Screws that fit the body’s notches

Posted On November 16, 2016 By OrthoSpineNews In Extremities, Sports Medicine /

Complex bone fractures are often set with titanium or steel screws and plates. However, if these remain in the body for some time, they can cause health problems. A new bioceramic screw nail has the capacity of replacing the currently used metal components. It can be easily introduced into bone and does not have to be removed. Fraunhofer researchers are presenting the screw nail from November 14-17 at the MEDICA trade fair in Düsseldorf.

The beginning of the ski season is always a hectic period for alpine emergency wards. After treatment, some patients end up with metal components in their bodies, as complex bone fractures are usually set with titanium or steel screws and plates. These must be surgically removed later, at considerable expense and discomfort to the patient. If the screws remain in the body, they can trigger inflammation or allergies in sensitive patients. However, these complaints could soon become history, as researchers from the Fraunhofer Institute for Manufacturing Technology and Advanced Materials IFAM have partnered with the university hospitals of Giessen-Marburg and Bonn and the University of Bremen to develop a bioceramic implant screw nail. The new biomedical component, dubbed a “scrail,” is made of calcium phosphate, which greatly resembles the composition of bone material.

Reduced risk of injury to tendons and bones

The project was supported by the German Federal Ministry for Education and Research with a million-euro grant. According to Dr. Sebastian Hein from Fraunhofer IFAM, important project tasks included designing the screw nail according to ceramic requirements and hardening it. In contrast to previous medical screws made from titanium or polymer, the new screw nail will not be screwed into the bone, but rather carefully hammered in. For this reason, researchers have developed a specially shaped thread for the screw nail that allows it to be implemented with a minimum of rotations and reduces the risk of damage to tendons and bones.

In contrast to metal components, the ceramic screw nail integrates into the bone and does not have to be removed, since the two most used bioceramic materials — calcium phosphate and hydroxyapatite — are very similar to bone material. This is a distinct advantage over polymer screws, which disintegrate in the body. Degradation products from polymer screws can cause inflammation. Additionally, after the disintegration of the screws, cavities can form in bones, rendering them unstable and more prone to breaking. Ceramic-based screw nails do not disintegrate, but instead bond with the bone. Ideally, they can even accelerate bone growth, says Hein.

Patient-specific implants

The greatest challenge for the development team at Fraunhofer IFAM and Bremen University was attaining the maximum strength of the material, since ceramics are fairly breakable. With the help of injection molding technology, researchers pour hydroxyapatite powder into screw nail molds and heat them. Using the right process para-meters delivers components with optimized stability. The procedure is particularly suited to mass production, as it is inexpensive and allows for flexible mold design. However, hydroxyapatite powder can also be used in conjunction with 3D printers, thus enabling the production of patient-specific implants.

Hein anticipates that the screw nail will soon be ready to use in operations, as calcium phosphate has already been tested for biocompatibility and has been in use as a material in medical applications for several years. Furthermore, medical tests in sheep have shown that the screw nail could be inserted much more quickly and precisely than standard screws, which was “an effect totally unexpected from our side,” says Hein. As a result, the operation time is shortened and the patient is under anesthetic for less time.

Story Source:

Materials provided by Fraunhofer-Gesellschaft. Note: Content may be edited for style and length.

SpineGuard® DSG™ Screw Recognized as One of the Best New Spine Technologies for 2016

Posted On November 16, 2016 By OrthoSpineNews In Spine /

November 16, 2016

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–SpineGuard (FR0011464452 – ALSGD) announced today that it has received an award from Orthopedics this Week, one of the most widely read publications in the Orthopedics industry, recognizing SpineGuard’s innovative DSG™ (Dynamic Surgical Guidance) Screw as one of the BEST new spine care technologies for 2016. The award was received during the 31^st annual meeting of the North American Spine Society (NASS) in Boston.

The DSG™ Screw is a pedicle screw with a unique combination of a bipolar sensor with a pedicle screw—in just one device. The technology gives surgeons real-time guidance and the ability to insert the screw directly into a vertebra without drilling a pilot hole.

The DSG™ sensor differentiates various tissue types based on an analysis of the local electrical conductivity (cancellous bone, cortical bone, blood and soft tissues). Real-time feedback informs the surgeon of changes in tissue type by changes in the pitch and cadence of an audio signal and a flashing LED light. This in turn alerts the surgeon of potential pedicular or vertebral breaches during pedicle screw placement.

Moreover, the use of the DSG™ screw in MIS (Minimally Invasive Spine surgery) obviates the need for a k-wire. The outcome is a single-step pedicle screw insertion with an unprecedented degree of accuracy along with the added benefits of the potential for reduced radiation exposure and streamlined surgical steps, with resulting time- and cost-savings.

The US FDA clearance process for the DSG™ Screw is in progress. The FDA dossier was submitted in conjunction with Zavation, a spinal implant company that SpineGuard has partnered with to license and co-develop a DSG-enabled Zavation SmartScrew. Once cleared, Zavation will market and sell the first DSG-enabled screw in the USA.

Pierre Jérôme, Co-founder and CEO of SpineGuard, concluded: “This award is a great recognition for the SpineGuard R&D and marketing teams, the co-inventors of the DSG™ technology, the surgeons involved in the product design, as well as NeuroFrance and Zavation, our pedicle screw partners. Given the quality of the panel who made the selection, this award is very encouraging for the future adoption of our DSG™ integration system.”

A DSG™-enabled SmartScrew co-developed with Neuro France Implants (La ville-aux-Clercs, France) is currently in alpha launch in Europe with five surgeons having started to use the system.

More information on the DSG™ technology, its new applications and surgeons’ testimonials here.

Recent events:

SpineGuard reports 50,000 spine procedures performed using its family of PediGuard devices for accurate pedicle screw placement. The PediGuard product line includes the PediGuard Straight, PediGuard Curved, PediGuard Cannulated, and PediGuard Threaded.

Latest news release: SpineGuard^® expands “PediGuard^®” franchise, will launch “PediGuard Threaded” drilling device at North American Spine Society (NASS) annual meeting, October 19, 2016

Next financial press release: 2016 full year revenue, January 5, 2017

About SpineGuard^®
Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard^®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. 50,000 surgical procedures have been performed worldwide with PediGuard. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. In 2015, SpineGuard started to expand the applications of DSG into pedicle screws through partnerships with innovative surgical companies in France and the US. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Pierre Jérôme, +33 (0)1 45 18 45 19
Chief Executive Officer
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent, +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

Xtant Medical Receives FDA Clearance to Use Allografts in the Stand-Alone Irix-C™ Cervical Cage

Posted On November 16, 2016 By OrthoSpineNews In Regulatory, Spine /

BELGRADE, Mont., Nov. 15, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT: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 the Irix-C cervical cage for use with autograft and/or allograft and the expansion of the range of levels allowable from C3-T1 to C2-T1. Previously the device was cleared only for use with autogenous bone graft. This furthers Xtant Medical’s goal of being a comprehensive supplier of products to spine surgeons.

Xtant Medical’s 3Demin and patented OsteoSponge technology are excellent allografts to use with Irix-C due to their ability to compress, fill and expand in the device’s graft chamber, allowing for ideal bone contact and fusion. OsteoVive, a cellular allograft, can also be used in conjunction with Irix-C. This new clearance is indicative of common surgical practices of using allografts in cervical cages to promote fusion.

Dr. Gregory Juda, Chief Scientific Officer of Xtant Medical states, “This new FDA clearance allows Xtant Medical to leverage the clinical effectiveness of our established allograft product offerings for use with our stand-alone interbody devices in cervical discectomy and fusion procedures. We expect that the use of these products as a combined spinal fusion solution will result in positive patient outcomes.”

The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients for treatment of degenerative disc disease.

Xtant Medical estimates the worldwide market for cervical fusion devices at $1.3B and growing. The worldwide market for Demineralized Bone Matrix (DBM) is estimated at $485M. Irix-C, 3Demin, OsteoSponge, and OsteoVive are currently widely available.

About Xtant Medical Holdings

Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical 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 Medical 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: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our 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.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. 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. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
xtant@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

SeaSpine to Present at the Piper Jaffray Healthcare Conference

Posted On November 16, 2016 By OrthoSpineNews In Spine /

CARLSBAD, Calif., Nov. 15, 2016 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today the Company plans to participate in the 28^th Annual Piper Jaffray Healthcare Conference in New York, NY.

SeaSpine’s management is scheduled to present on Tuesday, November 29, 2016 at 3:00 p.m. ET. Interested parties can access the live audio webcast at http://www.seaspine.com.

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.

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

VEXIM again awarded « Fastest growing listed company » in the 2016 Technology Fast 50 for Southwestern France by Deloitte In Extenso

Posted On November 16, 2016 By OrthoSpineNews In Spine /

Toulouse, November 16^th 2016 – VEXIM (FR0011072602 – ALVXM / PEA-PME eligible), a medical device company specializing in the minimally invasive treatment of vertebral fractures, announces that the company has again received the Award of the fastest growing listed company in the 2016 Technology Fast 50 for Southwestern France by Deloitte In Extenso.

Created by Deloitte France in 2001, the Technology Fast 50 extends to all regions in France and showcases the contributions of high-tech companies in boosting economic growth.

VEXIM again stood out for its excellent performance, with an increase in revenue of 404% from 2012 to 2015, representing a growth of +11 132K€ over the period.

As of September, 30^th 2016, VEXIM achieved a cumulated revenue (9 months) of €13 265K, a significant increase of +37% compared with the same period in 2015 reflecting VEXIM’s strong performance on all its European and international markets. VEXIM has now become a key player on the spine trauma market: as of September, 30^th 2016, the total number of implants sold since the launch of the SpineJack® in 2011 came over 38,150 units, representing approximately 18,175 patients treated.

“For the second consecutive time, Deloitte In Extenso Technology Fast 50 rewards VEXIM’s strong performance and dynamism. This is the result of our team’s efforts and I would like to thank all our employees for their dedicated work, as well as our partners and investors who actively support VEXIM’s development and are all part of this success”, commented Vincent Gardès, VEXIM’s CEO.

“The Technology Fast 50 showcases companies shaping the tremendous drive for innovation and value creation of French entrepreneurs, just like VEXIM. The Technology Fast 50 is already over its 16^th edition and has become a standard for French and international investors. We are proud to have VEXIM among our 2016 recipients”, declared Laurent Halfon, Deloitte Partner National Head of the Technology Fast 50 Ranking.

Financial reporting schedule:

2016 sales results: January 17^th, 2017^[1]

About the Technology Fast 50

The Technology Fast 50 was created in 1995 in San Jose (California), in the heart of the Silicon Valley, and was then extended to all the United-States and to the United-Kingdom, Canada, Netherlands, Israel and France. It has now expanded to more than 40 countries and regions in the world and showcases the contributions of high-tech companies in boosting economic growth.

Deloitte has also developed 3 continental rankings:

Europe, Middle-East and Africa: Fast 500 EMEA

North America: Fast 500 North America

Asia Pacific: Fast 500 Asia Pacific

For further information: http://www.fast50france.com/

About VEXIM, the innovative back microsurgery specialist

Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital^[2] and from BPI public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the Masterflow^TM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 64 employees, including its own sales teams in Europe and a network of international distributors.

VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com

SpineJack® ^[3], a revolutionary implant for treating Vertebral Fractures

The revolutionary aspect of the SpineJack® lies in its ability to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.

Masterflow^TM ², a high-performance orthopedic cement delivery system

The Masterflow^TM is an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure for treating vertebral compression fractures. The device provides a better control of the injection of biomaterials into the spine. A complement of the SpineJack®, the Masterflow^TM stands out for being both easy to use and precise, particularly in its ability to stop the cement delivery instantly without inertia. The Masterflow^TM contributes to reducing pain in patients. Its first sales were recorded in the U.S. in February 2015, and the system has also received the CE marking in February 2015, a mandatory conformity mark for products marketed in Europe.

CONTACTS
VEXIM Vincent Gardès, CEO José Da Gloria, Chief Financial Officer investisseur@vexim.com Tél. : +33 5 61 48 48 38		PRESS ALIZE RP Caroline Carmagnol / Wendy Rigal vexim@alizerp.com Tél. : +33 1 44 54 36 66 Tél. : +33 6 48 82 18 94
	Name : VEXIM ISIN code : FR0011072602 Ticker : ALVXM

^[1] Indicative date, subject to changes.

^[2] Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.

^[3] This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Smithsonian Collects Groundbreaking Surgical Device

Posted On November 15, 2016 By OrthoSpineNews In Robotics /

IBM’s Thomas J. Watson Research Center and researchers at the University of California, Davis began the collaborative development of an innovative system for total hip arthroplasty in 1986 to create a more precise device for joint-replacement procedures. ROBODOC became the first surgical robot to perform procedures in the United States in 1992. Performing total hip arthroplasty by hand is not always precise, and there is a possibility that the bone may splinter. The ROBODOC helps prevent these complications through its 3-D image-directed preoperative planning, allowing the computer-guided robot to accurately execute the surgeon’s plan.

The prototype will become part of the museum’s permanent Science and Medicine collections. There are currently no plans for a display.

“We are grateful to be able to include ROBODOC and related materials to the museum’s permanent collections,” said John Gray, the museum’s director. “This donation supports our curators’ goal to explore innovative medical robotics in the advancing field of precision technology and engineering and to document the early history of medial robotics.”

The U.S. Food and Drug Administration approved the ROBODOC in 1998. Since then, it has been used in more than 28,000 procedures worldwide.

Through incomparable collections, rigorous research and dynamic public outreach, the National Museum of American History explores the infinite richness and complexity of American history. It helps people understand the past in order to make sense of the present and shape a more humane future. The museum is continuing to renovate its west exhibition wing, developing galleries on democracy and culture. The museum is located at 14th Street and Constitution Avenue N.W., and is open daily from 10 a.m. to 5:30 p.m. (closed Dec. 25). Admission is free. For more information, visit http://americanhistory.si.edu. For Smithsonian information, the public may call (202) 633-1000.

SOURCE Smithsonian’s National Museum of American History

Why is that salesman in the operating room for your knee replacement?

Posted On November 15, 2016 By OrthoSpineNews In Financial /

By Sandra G. Boodman, November 14, 2016

They are a little-known presence in many operating rooms, offering technical expertise to surgeons installing new knees, implanting cardiac defibrillators or performing delicate spine surgery.

Often called device reps — or by the more cumbersome and less transparent moniker “health-care industry representatives” — these salespeople are employed by the companies that make medical devices: Stryker, Johnson & Johnson and Medtronic, to name a few. Their presence in the OR, particularly common in orthopedics and neurosurgery, is part of the equipment packages that hospitals typically buy.

Many “people who don’t work in health care don’t realize that industry reps are sometimes in the OR,” said Josephine Wergin, a risk management analyst for the ECRI Institute, a Pennsylvania nonprofit that conducts research on medical subjects for the health-care industry. “A lot of times they are the real experts on their products.”

Unlike rotating teams of nurses and surgical techs, reps are a consistent presence, experts say, often functioning as uber-assistants to surgeons with whom they cultivate close relationships and upon whom their six-figure salaries depend.

Although they don’t scrub in, reps are expected to be intimately familiar with the equipment they sell, making sure it is at the ready for the surgeon and poised to answer technical questions.

Who’s the expert?

But how much influence do reps wield, how necessary and costly are their services and does their presence in the OR, which may not be disclosed to patients, raise ethical questions about informed consent? A string of court cases has raised questions about their involvement in surgeries that went awry, dating back to the late 1970s when a New York sales manager who had not graduated from high school tried for three hours to fix a prosthetic hip while one of the surgeons is said to have left the OR.

Despite their role, device reps have received little scrutiny, in sharp contrast to drug salespeople, whose role has been the subject of considerable research.

“There’s so little public awareness of this,” said Adriane Fugh-Berman, an associate professor of pharmacology at the Georgetown University School of Medicine and director of PharmedOut, a project that focuses on prescribing and drug-marketing practices. Fugh-Berman is the co-author of a recent study that raises questions about whether surgeons rely too heavily on reps for technical expertise and assistance, to the potential detriment of patients.

But the cost of medical devices, an industry with about $150 billion in annual U.S. sales, combined with concerns about conflicts of interest by doctors who must report industry payments as part of the Affordable Care Act, has resulted in increased scrutiny, as hospitals from Savannah to Stanford seek to standardize and circumscribe the activities of device salespeople.

READ THE REST HERE

Two-year Scoli-Risk-1 data offer revealing adult spinal deformity results

Posted On November 15, 2016 By OrthoSpineNews In Spine /

11th November 2016

A number of studies presented at the Scoliosis Research Society Annual Meeting (SRS; 21–24 September, Prague, Czech Republic) and at Eurospine (5–7 October, Berlin, Germany) have used two-year follow-up data from the Scoli-Risk-1 study to reveal a multitude of results regarding the impact of surgically treating adult spinal deformity patients across postoperative motor function, complication, revision surgery, depression and proximal junctional kyphosis.

The Scoli-Risk-1 database is a prospective, international, observational, multicentre study, run by the AO Clinical Investigation and Documentation group on behalf of AOSpine and the Scoliosis Research Society. It includes data about 272 patients undergoing surgical correction of high-risk complex adult spinal deformity (eg. Cobb angle >80 degrees). Patients in the database typically went through procedures as complex as three-column osteotomies.

Presentations on the Scoli-Risk-1 study have won a number of awards in recent years, including a 2015 IMAST Whitecloud Award for Best Clinical Paper, the Best Paper Award at the 2015 Global Spine Congress, and the Russell A Hibbs Award for the Best Clinical Research Presentation at the SRS Annual Meeting in 2013.

At SRS, five different presentations covered the Scoli-Risk-1 study. In one presentation, researchers evaluated the data to discover the rate of neurological complication in adult spinal deformity patients at six weeks, six months, and two years (n=196). The research team hypothesised that the postoperative neurological complication rate would be higher than previously reported, due to “the strict postoperative grading of the Lower Extremity Motor Score (LEMS)”, with a “gradual improvement over time.” These expectations were borne out in results, with 23% of patients experiencing such decreased motor function at hospital discharge, 17% at six weeks and ~10% at both six months and two-year follow-up. This data was also presented at Eurospine.

Subgroups of the database were used by different researchers to analyse the association of adult spinal deformity with incidence of depression (see here for a detailed report), and the link between revision surgery and complication rates. The latter presentation, hypothesising that there would be significantly fewer postoperative complications in primary (n=103) than in revision cases (n=160), in fact found no significantly higher rate of postoperative complication. Not only this, but the revision patients actually experienced similar or higher improvements than the primary patients in most self-reported outcomes.

Another SRS study used the database to test the use of a new frailty index (adult spinal deformity frailty index, ASD-FI) in a complex group of patients (see here for a detailed report).

Scoli-Risk-1 data was also used to find the rate of unplanned return to operating room for complex adult spinal deformity patients. As expected by authors, a high rate of unplanned return was found among this population, with 86 unplanned surgeries performed on 60 patients (22%) over the two-year period. The researchers noted the greatest proportion of unplanned return procedures occurred after 30 days (75), with 46% of these caused by implant failure. Wound infection was both the most common cause of return before 30 days (6/11) and the second highest cause post-30 days (22%). Authors speculated that the determination of these risk factors “may be useful for preoperative counselling of patients”, as well as “clinical decision-making.”

The Scoli-Risk-1 study was featured prominently at Eurospine, with two further presentations exploring the incidence of proximal junctional kyphosis in patients with adult spinal deformity involving pelvic fusion, and the rate of major complications in a subgroup of older (≥60) patients.

The former presentation aimed to “investigate the incidence of proximal junctional kyphosis in adult spinal deformity patients fused to the pelvis, and to compare proximal junctional kyphosis rates in patients with long…versus short fusion constructs.” The study found that the incidence in patients with fusion to the pelvis was 23.7 with 9.6% undergoing revision. No significant increase was found between the “long” and “short” fusion groups.

The final Scoli-Risk-1 presentation found that patients aged 60 or above did not experience significantly more postoperative complications (neurological or other major event) in comparison with younger patients. The older group reported similar Oswestry Disability Index and SRS-22r scores, in spite of experiencing more debility.

Life Spine® is Named Winner in RYORTHO 2016 Spine Tech Awards with LONGBOW® Expandable Lateral Spacer System

Posted On November 15, 2016 By OrthoSpineNews In Spine /

November 15, 2016

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it was named a winner in the Eighth Annual Spine Technology Awards, which highlight engineering excellence, innovation and advancement of spinal care, for its LONGBOW Expandable Lateral Spacer System.

“We are honored to be recognized by Robin Young and Orthopedics This Week,” said Michael S. Butler, President and CEO at Life Spine. “The award is a key milestone for this first in class microinvasive expandable lateral product.”

Dr. John Czerwein, Jr. of the Center for Orthopedics, Inc. in Johnston, Rhode Island added, “It is no surprise to me that LONGBOW was chosen for this impressive award. LONGBOW can substantially reduce muscle and tissue retraction and can be back-filled in-situ with about three times as much graft material as a traditional static lateral interbody. These benefits are recognized by myself and my patients as they can reduce operating time, diminish post-surgical pain and speed up recovery time.”

For a list of the ten best new spine technologies for 2016, visit https://ryortho.com/2016/11/the-ten-best-new-spine-technologies-for-2016/

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.

Contacts

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

The Center for Musculoskeletal Disorders (CMD) in Englewood, NJ Performs the First In-office Kyphoplasty in the U.S. with Mazor Robotics Technology

Posted On November 15, 2016 By OrthoSpineNews In Spine /

ORLANDO, FL–(Marketwired – November 15, 2016) – Earlier this month, Dr. Vagmin Vora, assisted by Drs. Lewin, Grossman and PA Issac Abramchayev, performed the first office-based kyphoplasty with Mazor Robotics technology in the U.S. at The Center for Musculoskeletal Disorders. The procedure did not require the patient to be intubated and she was able to go home within three hours. CMD, located in Englewood, NJ, is a joint private practice including The Center for Spinal Disorders, The Center for Hand Disorders and The Center for Pain Management.

“Mazor Robotics technology has opened up a new vista by enabling spine surgery to be performed with exceptional accuracy and precision in an ambulatory surgery setting,” said Dr. Vora.

Kyphoplasty is generally performed to treat a spinal fracture through stabilization of the bone. In this case, the precise guidance of the Mazor Robotics Renaissance® system was used to create a micro incision in the patient’s back. A narrow tube was inserted to create a path to the fractured area and a balloon-type device was inflated through the tube to restore the height of the vertebrae, followed by the insertion of the cement.

Anesthesiologist Dr. Leon Shapiro provided sedation to the patient and commented, “We were able to maintain a motionless patient throughout the entire procedure without administering any narcotic medication.”

About The Center for Musculoskeletal Disorders (CMD)

The Center for Musculoskeletal Disorders (CMD) is a formalized joint practice including The Center for Spinal Disorders, The Center for Hand Disorders and The Center for Pain Management. Since the three centers have long worked together to provide cohesive care to the community, our newly integrated practice will continue our steadfast servitude to our patients. Our specialty-trained physicians and staff share the common philosophy of highly personalized care. We stress non-surgical solutions whenever possible and use cutting-edge medical and surgical techniques to customize advanced treatments for our patients’ needs.

About Mazor

Mazor Robotics (TASE: MZOR) (NASDAQ: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in a precise manner. For more information, please visit http://www.MazorRobotics.com.

Month: November 2016

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