Spine – Page 51 – Selby Spine

SCOTTSDALE, ARIZONA (PRWEB) SEPTEMBER 14, 2017

Ortho Sales Partners, a global leader in orthopedic sales commercialization services, is excited to announce the addition of Tim Hein as Vice President of Market Development, further filling out its team of orthopedic and spine industry veterans. Mr. Hein has spent his career introducing disruptive technologies to the market and has experienced great success as part of landscape changing acquisitions while at Kyphon and LDR Spine.

Mr. Hein provides yet another example of the commitment Ortho Sales Partners has made to its clients by attracting the industry’s top talent. Primary functions that Mr. Hein will lead fall in the areas of both strategic and tactical sales execution. Leveraging over 16 years of experience creating and managing high functioning, results oriented sales teams, Mr. Hein has developed processes that create predictable growth and success. A graduate of the United States Military Academy at West Point, Mr. Hein has demonstrated leadership and focus in each of his corporate roles.

Mr. Hein’s career progression is steady and has provided some of the best experiences and perspective available in the spine industry. With a career that started at JNJ, Mr. Hein was quickly promoted to Regional Sales Director at DePuy Spine. In 2006, he was recruited by Kyphon which was acquired by Medtronic for $4.2 Billion. In 2009 Mr. Hein joined LDR Spine, an early stage company with disruptive spinal technology, as a Regional Director of Sales. Mr. Hein was a key executive during his more than seven years at LDR Spine, culminating in the role as Area Vice President of Sales-West. He was retained by Zimmer Biomet after it acquired LDR Spine for $1 Billion prior to joining the sales leadership team at Ortho Sales Partners.

“I am very pleased to join Ortho Sales Partners and add to the comprehensive services offered” said Hein. “I look forward to the opportunity to work with clients in support of their success in a very dynamic market and time in our industry.”

“The addition of someone with Tim Hein’s pedigree is humbling for our team” said Josh Sandberg President, Ortho Sales Partners. “Tim will allow us to offer clients hands on focus and experience that will allow them to avoid common pitfalls of commercializing new products. His ability to consistently bring novel disruptive technologies to the market and succeed is a rare talent and we look forward to leveraging his experience to the benefit of our clients.”
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About Ortho Sales Partners

Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations such as:

A surgeon with a product idea and limited financial wherewithal to properly execute a sales plan.
OUS companies looking to establish or enhance their presence in the United States.
Companies with recent FDA approval in need of a strategic sales plan validated against current market conditions.
Established companies looking for sales and marketing horsepower to properly launch a new product.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis from industry stalwarts from some of the highest growth companies.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US. (http://www.orthosalespartners.com)

New-Nuvasive-less-ray-image-nuv_p_lessray.12.15.16rtx018-1-e1505319519304.jpg

SAN DIEGO, Sept. 13, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the commercial launch of its LessRay® software technology system. The LessRay system, comprised of a propriety software algorithm and hardware components, is designed to help address over exposure to radiation in hospital operating rooms (O.R.), particularly in the case of minimally invasive spine surgery (MIS).

“The launch of LessRay is a significant milestone for NuVasive, as we begin to sell capital equipment and bring technology advancements into the hospital O.R.,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “With LessRay’s ability to dramatically reduce radiation exposure, as well as its enhanced imaging capability, we are now executing on our imaging and navigation strategy to improve spine surgery productivity and ultimately predictability. Given the healthy pipeline of interest from customers already, the strong demand demonstrates a critical need for a solution like LessRay to address a major safety issue related to radiation facing surgeons and hospital administrators.”

LessRay Benefits
Studies show spine and orthopedic surgeons can receive their lifetime occupational radiation limit within the first 10 years of their career.¹ As a result, cancer rates and contraction of cataracts associated with radiation exposure are nearly double that of other surgery practices. LessRay’s proprietary image enhancement technology improves low-dose, low-radiation fluoroscopy (or x-ray) images to have similar diagnostic capabilities as conventional full-dose fluoroscopy images, thereby reducing radiation emission and exposure in the O.R while retaining the high resolution of a full radiation dose shot. Additionally, LessRay has other features to help reduce the number of fluoroscopic shots needed, thus decreasing the overall radiation even further. Results of a recent prospective study²conducted with patients randomized to which surgical intervals were performed with standard-dose fluoroscopy or fluoroscopy using LessRay, which measurement of radiation emission and exposure showed that radiation exposure of healthcare professionals in the O.R. was between 62 percent and 84 percent lower in the LessRay group compared to the conventional fluoroscopy group.

In addition, radiation exposure and limited imaging capabilities have been barriers to widespread spine MIS adoption, compared to general orthopedic MIS. By dramatically reducing these limitations, LessRay supports the increased adoption of MIS spine surgery and enables the well-documented patient benefits including less blood loss, lower risk of infection, faster recovery time and more. Additional hospital economic benefits include no disruption to current surgical workflow and no additional surgery time needed.

More about LessRay
NuVasive acquired the LessRay propriety software algorithm and technology system in September 2016, and has since improved upon its design. The Company completed robust alpha and beta testing in more than a dozen hospitals where spine surgery is performed, and incorporated trial feedback from surgeons and hospital staff. LessRay units will be sold as a capital sale or lease purchase, with a focus on selling into O.R.’s dedicated to spine surgery first and then proliferating the technology across additional areas of the hospital where this technology also solves a significant need.

Additional LessRay system benefits for spine surgeons and staff that help increase O.R. efficiency include:

C-arm tracking: Simplifies localization and target anatomy quickly, accurately and without the unnecessary fluoroscopy time and scouting images.
Image stitching: Minimizes surgical workflow interruption by quickly stitching together fluoroscopic images of any spine segment.
Angle finder: Minimizes O.R. steps required to obtain crisp endplate shots with fewer fluoroscopic images than traditional C-arm scouting.
Alternate view: Improves visualization by making metal instruments invisible or semi-transparent by fading out their obstruction.

“LessRay’s ability to reduce radiation usage is so compelling because it benefits not only the surgeon but also the patient and everyone in the operating room,” said Dr. Stephen Ryu, neurosurgeon at Palo Alto Medical Foundation in Palo Alto, Calif. “LessRay’s additional features that augment the capability of conventional fluoroscopy provide really useful tools for even the simplest surgeries. LessRay’s capability to assist accurate localization of spine levels alone is worth it.”

¹UI Haque M, Shufflebarger HL, O’Brien M, et al, Radiation exposure during pedicle screw placement in adolescent idiopathic scoliosis: is fluoroscopy safe? Spine 2006;31(21):2516-20.

²Wang TY, Farber SH, Perkins SS, et al. An internally randomized control trial of radiation exposure using ultra-low radiation imaging (ULRI) versus traditional C-arm fluoroscopy for patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion. Spine 2017;42(4);217-23.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is 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.

CONTACT: Investor Contact: Suzanne Hatcher, NuVasive, Inc., 858-458-2240, investorrelations@nuvasive.com; OR Media Contact: Stefanie Mazer, NuVasive, Inc., 858-320-5243, media@nuvasive.com

This information is being sent to you by:
NuVasive, Inc.
7475 Lusk Boulevard, SAN DIEGO, CA, 92121, United States
http://www.nuvasive.com

NEW YORK, Sept. 12, 2017 /PRNewswire-USNewswire/ — Todd J. Albert, M.D., surgeon-in-chief and medical director of Hospital for Special Surgery (HSS) was inducted as the 48^th president of the Scoliosis Research Society (SRS) at the 52^ndAnnual Meeting Course in Philadelphia, Pennsylvania on Saturday, September 9.

With over 1,000 members, SRS is an international society that was founded in 1966 with only 37 members. Current membership includes the world’s leading spine surgeons, researchers, physician assistants and orthotists who are involved in the research and treatment of spinal deformities.

Dr. Albert began his one-year term as president effective September 9. He has been a member of SRS since 1994 and has served in leadership positions including the chair of the Program Committee and the International Meeting of Advanced Spinal Techniques.

“I’m truly honored to lead this organization that has been a driving force in the field of spinal deformity,” said Dr. Albert. “As we continue to evolve into a global society, I hope to further advance the research, education and training that is necessary to bring high quality care to every patient with a spinal deformity.”

Dr. Albert joined HSS as surgeon-in-chief in 2014 and is also the Korein-Wilson Professor of Orthopaedic Surgery. Specializing in the field of orthopedic spine surgery, Dr. Albert focuses on disorders of the cervical spine. Additionally, he has an interest in minimally invasive surgical techniques and image guided technologies. He is the author of seven books and more than 40 book chapters and has published 300 peer-reviewed and non-peer-reviewed articles.

As president, Dr. Albert will travel both nationally and internationally to lecture and teach fellow spine surgeons. He will also oversee administration and the organization’s major meetings.

Outside of the OR, Dr. Albert loves biking, has a penchant for history and enjoys traveling. Dr. Albert lives in Manhattanwith his wife Barbara and has three adult children.

About Hospital for Special Surgery
Hospital for Special Surgery (HSS) is the world’s leading academic medical center focused on musculoskeletal health. HSS is nationally ranked No. 1 in orthopedics and No. 3 in rheumatology by U.S. News & World Report (2017-2018), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. HSS has one of the lowest infection rates in the country. HSS is an affiliate of Weill Cornell Medical College and as such all Hospital for Special Surgery medical staff are faculty of Weill Cornell. The hospital’s research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. HSS has locations in New York, New Jersey and Connecticut.
www.hss.edu

SOURCE Hospital for Special Surgery

BELGRADE, Mont., Sept. 12, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared product line extensions for the Irix-A interbody spacer. The clearance provides for the addition of three additional size configurations for an expanded market opportunity, and importantly, for use with allograft. This clearance is the second received during this quarter, and continues to strengthen Xtant Medical’s focus in providing a more comprehensive portfolio focused on regenerative care for the patient.

Xtant Medical’s Irix-A is a standalone interbody device used in anterior lumber interbody fusions. The current product line offers a titanium and PEEK composite implant, with the additional option of a titanium plasma coating for improved osseointegration with the spinal endplate, all with 8° or 12° of lordosis for alignment with the curvature of the spine. This new 510k clearance adds three additional degrees of lordosis, specifically 16°, 20°, and 24°, providing the surgeon with a wider variety of choices to correct the patient’s loss of lordosis and to improve sagittal balance. The FDA clearance also expands the indications of use to include use with allograft, such as Xtant Medical’s patented OsteoSponge, proprietary 3Demin, or OsteoVive viable cell allograft.

“The clearance of the additional footprints, including hyperlordotic options, further enhances our lumbar product portfolio in response to our customer’s needs,” said Gregory Juda, Chief Scientific Officer. “We continue to execute on our focus of combining our hardware and biologics technologies, strengthening our position as a comprehensive supplier for spine surgeons and their patients.”

The Irix-A Lumbar Integrated Fusion System consists of an integrated titanium ring, surrounded by an outer PEEK ring and three screws. It is intended for anterior spinal fusion procedures at one or two contiguous levels of the lumbosacral spine (L2-S1 inclusive) in skeletally mature patients for the treatment of degenerative disc disease.

Xtant Medical estimates the US market for standalone anterior lumbar interbody fusion market to be approximately $230 million and growing. The US market for Demineralized Bone Matrix (DBM) is estimated at $410M. The additional Irix-A interbody implants are intended to be available to customers later this year.

About Xtant Medical

Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Investor Contact

CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact

Xtant Medical
Molly Mason
mmason@xtantmedical.com

September 12, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible) (Paris:IMPL) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has received FDA clearance to market the new JAZZ™ Passer.

JAZZ™ Passer comprises new passer instruments and a variation of the JAZZ™ Band braid, the JAZZ™ Passer Band. The latter is 100% compatible with all JAZZ™ platform implant connectors, and replicates the mechanical performances of the innovative JAZZ™ Band braid, highlighted in numerous scientific publications.

JAZZ™ Passer facilitates placing the band around anatomical structures, representing a breakthrough in terms of flexibility and ease of use. This simplified system should drive surgeon adoption of JAZZ™ band technologies.

This comprehensive system was designed in direct response to surgeon feedback. Implanet addresses an ever-expanding list of therapeutic indications, given the characteristics and performance of the JAZZ™ Platform. By effectively covering all degenerative, scoliosis-deformity and trauma-tumor pathologies in adolescents and adults, the Company competes in a market segment estimated at over 2 billion dollars.

Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, says: “This project’s challenge lay in the need to retain our JAZZ™ technology’s proprietary performance characteristics. Our goal was also to develop simple instrumentation that provides the surgeon tactile feel when passing the braid around bony structures. Our valued surgeon advisors confirm that this twofold objective has been achieved, with the combination of the new braid and passers making it even easier to use JAZZ™, notably in the areas of degenerative and complex spine surgery, which account for most spine operations.”

Regarding this new product launch, Nicolas Marin, Implanet’s Chief Marketing Officer, adds: “The JAZZ™ Passer systems enables us to reach a new milestone in the adoption of our technology and the frequency of its use by surgeons. With 20% market share in pediatric deformity surgery in France, we feel that the use of JAZZ™ band technologies has become standard of care and will be part of the therapeutic arsenal of many surgeons in the rest of the world. JAZZ™ Passer represents the most appropriate response to the various problems encountered by spine surgeons that only our technology makes it possible to truly address, illustrated by the conversion of new user surgeons, particularly in the United States.”

Next financial press release: H1 2017 results, on September 19, 2017 after market closes

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ™ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ™ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com. Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013. IMPLANET is listed on Euronext™ Growth market in Paris.

Disclaimer

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1 917 385 21 60
implanet@alphabronze.net

September 12, 2017

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the appointment of Chad Kolean as the Company’s Chief Financial Officer (CFO). In his role, Kolean will oversee Titan’s Finance Team and work to build forward-looking financial preparedness as the Company continues to experience rapid growth following the launch of its nanoLOCK® surface technology.

Prior to joining Titan, Mr. Kolean served as the CFO for Cellectar Biosciences, a life sciences company, where he drove a management restructuring and raised substantial funds resulting in uplisting to the NASDAQ Capital Market. Previously, he served as the CFO at Pioneer Surgical Technologies, providing the organization with leadership strategy, development and execution, Board support, investor relations, budgeting, forecasting, operations and regulatory due diligence. Kolean is a certified public accountant and earned his B.A. in Business Administration from Hope College.

Mr. Kolean commented, “I am thrilled to join the team at Titan Spine, particularly at such an exciting time for the company. We are well-positioned for continued financial growth that capitalizes on a strong first half of 2017. Titan Spine is making substantial progress addressing the key needs for both patients and surgeons, and the company’s growth is a direct reflection of the increased demand surgeons have for the advantages of our nanoLOCK® surface technology.”

Peter Ullrich, Chief Executive Officer of Titan Spine, added, “Chad’s appointment as our CFO validates and reflects our rapid expansion as we continue to disrupt our industry and redefine the role of interbody devices in the fusion process. The growing demand for our technology and our strong sales team has led to significant growth, especially in the first half of this year, and we believe Chad will help drive our continued progress, further benefiting patients at the nano-cellular level to heal faster following spinal fusions.”

Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary nanoLOCK® surface technology, which was launched in the U.S. in October 2016 following FDA clearance in late 2014. The nanoLOCK® surface technology consists of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^2,3,4 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

¹ Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

²Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

³Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

⁴ Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate

Contacts

Company:
Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media:
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com

PLANO, Texas, Sept. 11, 2017 (GLOBE NEWSWIRE) — Noel Goldthwaite, MD, senior surgeon and founding member at SpineCare Medical Group, Inc., is the first physician in northern California to implant Nuvectra’s Algovita^® Spinal Cord Stimulation System, which successfully treated a local injured veteran’s chronic pain and led to his significant reduction in opioid use. The Nuvectra Algovita SCS System is a powerful and versatile spinal cord stimulation system that includes the smallest patient controller on the market. Algovita is FDA approved as a treatment for chronic, intractable pain.

“Following injuries sustained in the line of duty, this particular patient had multiple surgeries that led to unmanaged and intense chronic back pain prior to the placement of Algovita,” Dr. Goldthwaite explains. “The smaller volume paddle lead and ability to steer it using a stylet eased the navigation of significant scar tissue during the procedure. These features allowed me to place the paddle and stimulation exactly where the patient needed it, which helped to alleviate his pain right from the start. Furthermore, after the procedure, the Algovita system differs from other SCS systems in its easy to use keychain patient controller that allows the patient, in conjunction with our medical staff, to customize the amplitude, frequency, and pulse width of the stimulation and toggle between therapy settings. The results have been outstanding! When he initially came to see me, he was severely depressed and in a wheelchair due to his pain. Now he walks into my office upright with a smile on his face and a sparkle in his eye – he’s a totally different person.”

Chronic pain affects over 100 million Americans according to the Institute of Medicine, more than diabetes, cancer, and heart disease combined. Chronic pain is difficult to treat, but one potential treatment option is spinal cord stimulation, or SCS. SCS works by masking or interrupting pain signals as they travel up the spinal cord to the brain. A small, rechargeable battery is implanted under the patient’s skin and connected to thin wires, called leads, which stimulate the nerves sending pain signals. The stimulation “overrides” the pain signals, and instead of feeling pain, patients may feel a tingling sensation known as paresthesia.

Dr. Goldthwaite also discussed the opioid dependency epidemic occurring among our veterans, stating that, “SCS is a powerful non-drug tool that can be used to control pain relief for these patients. Non-drug pain control helps them function, focus, and sleep better and more effectively deal with other related conditions, including PTSD.”

Algovita gave near immediate pain relief to this patient, enabling him to reduce his opioid usage by over 90% in the 6 months since his surgery, which he had become dependent on to keep the pain at bay. Now, he leads what he calls a life of conscious living, being able to enjoy time with his family and help other veterans who have returned from active duty.

The Algovita SCS System was designed to help physicians improve their outcomes and better manage their patients’ pain today and into the future. Algovita offers a number of unique features not available with other systems on the market. With the broadest range of capabilities and fine-tuned control, Algovita provides physicians with the tools to address the individual and changing nature of pain. In addition, Algovita’s leads cover the longest span of the spinal nerves, allowing for additional coverage options as pain moves and changes. As the only stretchable leads on the market, Algovita’s leads are designed to bend and stretch with body movement to help sustain the therapy long-term. Since pain can change throughout the day and with different activities, Algovita also features a small, wireless, key-fob patient controller so stimulation can be easily and discreetly managed.

For more information about Nuvectra and the Algovita Spinal Cord Stimulation system, visit www.nuvectramed.com.

About Dr. Goldthwaite

Dr. Noel Goldthwaite was a founding member of SpineCare Medical Group in 1988. He has performed more than 12,000 spinal operations including more than 350 spinal cord stimulator system implantations and revisions both for the lumbar spine and the cervical spine. He lectures and teaches nationally and internationally. He has a special interest in treating patients who have already had unsuccessful spine surgeries. He understands very well that inadequately treated spine problems, especially failed surgeries with chronic pain, are devastating for the patient, the patient’s family, the patient’s friends, and for society. He is prepared to address all those issues.

Written by Kristin Della Volpe

Research on whether minimally invasive surgery (MIS) for lumbar spine fusion is more advantageous than open surgery has been the topic of much debate. While studies suggest less blood loss and fewer infections with MIS, this approach may take longer and be more technically demanding.

Given the lack of consensus on which approach may be best, patient education and shared decision-making can be complex. New findings suggest that patient preference may be influenced by many factors during consent-taking, as reported in the August issue of The Spine Journal.

“Our study demonstrated that patients change their decisions between MIS and open approaches frequently during the process of consent-taking,” said lead author Hwee Weng Dennis Hey, FRCSEd (Orth), FAMS (Orth), MCI, Consultant, Orthopaedic and Spine Surgery, University Orthopaedics, Hand and Reconstructive Microsurgery Cluster, National University Health System in Singapore. “This is likely due to the different weight each patient gives to the advantages and disadvantages of MIS or open surgery.”

“The most common concerns influencing patients’ final decision are radiation and cosmesis,” Dr. Hey told SpineUniverse. “As a result, consent-taking should be conscientious such that patients are adequately informed. Radiation and cosmesis should be given more emphasis.”

Cross Sectional Study of Patients with Lumbar Spondylolisthesis
The findings are based on a cross-sectional study of 54 patients (mean age, 55.8 years) collected over a 3-month period at a single institution in Singapore. These patients were indicated for transforaminal lumbar interbody fusion (TLIF) for radiographically confirmed lumbar spondylolisthesis. All patients had chronic low back pain and radiculopathy. Patients who had undergone previous spine surgery, had concurrent spine pathologies (eg, tumors, infection, or fractures), or had high-grade spondylolisthesis were excluded from the study.

Standardized Consent-Taking Process
An independent spine specialist interviewed patients using a script that required patients to decide between MIS or open surgery at various points during the consent-taking process. Pictures of the scars from MIS and open surgery as well as information on the potential advantages and disadvantages of both approaches were also provided.

READ THE REST HERE

FT. LAUDERDALE, Fla., Sept. 7, 2017 /PRNewswire/ — Spinal Resources, Inc.^® (SRI) announced that it has received FDA 510(k) clearance for its Swedge™ Pedicle Screw System. This unique system offers multiple benefits, including CoCr and Titanium tulips; double lead and Cortical Cancellous Threads; Polyaxial, Monoaxial, Reduction, and Iliac screws; and MIS (minimally invasive spinal surgery) options. Currently, the Swedge system is cleared for a 5.5mm rod; 4.75mm and 5.0mm rods are pending clearance.

Since 2005, Spinal Resources, Inc. has been developing its groundbreaking technology, which accommodates multiple rods in a single-screw tulip with single-locking cap, and effectively locks the tulip’s angle without the presence of a rod. The FDA’s clearance of the Swedge™ Stabilization System marks the transition of Spinal Resources, Inc. from design and distribution experts into full manufacturers of innovative surgical enhancements. The Swedge system is the company’s first product development effort–and a seminal achievement: SRI’s system holds the tulip’s position while contouring rods in a multi-level scenario. The transition rod features a gradual taper between sections to minimize stress risers. Designed to improve efficiencies within the current and trending hospital environment by reducing inventory and increasing surgical procedure options, which may result in more affordable alternatives for patients, Spinal Resources, Inc.’s versatile, all-in-one Swedge implant system gives clinicians more surgical flexibility in degenerative, deformity, and midline approach surgeries, with a wider range of options to stabilize and conform to varying anatomies. Its MIS capabilities offer patients a smaller incision, with the added benefits of less tissue disturbance, reduced rehab/recovery time, and enhanced outcomes.

A report from GlobalData Healthcare, a UK-based company specializing in providing business data and analytics, indicated the 2017 global spinal fusion market is experiencing steady growth of about 3.4% CAGR (compound annual growth rate). The market is estimated to rise from $7.1 billion in 2016 to approximately $9 billion by 2023. The December 2016 report attributes the increase to degenerative spinal conditions caused by aging and the prevalence of technological advancements in surgeries. To learn more, see https://www.globaldata.com/spinal-fusion-market-approach-9-billion-2023-technology-improves-says-globaldata/.

According to President and Chief Executive Officer Bernard Bedor, no other screw on the market is quite like the Swedge System in capability. “We believe we’ve done something unique with our product,” he said. “We’ve taken three different rod sizes, put them into one effective tulip, and can lock them with a one-step locking cap. The Swedge System provides surgeons with greater versatility in the pre-planning and inter-operative stages, effectively reducing the surgical ‘fiddle factor’ thanks to its convenient standard and transition rods and screws in a variety of diameters and lengths. Our focus at SRI is to be problem-solvers for patients by supporting surgeons and hospitals in their important work with fewer instruments and a smarter system that shorten operating room time and lower costs.”

With the ownership of four (4) patents (and two more under consideration), this FDA clearance, and several other promising products in its pipeline, SRI is standing out as a strong contender in the design and manufacture of innovative solutions that enhance surgical procedures. The company is exploring full commercialization via strategic partnership, license, and/or private/corporate funding. For more information, contact our media and investors relations specialist: Ms. Melanie Raskin – melanie.raskin@aktaPD.com

Intended Use
The Swedge™ Pedicle Screw Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis, and failed previous fusion.

It is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: DDD (degenerative disc disease), trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

About Spinal Resources, Inc.^® (SRI)
Founded in 2005, Spinal Resources, Inc.^®is a Ft. Lauderdale, Florida-based spinal medical device company that supports cost-effective patient care with innovative mechanical and biomechanical products to alleviate pain, shorten recovery time, restore health, and extend quality of life. SRI has engineered a unique line of patented spinal and cervical fixation systems with stem growth factors for the surgical repair and reconstruction of debilitating spinal conditions. For more information, visit spinalresourcesinc.com.

Media Contact:
Melanie Raskin
175102@email4pr.com

SOURCE Spinal Resources, Inc.(R)

NEW YORK, NY (PRWEB) SEPTEMBER 06, 2017

Orthopedic spine surgeon Dr. Alexios Apazidis completed a successful C3-4 anterior cervical discectomy and fusion at Fifth Avenue Surgery Center in New York City in August. As a result of a herniated disc, the female patient was experiencing radiculopathy symptoms and neck pain. After failing conservative treatment options including physical therapy, pain medications and epidural injections – she opted for a surgical approach.

Preferring a zero profile implant option as a result of existing hardware at the adjacent level, Dr. Apazidis chose to utilize the spinal device company’s Less Exposure Surgery Technology, A-CIFT SoloFuse – designed to leverage the familiarity of existing techniques while providing an alternative to cumbersome plating for one-level procedures.

Dr. Apazidis attested to the advantages of using the A-CIFT SoloFuse technology during this procedure. “The system is very easy to use. The instrumentation is low profile and well thought out, allowing you to expedite the procedure,” said Dr. Apazidis.

“This was a perfect case for A-CIFT SoloFuse because it was adjacent to a two-level fusion with a plate that was extremely proximal to the adjacent level and likely led to the degeneration of that level,” he explained. “The ability to have a low profile implant around a bulky plate allowed us to avoid the need to extend the dissection and spend time removing the plate. The trajectory of the screws allows us to achieve excellent fixation and maintain the position of the implant as it was placed intraoperatively.”

The simplicity of the A-CIFT SoloFuse design makes for a straightforward implantation that minimizes tissue disruption. This was SpineFrontier technology’s debut at the Fifth Avenue Surgery Center.

About Dr. Apazidis

Dr. Apazidis is affiliated with multiple hospitals in the New York area, including NYU Winthrop Hospital and Nassau University Medical Center. He received his medical degree from Boston University School of Medicine and is a member of the American Academy of Orthopedic Surgeons, North American Spine Society, Medical Society of the State of New York and Suffolk County Medical Society. He is certified board eligible by the American Board of Orthopedic Surgeons.

About SpineFrontier® Inc.
SpineFrontier Inc. is a growing medical technology company that designs, develops and markets both implants and instruments for spine surgery based on the Less Exposure Surgery (LES®) Philosophy. These technologies are designed to allow for outpatient surgery due to minimal disruption of normal tissues. SpineFrontier is headquartered in Malden, Mass. It is a KICVentures portfolio company and the leader in LES® technologies and instruments.

About Less Exposure Surgery
Less Exposure Surgery (LES®) is based on a new philosophy of performing surgery. LES® is less invasive than MIS. By developing improved technologies and techniques tailored for pinpointing a problem and fixing it without collateral damage, LES® minimizes tissue disruption.

About A-CIFT SoloFuse
A-CIFT SoloFuse-P Standalone Less Exposure Surgery System was intentionally designed to leverage the familiarity of existing techniques while providing an alternative to cumbersome plating for one-level procedures. Its simplicity of design makes for a straightforward implantation that minimizes tissue disruption.

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