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Spine

Nexxt Spine: Taking Action to Reduce Post-Operative Surgical Infection

October 18, 2016 OrthoSpineNews

Oct 18, 2016 – NOBLESVILLE, Ind. –(BUSINESS WIRE)

Nexxt Spine, LLC, a privately held medical device company dedicated to increasing procedural efficiency and clinical outcomes for patients with debilitating spinal conditions, further demonstrates the company’s on-going commitment toward reducing post-operative surgical infections with the addition of an ISO Class 10,000 (International Standards Organization) Certified Cleanroom for pre-packaging sterile spinal implants within their manufacturing and corporate headquarters located in Noblesville, IN.

Postoperative spine infections have been reported to occur in 1 to 15% of patients after spine surgery. A study of 105 consecutive spine surgeries published in The Spine Journaldemonstrated that spinal implants sterilized following a validated hospital protocol were tested and found to have a contamination rate of 16.7%1.

“Patient safety is our #1 priority. While multiple factors could contribute to post-operative infection, the authors published data on spinal implants previously assumed sterile and later found to be contaminated,” reports Dr. Robert Wertz, V.P. New Product Development at Nexxt Spine. “We have recently completed certification and validation of our ISO 7, Class 10,000 Cleanroom and will launch our pre-packaged sterile implant initiative parallel to the anticipated FDA clearance of Nexxt Matrixx, a 3-D printed, porous, titanium line of intervertebral spacers used in spine fusion procedures.”

According to Nexxt Spine’s President, Andy Elsbury, “Pre-packaged sterile implants do not require disinfection and steam sterilization prior to use. Implants are individually wrapped in a peel pack tray and sterilized using electron beam (E-beam) radiation. Implant packaging is opened literally seconds prior to implantation. Unlike the reprocessed spinal implants referenced in The Spine Journal study, the risk for implant contamination is virtually non-existent.”

Nexxt Spine will be exhibiting at the 31st Annual North American Spine Society (NASS) Meeting, October 26-29, 2016, in Boston, MA. To arrange an introductory meeting with a member of Nexxt Spine’s Management Team please contact info@nexxtspine.com.

About Nexxt Spine

Nexxt Spine, LLC is a privately held medical device manufacturer dedicated to increasing procedural efficiency and patient outcomes through development of innovative products, manufactured on the most technologically advanced platforms, and utilizing irreproachable quality standards to treat painful and debilitating spinal pathologies.

Additional information is available online at www.nexxtspine.com.

Reference:

1. Bible, J. E., O’Neill, K. R., Crosby, C. G., Schoenecker, J. G., McGirt, M. J., & Devin, C. J. (2013). Implant contamination during spine surgery. The Spine Journal, 13(6), 637–640. doi:10.1016/j.spinee.2012.11.053

Nexxt Spine, LLC
Sarah Caito Koch, 317-436-7801
Scaito@NexxtSpine.com

Copyright Business Wire 2016

This article was originally distributed via Business Wire. Business Wire, Frankly and this Site make no warranties or representations in connection therewith. If you are affiliated with this page and would like it removed please contact pressreleases@franklyinc.com

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Spine

Spineology Completes Limited Release for Elite™ Expandable Interbody Fusion System

October 17, 2016 OrthoSpineNews

October 14, 2016

MINNEAPOLIS & ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology is excited to announce the successful completion of the Elite™ Expandable Interbody Fusion System limited release. The Elite Expanding Interbody Implant is inserted into the disc space in a contracted minimal height to minimize dissection and neural retraction. It is then incrementally expanded to restore the anatomical height of the space in order to maximize fit and potentially provide indirect neural decompression.

“During the Elite limited release, we took close note of surgeon feedback and what they desired to best treat their patients,” said John Booth, CEO of Spineology. “Observing the surgeon reactions during the limited release and implementing requested enhancements strengthens our belief that Elite will be an exceptional, well received, interbody option in the growing expandable implant market.”

Dr. Mark Grubb of Cleveland, Ohio said, “The ability to deliver an Implant into the disc space at a minimal height in order to limit retraction and reliably control expansion is key in treating patients with spinal disorders. Elite’s instrumentation allows controlled implant delivery and precise height expansion, resulting in an overall effective system.”

Dr. Harel Deutsch of Chicago expressed, “The broad selection of implant heights and lordotic options provide exceptional flexibility and the ability to treat a large range of patients. Additionally, the distraction capabilities and ability to lock the implant at any height during expansion is a feature that further enhances device fit and restoration potential.”

About Spineology

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 Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

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Spine

Zyga Releases 12-month Fusion and Clinical Results of Sacroiliac Joint Fusion with Decortication

October 17, 2016 OrthoSpineNews

MINNETONKA, Minn., Oct. 17, 2016 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today released 12-month fusion and clinical results for patients receiving SImmetry® Sacroiliac (SI) Joint Fusion with decortication. Study results were presented on Saturday morning at the 2016 Society for Minimally Invasive Spine Surgery (SMISS) Annual Meeting by Dr. William Cross, an orthopedic trauma surgeon at the Mayo Clinic in Rochester, Minn.

“Minimally Invasive SI joint fusion has been established as an effective treatment for certain patients suffering from SI joint disorders, but many technologies available today don’t follow the accepted orthopedic principles that lead to successful long-term fusion,” said Dr. Cross, the lead author and presenter at the SMISS scientific meeting. “For me, it’s common sense that SI joint fusion should include decortication and bone grafting to achieve long-term success. The results of this study provide compelling evidence that decortication and bone grafting may contribute to earlier fusion, and that the procedure provides significant pain relief at one year post-op.”

This prospective, multi-center study enrolled 19 patients at three institutions, who underwent a CT scan 12 and 24 months after receiving minimally invasive SI joint fusion with decortication and bone grafting. CT images were reviewed by a non-biased, independent radiology core laboratory to assess fusion in relation to the joint and the area of decortication. At 12 months, fusion was reported in 74% of patients, and back pain decreased from 7.9 to 2.2 (72%). Of patients in whom fusion was reported, 86% showed fusion in the area of decortication. Freedom from device- or procedure-related adverse events through 12 months was 100%. 24-month results for the study are expected in early 2017.

The SImmetry Sacroiliac Joint Fusion System is a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The Company will next exhibit at the 2016 North American Spine Society (NASS) meeting inBoston, Mass., October 26 – 28.

The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adultsi. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac jointii.

About Zyga Technology, Inc.

Zyga Technology, Inc. is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of underserved conditions of the spine. In addition to marketing the SImmetry System, the company is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, an investigational, non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain. For more information, visit zyga.com.

i Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
ii Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

CONTACT:
Erin Morrison
Tel 952 698 9956
emorrison@zyga.com

Photo – http://photos.prnewswire.com/prnh/20150323/183902
Logo – http://photos.prnewswire.com/prnh/20110118/CG30384LOGO

SOURCE Zyga Technology, Inc.

Related Links

www.zyga.com

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Spine

EOI Announces that Dr. Roybal will Present his Experience with the FLXfit™ 3D Expandable Cage at SMISS

October 13, 2016 OrthoSpineNews

OR AKIVA, Israel, October 13, 2016 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is proud to announce that Dr. Raphael Roybal from The Spine Institute at Chatham Orthopaedics, Savannah, GA., will present his clinical experience with the FLXfit™, the world’s only articulated and expandable cage with in-situ lordosis restoration, at the SMISS, Las Vegas (Oct 13-16, 2016).

Dr. Roybal, who has already implanted tens of FLXfit™ cages, “I wanted to compare lordosis correction between fixed and expandable lordotic cages using MIS TLIF approach”. And indeed, he says that “The results of an initial series with 6 months follow-up show that the use of the FLXfit™ expandable cage demonstrated increased correction of the sagittal alignment post-operatively compared to a fixed angle banana cage.” In Dr. Roybal’s eyes, “This is clearly understood by the configuration of the cage covering a wider footprint area with a more controlled expansion of the lordosis angle conforming to the unique patient’s anatomy. Additionally, the procedure is faster, easier and gentler to the patient due to the expansion mechanism.”

Dr. Roybal added, “A statistically significant improvement was noted in the group treated with the FLXfit cage vs. the fixed banana cage in all heights and lordosis measurements (p ≤0.02) and that maintenance of correction without subsidence in both groups was noted at 6 months.” He concludes that “The major advantage of the FLXfit™ over existing solutions is its ability to combine a big footprint, optimal anterior column support and significant bone graft volume while preserving the patient’s anatomy through a posterior, MIS, TLIF approach.”

Ofer Bokobza, CEO of Expanding Orthopedics, said that “We are very proud of Dr. Roybal’s achievement and honored by the selection to present at the renowned SMISS meeting.” He explains that “Dr. Roybal’s clinical results demonstrate the FLXfit™ ability to restore lordosis while maintaining it over time.” Ofer concludes that “We see a great momentum in the US market with more surgeons adopting the FLXfit™ as their preferred treatment option for their patients.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. (EOI) is a medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is backed by prominent spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info

David Elkaïm, VP Marketing and Sales
E-mail: david@xortho.com 
Phone: +1-(347)321-96-83

SOURCE Expanding Orthopedics Inc. (EOI)

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Spine

Medovex Corporation Reports Successful Demonstration of Expanding EMEA Business at EuroSpine 2016, Berlin, Germany

October 13, 2016 OrthoSpineNews

ATLANTA, GA–(Marketwired – Oct 13, 2016) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that the Company successfully exhibited its’ DenerveX™ System during EuroSpine 2016 Tradeshow last week in Berlin, Germany.

As part of the product exhibition, Medovex highlighted its innovative DenerveX™ System, a minimally invasive surgical (MIS) procedure pioneered by Medovex that was built around the denervation of the posterior capsulectomy of the Facet Joint using our patented Rotablation™ technology which is “A significant paradigm shift in the treatment of Facet Joint pain.”

Patrick Kullmann, President and COO for Medovex, stated, “We consider EuroSpine 2016 in Berlin our ‘pre-launch’ meeting leading up to what is expected to be an eventual formal CE Marking. In particular, we were very pleased to see visiting surgeons and distributors from more than 25 countries, and from all continents, at our booth, along with existing and new potential distributors visiting with us.”

Kullmann continued, “Importantly, we conducted meetings and demonstrations with at least six potentially strategic companies that could open the door to future collaboration for distribution, investment, co-future development of future generations of the technology or even potential acquisition. Many of the spine surgeons and pain relief physicians visiting the booth stated that the DenerveX Design is very elegant, and represents a very new and creative approach in treating pain associated with the Facet Joint Syndrome. Their clear appreciation for our different approach in performing a new procedure by way of a posterior capsulectomy of the facet joint, compared to the less effective standard radio frequency ablation (Rhizotomy), gives us cause for continued cautious optimism going forward.”

During EuroSpine 2016, Medovex also announced the official opening of the Company’s European Distribution Center in Berlin.

The Center will serve as Medovex’s European distribution service headquarters and function as the commercial hub for all European distributors, as well as other customer and technical support functions. The international operations center in Atlanta, GA (USA) will remain the Company’s global operational headquarters.

Manfred Sablowski, Senior Vice President of Global Sales & Marketing, added, “The opening of the European distribution service center is an important milestone for Medovex and a key inflection point for our Company’s strategy to grow our business in Europe, Middle Eastern and Africa regions. In the past months, we have additionally expanded our footprint to include all of Scandinavia and Israel. Our future goal is to increase our world-class EMEA distribution in other key countries. With the recent appointment of Juan Davila as Director Sales & Marketing for Latin America, having extensive experience in this market, we expect to continue to execute our go to market strategy.”

The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options. It consists of two procedures combined into one device and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system. DenerveX is not yet commercially available.

DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

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Spine

Titan Spine Initiates Full U.S. Launch of New nanoLOCK® Surface Technology

October 13, 2016 OrthoSpineNews

October 13, 2016

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it has expanded the distribution of its line of Endoskeleton® titanium implants featuring the company’s new proprietary nanoLOCK® surface technology nationwide. The full U.S. launch follows the successful alpha introduction of the nanoLOCK® technology initiated recently in a limited number of sites. The Company has achieved sales of nanoLOCK® implants in 14 hospitals in 8 states since its introduction and is in the process of signing contracts with several large hospital systems.

The nanoLOCK® surface technology, which is manufactured through a proprietary subtractive process, has received two differentiated government agency designations that highlight its uniqueness within the interbody fusion device market. In late 2014, Titan Spine added an additional U.S. Food and Drug Administration (FDA) clearance for “nano-textured surface” to the product line’s initial 510(k). In October 2016, nanoLOCK® was granted its own new technology category and code, formally known as an “ICD-10pcs New Technology Section X Code,” by the U.S. Centers for Medicare & Medicaid Services (CMS).

Steve Cichy, Vice President of Sales for Titan Spine, said, “The full launch of nanoLOCK® will add to Titan Spine’s continued sales growth, highlighted by our 51% sales increase in 2015 compared to prior year. The interest in nanoLOCK® has been incredibly strong and has challenged us to keep up with demand. We have generated a strong start and anticipate rapid surgeon adoption of nanoLOCK®as we ramp up the full U.S. launch and showcase the technology at the upcoming North American Spine Society (NASS) Annual Meeting in Boston.”

Kevin Gemas, President of Titan Spine, commented, “The full U.S. launch of our nanoLOCK® surface technology comes at an optimal time as the interbody market is rapidly shifting toward titanium surface-enhanced implants. It represents a major milestone for Titan Spine and is the culmination of years of preparation through scientific study, manufacturing validation, IP protection, and unique regulatory clearances through collaboration with the FDA and CMS. This effort resulted in nanoLOCK® being the only nano-cleared interbody device on the market and is the only interbody device that has access to the recently-created new technology ICD-10 code for a nanotextured surface on an interbody fusion device. Through our extensive research, which has been published in several peer-reviewed journals, the industry is now beginning to understand the importance of our very specific titanium nano-architecture in its ability to promote the generation of osteogenic and angiogenic growth factors necessary for bone growth and fusion compared to other surfaces.1 And finally, we appointed a general counsel to protect our legal interests and ensure that our extensive IP portfolio and proprietary scientific data are fully defended. We have taken all of these vital steps to ensure that our nanoLOCK® surface is truly differentiated in a market that is quickly becoming crowded with imitators. We are very pleased with its launch thus far and look forward to it benefiting more surgeons and patients moving forward.”

Titan Spine offers a full line of Endoskeleton® devices that feature Titan Spine’s proprietary nanoLOCK® surface technology, consisting 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.1,2 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.

2 Olivares-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.

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

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NFL players get back in the game after upper spine surgery

October 10, 2016 OrthoSpineNews

October 4, 2016 – Wolters Kluwer Health: Lippincott Williams and Wilkins

The majority of U.S. National Football League (NFL) players who undergo surgery for a herniated disc in the upper (cervical) spine are able to resume their careers and perform at a high level, suggests a study in Spine, published by Wolters Kluwer.

Even players with “upper-level” cervical disc herniation (CDH) have a high return rate and can return to play with similar performance outcomes compared to their “lower-level” counterparts, according to the analysis by Dr. Harry T. Mai of the Department of Orthopaedic surgery at the Northwestern Feinberg School of Medicine, Chicago, and colleagues. The results may help guide decisions about surgery and the likelihood of returning to competition for players with these career-threatening injuries.

Good Chance of Continuing NFL Career after CDH Surgery

The researchers identified 53 NFL players who underwent surgery for a herniated disc in the cervical spine between 1979 and 2013. Forty players had confirmed data on the level of the disc injury: 15 had “upper level” CDH (involving the uppermost vertebrae of the neck) while 25 had “lower level” injuries. Forty-five percent of the players were defensive backs and linebackers.

Rates of successful return to play after CDH surgery were analyzed. Most players — 67 percent of those with upper-level CDH and 72 percent with lower-level injuries — were able to return to play after surgery and rehabilitation, with no significant differences between the two groups. In both groups, recovery time was about nine months. On average, players continued playing for about 44 games and three years after CDH surgery.

To get an idea of how well each athlete played after returning from surgery, the researchers used a “Performance Score” based on NFL game statistics. Scores were not significantly different between groups, suggesting that athletes with upper-level CDH performed as well as those with lower-level injuries.

In 34 players, surgery consisted of spinal fusion (a procedure called anterior cervical discectomy and fusion, or ACDF). Four players developed degenerative disease at an adjacent vertebral level, requiring additional surgery. While this is a serious complication, it appeared to be no more frequent than in non-athletes undergoing ACDF.

The other six players underwent a less invasive procedure called foraminotomy which attempts to take pressure off the spinal nerves by decompression. Half of these patients later required additional ACDF surgery — a higher rate than observed in non-athletes. “It is possible that the rigors and activity required by a professional athlete, specifically axial collision forces, make them poor candidates for a non-fusion procedure,” Dr. Mai comments.

Cervical disc herniation is common among NFL and other elite athletes in contact sports and appears to be more common in upper level discs than the general population. While CDH also occurs in non-athletes, it is typically diagnosed in middle age and usually is not related to traumatic injury. For football players, the expected outcomes after CDH surgery — including the player’s ability to continue to compete at a high level — are unclear. That’s especially true for patients with upper-level CDH injuries.

The results suggest that most NFL players who undergo cervical spinal surgeries for CDH are able to resume their careers. Return to play, and level of performance after returning to competition, appear similar for players with upper-level versus lower-level cervical injuries. The authors note some important limitations of the study data, including potential “selection bias toward more prominent athletes.”

Gaining a better understanding of cervical spine injuries in elite athletes may help in developing better-tailored treatment approaches for this unique group of patients, Dr. Mai and colleagues believe. They conclude, “Further study is required to help surgeons definitively determine the individualized course of treatment for an NFL player dependent on pathology, position, and patient wishes.”

Story Source:

Materials provided by Wolters Kluwer Health: Lippincott Williams and Wilkins. Note: Content may be edited for style and length.

Journal Reference:

  1. Harry T. Mai, Robert J. Burgmeier, Sean M. Mitchell, Andrew C. Hecht, Joseph C. Maroon, Gordon W. Nuber, Wellington K. Hsu. Does the Level of Cervical Disc Herniation Surgery Affect Performance-Based Outcomes in National Football League Athletes? SPINE, 2016; 1 DOI:10.1097/BRS.0000000000001868

  2. Cite This Page:

    Wolters Kluwer Health: Lippincott Williams and Wilkins. “NFL players get back in the game after upper spine surgery.” ScienceDaily. ScienceDaily, 4 October 2016. <www.sciencedaily.com/releases/2016/10/161004111655.htm>.
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Spine

Polymers enable lighter medical devices

October 7, 2016 OrthoSpineNews

October 5, 2016

Alpharetta, Georgia – Solvay’s medical grade KetaSpire polyetheretherketone (PEEK) and AvaSpire polyaryletherketone (PAEK) polymers enabled medical device pioneer, Shanghai Reach Medical Instrument Co., to develop a lighter, more ergonomic and highly cost-effective kit of reusable instruments for spinal surgeries.

“For decades, metal was the material of choice for medical instruments because conventional plastics could not deliver metal’s combination of high modulus, strong chemical resistance and compatibility with stringent sterilization methods,” says Xiaomin Huang, general manager of Shanghai Reach. “Today, Solvay’s broad range of specialty polymers is changing that reality – not only by offering metal-like performance, but by also enabling the fabrication of more complex and integrated parts through cost-effective injection molding.”

Shanghai Reach’s innovative kit includes six reusable instruments:  one rod bender, two pairs of distraction and compression pliers, and three awls. For the rod bender, the medical device-maker specified KetaSpire KT-880 CF 30 PEEK, a 30% carbon fiber-reinforced resin that delivers the high strength and stiffness necessary to bend implantable 5.5mm to 6.0mm titanium rods. For the pliers and awls, Shanghai Reach chose AvaSpire AV 651 GF 50 PAEK, a 50% glass fiber-reinforced resin offering a cost-effective balance of strength, stiffness and dimensional stability.

Typically, these parts would be made from stainless steel. But Shanghai Reach’s goal was to reduce instrument weight by up to 70% for improved ergonomics, yet not compromise on mechanical properties or sterilizability. In addition to lightweight strength and stiffness, Solvay’s two biocompatible polymers offer strong resistance to fatigue and are compatible with sterilization methods based on stringent chemicals, steam and even gamma radiation.

“Shanghai Reach’s innovative new kit highlights the ground-breaking value that Solvay’s advanced polymers are injecting into a healthcare market once dominated by metal,” states Jeff Hrivnak, global business development manager for healthcare at Solvay’s Specialty Polymers Business Unit. “We expect this trend to continue as we team with industry pioneers like Shanghai Reach to explore new possibilities for replacing metal medical instruments with more cost-effective, ergonomic instruments made from high-performance polymers.”

Solvay Specialty Polymers’ experience as a reliable materials supplier in the healthcare field spans more than 25 years. The company is a leading manufacturer of healthcare plastics, offering a broad range of high-performance, medical-grade plastics for orthopedics, sterilization cases and trays, medical and dental devices, as well as filtration media and housings for hemodialysis and water purification membranes. Solvay also offers a family of Solviva Biomaterials for use in a range of implantable devices.

Source: Solvay Specialty Polymers

 

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Spine

Benvenue Medical Presents Clinical Evidence on Luna and Kiva Systems at SMISS Annual Forum ‘16

October 6, 2016 OrthoSpineNews

October 06, 2016

SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, today announced key clinical data presentations and company events for the Luna 3D Multi-Expandable Interbody Fusion System and Kiva VCF Treatment System at the Society of Minimally Invasive Spine Surgery (SMISS) Annual Forum ‘16 Oct. 13-15 in Las Vegas.

Data Presentations

  • “Multi-Expandable Cages for Minimally Invasive Posterior/Transforaminal Lumbar (P/TLIF) Interbody Fusion – A Preliminary Report” (Paper #38) will be presented by Dr. Jeffrey Coe of the Silicon Valley Spine Institute (Campbell, California) on Saturday, Oct. 15 at 11:17 a.m. The podium presentation will highlight early experience and encouraging outcomes with the Luna Interbody Fusion System in minimally invasive P/TLIF, including absence of nerve retraction injuries and restoration of disc height, segmental lordosis, and foraminal height, along with lack of subsidence and maintenance of sagittal correction.
  • “Serious Adverse Events Associated with Re-admission through One Year after Two Different Approaches to Vertebral Augmentation” (Paper #27) will be presented by Dr. Douglas Beall of Clinical Radiology of Oklahoma (Edmond, Oklahoma) on Friday, Oct. 14 at 11:45 a.m. The podium presentation will review serious adverse events requiring unplanned re-admission for patients who had vertebral augmentation using the Kiva VCF Treatment System as compared to balloon kyphoplasty.
  • “Superior Articular Process Interbody Reconstruction: Feasibility and Short Term Clinical Outcomes of a Novel Posterior Lumbar Interbody Fusion Approach” (Poster #22) will be moderated by Dr. Joshua Ammerman of Washington Neurosurgical Associates (Washington, DC). The poster highlights Dr. Ammerman’s novel posterior minimally invasive approach to safely access the lumbar disc without intrusion into the spinal canal by use of the Luna 3D interbody cage to restore disc height as a means to achieve indirect canal and foraminal decompression.
  • “Community Practice Experience with Subsequent Vertebral Compression Fractures during the Year after Vertebral Augmentation using an Expandable Implant” (Poster # 17) will be moderated by Dr. Ryon Hennessy of Orthopedic Specialists (Elmhurst, Illinois). The poster reviews the rate of subsequent vertebral compression fractures in the year following vertebral augmentation with the Kiva VCF Treatment System.

“At SMISS 2016, we will be presenting much anticipated early clinical experience with our Luna 3D Interbody Fusion System, highlighting the benefits of the multi-expandable implant,” said Robert K. Weigle, CEO of Benvenue Medical. “We will also be presenting important data on our Kiva VCF Treatment System showing its positive impact on potentially reducing subsequent fractures and other adverse events compared to balloon kyphoplasty.”

Benvenue will also exhibit at booth #100 and sponsor the “Elevating Surgical Outcomes: Sagittal Correction and Height Restoration with Expandable TLIF and VCF Implants” Technology Workshop presented by Dr. Coe on Saturday, Oct. 15 at 7:30 a.m.

About the Luna 3D Interbody Fusion System

The Luna 3D Interbody Fusion System is designed to provide one of the largest yet least invasive devices for posterior lumbar interbody spinal fusion. Cleared by the U.S. Food and Drug Administration in November 2014, the Luna 3D System is comprised of a PEEK implant designed to expand in multiple dimensions within the disc space, first in footprint and secondarily in height, allowing surgeons to effectively restore height via a posterior approach while providing the stability of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 3D Implant is delivered through a small diameter cannula into the disc space. After expanding its footprint, it is then expanded in height with the insertion of a middle section. When the cannula is removed, bone graft is placed in the middle of the implant and the implant is locked in place with a locking wire.

About the Kiva VCF Treatment System

The Kiva VCF Treatment System provides a new implant-based approach to vertebral augmentation in the treatment of painful VCFs. Kiva was recently launched in the U.S. and it is commercially available in Europe. Kiva has been shown, in at least three comparative studies with a total of more than 500 patients, to meet or exceed the performance of balloon kyphoplasty, the standard of care. Kiva is indicated for the reduction and treatment of spine fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

About Benvenue Medical, Inc.

Founded in 2004, Benvenue Medical, Inc. provides next generation minimally invasive systems for spine repair that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by DeNovo Ventures, Domain Associates, Esquilime Partners, InterWest Partners, Technology Partners and Versant Ventures. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $9 billion globally. For more information, visit www.benvenuemedical.com.

Contacts

Merryman Communications
Betsy Merryman, 310-560-8176
betsy@merrymancommunications.com

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Spine

ChoiceSpine appoints Christy Cote as Vice President of Biologics

October 5, 2016 OrthoSpineNews

KNOXVILLE, TN, October 5, 2016 – ChoiceSpine, a Knoxville, TN based spinal implant company, today announced it has appointed Christy Cote as Vice President of Biologics. She is a business leader with 14+ years’ experience in stem cell technology, surgical implants, and regenerative therapies. She’s had an award winning sales career and brings with her technical expertise and strategic development focused on developing a Biologics portfolio for ChoiceSpine. Prior to joining, Christy served as Vice President of Biologics of Amendia and Biologics Regional Vice President of Orthofix. She has a Bachelor of Science in Applied Biology with focus in Microbiology from The Georgia Institute of Technology.

 

If you would like more information about ChoiceSpine’s biologics offering please email info@choicespine.com

About ChoiceSpine
ChoiceSpine is a privately held spine company located in Knoxville, TN, and prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon focused systems that are designed to be safe, efficient, and easy-to-use.

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