— further emphasizes our focus on achieving three-dimensional spinal balance, and ultimately Total Body Balance, for patients.”

Balance ACS (BACS™) provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information about the NILE Proximal Fixation Spinal System and K2M, visit www.K2M.com. For more information about 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 threedimensional 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; in adequate 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; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; 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; 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, 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 forwardlooking 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

(PR NewsChannel) / July 3, 2017 / Austin, Texas

Randall F. Dryer, MD, FACS, Spine Specialist Surgeon at the Central Texas Spine Institute, and affiliated with the Arise Austin Medical Center and Seton Medical Center Austin, has been named a 2017 Top Doctor in Austin, Texas. Top Doctor Awards is dedicated to selecting and honoring those healthcare practitioners who have demonstrated clinical excellence while delivering the highest standards of patient care.

Dr. Randall F. Dryer is a very experienced surgeon, having been in practice for more than 39 years. His medical career started in 1977, when he graduated from the University of Iowa Carver College of Medicine in Iowa City. After an internship and residency at the University of Iowa Hospitals, he completed a fellowship in Spine and Hand Surgery at the prestigious Cambridge University in the United Kingdom.

Dr. Dryer is certified by the American Board of Orthopaedic Surgery, and he provides both surgical and non-surgical treatments for many conditions and traumas, but he is particularly known for his expertise as a spine surgeon. Among the expert procedures undertaken by him are spinal fusion and spinal cord stimulation, herniated disc surgery, spinal nerve block, and cervical disc replacement.

READ THE REST HERE

July 03, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders today announced the full commercial launch of key additions to the OSSEO-LOC™ spinal implant family.

ProLift^® Expandable PLIF/TLIF Spacer System and TiBOW™ Expandable TLIF Spacer System join Life Spine’s OSSEO-LOC offering of titanium surface treated implants. OSSEO-LOC is a proprietary surface treatment that creates a unique osteophylic surface architecture for potential bone on-growth.¹ The unique surface architecture promotes mineralization of implant, while negating potential challenges associated with surface treated implants.² OSSEO-LOC surface treatment maintains native titanium grain structure and material, and has been designed to optimize intervertebral stability.¹

Other key OSSEO-LOC implants include the static spinal spacer systems PLATEAU^®-C (cervical spacer system), PLATEAU-Z Ti (TLIF spacer system), PRO-LINK^® TI (stand-alone cervical spacer system), PLATEAU TI (straight and curved PLIF and TLIF spacer systems); SImpact™ lag and compression screws for sacroiliac fixation and stabilization.

Mariusz Knap, Vice President of Marketing noted, “We are excited to launch the key additions to the OSSEO-LOC family of spinal implants, as it deepens Life Spine’s commitment to provide surgeons with access to our highly differentiated, minimally invasive spinal products. Addressing a variety of pathologies, Life Spine’s procedural based solutions increase the value of care by delivering both the ability to correct spinal alignment and improved patient experiences and outcomes. This will be a driving force as we continue to expand Life Spine’s wide range of surgical solutions.”

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

¹Feighan, J.E., Goldberg, V.M., Davy, D., Parr, J.A., Stevenson, S.
“The Influence of Surface Blasting on the Incorporation of Titanium-Alloy Implants in a Rabbit Intramedullary Model.” The Journal of Bone and Joint Surgery 77.9 (1995): 1380-96. Web.

²K.Kieswetter, Z. Schwartz, T. W. Hummert, D. L. Cochran, J. Simpson and B. D. Boyan
“Surface roughness modulates the local production of growth factors by osteoblast-like MG-62 cells” The Journal of Biomedical Materials Research (1996): Web.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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ATLANTA, June 29, 2017 /PRNewswire/ — Meditech Spine, LLC, announced today it has received 510(k) clearance for its CURE Lumbar Plating (LP) System from the US Food and Drug Administration (FDA). The CURE LP allows surgeons to utilize the lumbar plating system along with Meditech’s innovative lumbar Talos® fusion devices, which are manufactured with PEEK-OPTIMA™ HA Enhanced polymer offered by Invibio Biomaterial Solutions. These devices are essential in the market, as an estimated 25 percent of thoraco-lumbar interbody fusions are performed via the anterior and lateral approaches.

The CURE LP is:

A low profile titanium plate that incorporates a proprietary, one-step locking mechanism to prevent bone screws anchored on the spine from loosening and backing out.
Designed with a large graft window for viewing the interbody space.
Pre-lordosed for lumbar sacral applications.
Available for both anterior and lateral procedures as four-hole or two-hole plates.

“As the anterior and lateral surgical approaches continue to grow, especially as they relate to global sagittal balance and alignment of the spine, we are pleased to receive this clearance so quickly after the clearance for our ALIF and LLIF Talos® HA Peek spacers earlier this month,” says Eric Flickinger, co-founder of Meditech Spine. “This accomplishment is really a testament to our team for their focused efforts in achieving two major milestones this year, and we are privileged to add value to our implant solutions for surgeons and their patients.”

The CURE LP and Talos®-A (HA) Lumbar IBF device will be combined in one tray with streamlined instruments to make it easier for hospital and surgery centers to process the system. Both systems will be provided sterile and pre-packaged to reduce implant related infections and help with implant tracking.

Meditech began its partnership with CURE International, an organization that serves children with physical disabilities in underserved areas of the world, during the development of its CURE Anterior Cervical Plate (ACP), introduced last year. “We are excited to continue building upon our relationship with CURE International and inspired to see how they work tirelessly around the world, bringing healing and hope to those who are less fortunate,” says Flickinger. A portion of proceeds from the sale of every CURE LP plate will help CURE International treat patients in underserved areas who are in need of surgical care.

For more information visit Meditech Spine.

ABOUT MEDITECH SPINE, LLC

Meditech Spine, LLC, is a spinal device company developing innovative instrumentation for treating complex spinal issues. It partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. Meditech’s pursuit of novel and innovative technologies drives its design and development team. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best available technologies.

CONTACT

Meditech Spine, LLC
(678) 974-5287
support@meditechspine.com

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SOURCE Meditech Spine, LLC

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K2M Receives FDA Clearance & CE Mark for NILE® Proximal Fixation Spinal System

Expert Spine Specialist Surgeon, Randall F. Dryer, MD, FACS, is to be Recognized as a 2017 Top Doctor in Austin, Texas

Life Spine Announces Full Commercial Release of Key Additions to the OSSEO-LOC™ Product Family

Contacts

Meditech Spine Releases CURE LP System and Talos® HA Peek Spacers as Comprehensive Solution for Surgeons

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