Study points a way to better implantable medical devices

Posted On March 22, 2017 By OrthoSpineNews In Biologics /

Science Daily, Source: Massachusetts Institute of Technology – March 20, 2017

Medical devices implanted in the body for drug delivery, sensing, or tissue regeneration usually come under fire from the host’s immune system. Defense cells work to isolate material they consider foreign to the body, building up a wall of dense scar tissue around the devices, which eventually become unable to perform their functions.

Researchers at MIT and Boston Children’s Hospital have identified a signaling molecule that is key to this process of “fibrosis,” and they have shown that blocking the molecule prevents the scar tissue from forming. The findings, reported in the March 20 issue of Nature Materials, could help scientists extend the lifespan of many types of implantable medical devices.

“This gives us a better understanding of the biology behind fibrosis and potentially a way to modulate that response to prevent the formation of scar tissue around implants,” says Daniel Anderson, an associate professor in MIT’s Department of Chemical Engineering, a member of MIT’s Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science (IMES), an affiliate at Boston Children’s Hospital, and the senior author of the study.

The paper’s lead author is Koch Institute and JDRF postdoc Joshua Doloff.

Preventing fibrosis

Anderson’s lab has been working for several years on an implantable device that could mimic the function of the pancreas, potentially offering a long-term treatment for diabetes patients. The device encapsulates insulin-producing islet cells within a material called alginate, a polysaccharide naturally found in algae. Alginate provokes a lesser immune response than human-made materials such as metal, but it still induces fibrosis.

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The robotic have-not: How J&J plans to woo hospitals, knee surgeons

Posted On March 22, 2017 By OrthoSpineNews In Recon, Robotics /

By ARUNDHATI PARMAR – MedCity News, March 17, 2017

Johnson & Johnson and Verily Life Sciences (formerly Google Life Sciences) have a joint venture to create the next generation of robotic surgery souped up with digital technologies in the future. (Watch out Intuitive Surgical.)

But when it comes to hip and knee replacement today, J&J Depuy Synthes is a robotic have-not.

Competitors have robots or are close to having something robotic in joint replacement.

On Tuesday, Stryker launched its total knee application on the expensive Mako robotduring the annual meeting of the American Academy of Orthopaedic Surgeons in San Diego. That same day at AAOS, Smith & Nephew previewed its hand-held robot-assisted device for total knee replacements in advance of a market release in the second quarter. And Zimmer-Biomet was also proudly displaying its robot on the exhibit floor — the Rosa robot acquired with the purchase of French firm Medtech SA – although the robot won’t be doing total knee replacements until 2018.

There is a general notion that robotics will gain ground in orthopedic surgery though the predictions around adoption pace vary greatly.

One analyst — Brandon Henry from RBC Capital Markets — believes Stryker will be the clear winner with the launch of its total knee on its Mako robotic system and will take market share away from Johnson & Johnson DePuy Synthes and Zimmer-Biomet in the next few years. Another — Richard Newitter from Leerink Partners — believes robotics adoption will be much more gradual and only in complex cases but still having one in the short term is better than not having one.

So in the meantime without a robot, how can J&J DePuy Synthes woo hospitals and knee surgeons, some of whom are part of Medicare’s mandatory 90-day bundled payment program called the Comprehensive Care for Joint Replacement.

Company executives are relying on the wide breadth of J&J’s knee offerings, its services chops and a new company-sponsored whitepaper that touts the economic value of its Attune Knee.

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Spineway : First Mont-Blanc MIS implant in the USA

Posted On March 21, 2017 By OrthoSpineNews In Spine /

Ecully, 21 March 2017

Spineway, French specialist in surgical implants and instruments for treating disorders of the spinal column (spine), announces the completion of the first minimally invasive surgery using its Mont-Blanc MIS product line in the United States. The operation was performed by Dr. Ludwig Orozco, neurosurgeon in Dallas (Texas). It is a perfectly demonstrative achievement, given the patient condition was more complex than a typical lumbar osteoarthritis. A recent distribution agreement signed with SLR Medical Consulting was a driving force in this realization.

This first implantation of the Mont-Blanc MIS was performed on a patient presenting with degeneration on several vertebral levels. Its surgical treatment required the use of 8 pedicle screws and 2 titanium-alloy rods from Spineway’s innovative Mont Blanc MIS line. These instruments are perfectly adapted to meet practitioners’ growing needs for increasingly technological tools, like constructs involving over 3 vertebral levels, as in the present case. This line provides surgeons with highly technical instruments, all based on Spineway’s expertise in correcting spinal curvatures. The new Mont Blanc MIS instruments already allow for the treatment of several types of lumbar-spine disorders.

Minimally invasive surgery is currently the most dynamic segment of the worldwide market for spinal implants. Less traumatic for the patient, this type of surgery is less painful, and allows for a faster recovery and shorter hospital stays. This operating technique should, in the medium-term, become the standard technique for most surgeries.

This first successful operation allows Spineway to position itself in the US market on a high-growth segment with an innovative line offering surgeons a multitude of possibilities. Based on the success of its international launch, Spineway is continuing the commercial marketing and deployment of its already highly-technical products and plans to accelerate its R&D in order to widen the scope of application of its technologies, to cover a larger range of disorders.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLAN FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication:
2016 Annual Results – 25 April 2017, after market closes

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015).
ISIN code: FR0011398874 – ALSPW

Contacts:


*Investor Relations* David Siegrist – Finance Director Tel: +33 (0)4 72 77 01 52 finance.dsg@spineway.com		*Financial Communication* Jérôme Gacoin / Solène Kennis Tel: +33 (0)1 75 77 54 68 skennis@aelium.fr

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/5e2e8d19-9523-4a51-896e-71446127fe6b

Obamacare Replacement Will Permanently Remove Medical Device Tax

Posted On March 21, 2017 By OrthoSpineNews In Regulatory /

By Jof Enriquez – March 9, 2017

Republican leaders in the U.S. House of Representatives have unveiled proposed legislation to repeal and replace the Affordable Care Act, which, among several tax cuts, will eliminate permanently the 2.3 percent excise tax on medical devices and products.

The device tax has been suspended since December 2015, but GOP lawmakers and industry lobbyists have been pushing for a permanent repeal of a tax that they claim is detrimental to U.S. medtech innovation, as well as a jobs killer. A House of Representatives bill seeking to fully repeal the tax was filed in January.

Unveiled this week, the replacement of Obamacare known as the American Health Care Act (AHCA), will likely achieve the full repeal, beginning Jan. 1, 2018, according to RAPS.

The bill would repeal nearly all Obamacare taxes that would have cost health insurance firms, medical device makers, and other healthcare companies tens of billions of dollars over the next decade, reports The Washington Post.

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UnitedHealth Group Announces Extension of Exchange Offer to Acquire Surgical Care Affiliates, Inc.

Posted On March 20, 2017 By OrthoSpineNews In Financial /

March 17, 2017

MINNETONKA, Minn.–(BUSINESS WIRE)–UnitedHealth Group Incorporated (NYSE: UNH) today announced that it has extended the expiration of its previously announced exchange offer for all of the outstanding shares of Surgical Care Affiliates, Inc. (NASDAQ: SCAI) (“SCA”), a leading ambulatory surgery center and surgical hospital provider. The exchange offer, which was previously scheduled to expire at 12:01 a.m., New York City time, on Tuesday, March 21, 2017, has been extended until 12:01 a.m., New York City time, on Friday, March 24, 2017, unless further extended. All other terms and conditions of the exchange offer remain unchanged.

Wells Fargo Bank, N.A., the depositary for the exchange offer, has advised UnitedHealth Group that, as of 5:00 p.m., New York City time, on March 16, 2017, 13,211,520 shares of SCA common stock were tendered pursuant to the exchange offer, which represented approximately 32.5% of the outstanding shares of common stock of SCA. Stockholders who have already tendered their shares of SCA common stock do not have to re-tender their shares or take any other action as a result of the extension of the expiration date of the exchange offer.

The combination of SCA with OptumCare, the primary and urgent care delivery services business part of Optum (UnitedHealth Group’s services business), which works with more than 80 health plans, will position the combined organization as a comprehensive provider of ambulatory care services, while continuing expansion of SCA’s network of ASCs and surgical hospitals in partnership with leading health systems, medical groups and health payers. The combination builds upon the two companies’ successful ambulatory surgery center collaborations and expands OptumCare’s capabilities in outpatient surgical procedures.

In connection with the exchange offer, UnitedHealth Group has filed a registration statement on Form S-4, which includes a prospectus/offer to exchange and certain ancillary documentation, which have been be mailed to SCA stockholders, and a tender offer statement on Schedule TO and amendments thereto with the SEC. SCA has filed a solicitation/recommendation statement on Schedule 14D-9 that has also been mailed to SCA stockholders. These documents contain important information about the exchange offer that should be read carefully before any decision is made with respect to the exchange offer.

Requests for copies of the prospectus/offer to exchange, the accompanying letter of transmittal and other exchange offer materials may be directed to D.F. King & Co., Inc., the information agent for the exchange offer, by phone toll-free at (800) 431-9645 or by email at UNH@dfking.com.

About UnitedHealth Group

UnitedHealth Group (NYSE: UNH) is a diversified health and well-being company dedicated to helping people live healthier lives and making the health system work better for everyone. UnitedHealth Group offers a broad spectrum of products and services through two distinct platforms: UnitedHealthcare, which provides health care coverage and benefits services; and Optum, which provides information and technology-enabled health services. For more information, visit UnitedHealth Group at www.unitedhealthgroup.com or follow @UnitedHealthGrp on Twitter.

About Optum

Optum is a leading information and technology-enabled health services business dedicated to helping make the health system work better for everyone. With more than 100,000 people worldwide, Optum delivers intelligent, integrated solutions that help to modernize the health system and improve overall population health. Optum is part of UnitedHealth Group (NYSE:UNH).

About SCA

SCA (NASDAQ: SCAI), a leader in the outpatient surgery industry, strategically partners with health plans, medical groups and health systems across the country to develop and optimize surgical facilities. SCA operates 205 surgical facilities, including ambulatory surgery centers and surgical hospitals, in partnership with approximately 3,000 physicians. For more information on SCA, visit www.scasurgery.com.

Cautionary Note Concerning Forward-Looking Statements

This communication may contain statements that constitute “forward-looking statements,” including, for example, information related to UnitedHealth Group, SCA and the proposed acquisition of SCA by UnitedHealth Group. Generally the words “believe,” “expect,” “intend,” “estimate,” “anticipate,” “plan,” “project,” “should” and similar expressions identify forward-looking statements, which generally are not historical in nature. Such statements reflect the current analysis of existing information and involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the possibility that various conditions to the consummation of the UnitedHealth Group exchange offer and mergers may not be satisfied or waived, including the receipt of regulatory clearances related to the mergers; uncertainty as to how many shares of SCA common stock will be tendered into the UnitedHealth Group exchange offer; the risk that the UnitedHealth Group exchange offer and mergers will not close within the anticipated time periods, or at all; the failure to complete or receive the anticipated benefits from UnitedHealth Group’s acquisition of SCA; the possibility that the parties may be unable to successfully integrate SCA’s operations into those of UnitedHealth Group; such integration may be more difficult, time-consuming or costly than expected; customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients, suppliers or physicians) may be greater than expected following the transaction; the retention of certain key employees at SCA may not be achieved; the parties may be unable to meet expectations regarding the timing, completion and accounting and tax treatments of the transactions; the effects of local and national economic, credit and capital market conditions; and the other risks and uncertainties relating to UnitedHealth Group and SCA described in their respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2016, and in their subsequent Current Reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission (the “SEC”) and available at www.sec.gov.

UnitedHealth Group and SCA assume no obligation to update the information in this communication, except as otherwise required by law. Readers are cautioned not to place undue reliance on these forward-looking statements or information, which speak only as of the date hereof.

Additional Information and Where to Find It

This communication relates to a pending business combination transaction between UnitedHealth Group and SCA. This communication is for informational purposes only and is neither an offer to sell or exchange, nor a solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

UnitedHealth Group has filed a registration statement on Form S-4 related to the transaction with the SEC and may file amendments thereto. UnitedHealth Group and a wholly-owned subsidiary of UnitedHealth Group have filed a tender offer statement on Schedule TO (including a prospectus/offer to exchange, a related letter of transmittal and other exchange offer documents) related to the transaction with the SEC and have filed amendments thereto and may file further amendments thereto. SCA has filed a solicitation/recommendation statement on Schedule 14D-9 with the SEC and has filed amendments thereto and may file further amendments thereto. SCA and UnitedHealth Group may also file other documents with the SEC regarding the transaction. This communication is not a substitute for any registration statement, Schedule TO, Schedule 14D-9 or any other document which SCA or UnitedHealth Group has filed or may file with the SEC in connection with the transaction. Investors and security holders are urged to read the registration statement, the Schedule TO (including the prospectus/offer to exchange, related letter of transmittal and other exchange offer documents), the solicitation/recommendation statement on Schedule 14D-9 and the other relevant materials with respect to the transaction carefully and in their entirety before making any decision regarding exchanging their shares, because they contain important information about the transaction. The prospectus/offer to exchange, the related letter of transmittal and certain other exchange offer documents, as well as the solicitation/recommendation statement, will be made available to all holders of SCA’s stock at no expense to them. The exchange offer materials and the solicitation/recommendation statement are available for free at the SEC’s website at www.sec.gov. Additional copies of the exchange offer materials and the solicitation/recommendation statement may be obtained for free by contacting UnitedHealth Group’s Investor Relations department at (800) 328-5979. Additional copies of the solicitation/recommendation statement may be obtained for free by contacting SCA’s Investor Relations department at (800) 768-0094.

In addition to the SEC filings made in connection with the transaction, each of UnitedHealth Group and SCA files annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other such filed information at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. UnitedHealth Group’s and SCA’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.

Click here to subscribe to Mobile Alerts for UnitedHealth Group.

Contacts

UnitedHealth Group
Investors:
John Penshorn, 952-936-7214
Senior Vice President
or
Brett Manderfeld, 952-936-7216
Vice President
or
Media:
Tyler Mason, 424-333-6122
Vice President
Tyler.Mason@uhg.com

Spinal Elements® Announces Initial Procedures with Lucent® XP Expandable Interbody Implant

Posted On March 20, 2017 By OrthoSpineNews In Spine, Top Stories /

March 20, 2017

CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, announced that the first procedures with its Lucent XP expandable interbody implant have been successfully completed.

The Lucent XP System is an interbody device that can expand in height and increase in lordotic angle after it has been surgically implanted. The height expansion helps restore the height of the spinal disc space and the lordotic angling helps correct the curvature of the spine. With the Lucent XP device, surgeons can achieve up to 15 degrees of lordotic angle, helping restore sagittal balance for the patient.

The Lucent XP system is made primary of polyetheretherketone (PEEK), a radiolucent material with a lower modulus of elasticity than titanium, the primary material of many competitive systems. The PEEK mechanical properties along with the design of the device allow for a more load-sharing construct. The radiolucency allows for post-operative evaluation of the fusion progression. Additionally, the device is coated with Spinal Elements’ Ti-Bond® porous titanium coating. Ti-Bond is a hydrophilic coating applied at the bone-contacting endplates of the implant.

Hyun Bae, MD, a leading spine surgeon who practices at The Spine Institute in Los Angeles, California, had this to say about his experience with the Lucent XP System: “The ease of use of this system and the ability of the device to expand in height and restore lordotic angle are exactly what I need to address the challenges spinal fusion surgery for my patients.

Paul Kim, MD, of the Spine Institute of San Diego, added, “The clinical importance of height restoration and spinal curvature cannot be understated. Spinal Elements’ system provides these features without making sacrifices relative to construct rigidity or post-operative ability to monitor the progress of a fusion. Furthermore, I was able deploy the system safely and efficiently with a minimally invasive surgical approach.”

Spinal Elements will be more widely launching the Lucent XP expandable interbody device in the summer of 2017. The company has seen over 20% growth of the past year in its core technologies, fueled by demand for its advanced technologies including Ti-Bond coated implants.

About Spinal Elements

Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® porous titanium coated PEEK interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefiting children with life-threatening medical conditions. The company recently launched a warranty program for its Ti-Bond technology based on the success of over 10,000 devices implanted. For more information, please visit www.spinalelements.com.

Contacts

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

NuVasive announces new evidence-based recommendation released from NICE (U.K.) for Lateral Interbody Fusion

Posted On March 20, 2017 By OrthoSpineNews In Spine /

SAN DIEGO, March 20, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced updated guidance from the National Industry for Clinical Excellence (NICE) in the U.K. for lateral interbody fusion in the lumbar spine. NICE stated the evidence on efficacy for lateral interbody fusion is adequate in quality and quantity and the procedure may be used provided that standard arrangements are in place for clinical governance, consent and audit. The majority of the evidence submitted to and reviewed by the panel was peer-reviewed journal articles describing the now 14-year experience with and outcomes following the Company’s eXtreme Lateral Interbody Fusion (XLIF®) procedure, the leading global lateral approach spine surgical technique.

“Our continued investment into clinical research and outcomes data from our XLIF procedure was supportive in NICE releasing updated guidance for this innovative surgical approach,” said Jason Hannon, NuVasive’s president and chief operating officer. “Our team has worked diligently with NICE since 2015 to gather, analyze and review the available evidence. The updated guidance further supports the clinical efficacy of XLIF and will help expand the availability of XLIF to back pain sufferers in the U.K. and around the world.”

With more than 150,000 successful surgeries around the world, XLIF is the leading global lateral approach procedure. First introduced in the U.S. in 2003, XLIF is a minimally invasive surgical procedure performed through the side of the body, utilizing proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies.

Initial NICE guidance for lateral interbody fusion was published in 2009 with additional special measures that impacted adoption of the procedure in the UK. In response to a request for input prior to a planned re-review of NICE guidance, NuVasive submitted a large body of evidence for the XLIF procedure, including data outlining safety profile, rate of fusion, and improvements in pain and disability. The updated guidance was supported by a systematic literature review of more than 200 previously published studies as a high-quality summary of the safety and efficacy of the XLIF procedure¹. For more information on the updated NICE guidance for lateral interbody fusion, visit https://www.nice.org.uk/guidance/ipg574.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $956 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. 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.

¹ Lehmen JA et al. Eur Spine J 2015;24(Suppl 3):S287–S313

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

Mazor Robotics and Medtronic Combine Efforts on the Commercialization of Mazor X™: An Innovative Guidance System for Spine Surgery

Posted On March 20, 2017 By OrthoSpineNews In Robotics, Spine /

ORLANDO, Fla., March 17, 2017 /PRNewswire/ — Mazor Robotics Ltd. is a global leader in the development and distribution of innovative surgical guidance systems for spine and brain surgery. Mazor Robotics Inc., the US subsidiary of Mazor Robotics LTD is recognized as one of largest players in the robotics and simulation industry in the State of Florida, their US headquarters are in downtown Orlando. In nearby Celebration, The Florida Hospital Nicholson Center serves as the national training center for the new Mazor X™, a transformative platform for spine surgeries, having trained over 100 surgeons from all over the United States in 2016.

“As a pioneer and a leader in the field of surgical guidance systems, Mazor Robotics saw two significant milestones in 2016: the launch of our strategic partnership with Medtronic followed by the commercial release of the new Mazor X™. We are very excited to see what 2017 brings for our company,” says: Christopher Prentice, CEO Mazor Robotics, Inc.

Since signing the agreement in May 2016, Mazor and Medtronic have invested in co-marketing, promotion, and training efforts towards commercialization of Mazor X™, a transformative platform for spine procedures that launched in October at the North American Spine Society (NASS) Annual Meeting. Between the two companies, there are now hundreds of highly experienced capital and clinical specialists responsible for raising the awareness of, selling and supporting Mazor X.

Mazor Robotics (TASE: MZOR; NASDAQ-GM: MZOR) believes in healing through innovation by developing and introducing revolutionary technology 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 more accurate and secure manner. For more information, please visit www.MazorRobotics.com.

SOURCE Mazor Robotics Ltd.

Degree of spinal deformity affects hip replacement surgery success

Posted On March 20, 2017 By OrthoSpineNews In Recon, Spine /

PUBLIC RELEASE: 17-MAR-2017 – NYU LANGONE MEDICAL CENTER / NEW YORK UNIVERSITY SCHOOL OF MEDICINE

People with spinal deformity also requiring a total hip replacement are at greater risk for dislocation or follow-up revision surgery, suggesting that these higher-risk patients may benefit from a more personalized approach to their surgeries to reduce the risk of poorer outcomes.

A new study led by orthopaedic surgeons at NYU Langone Medical Center provides a greater understanding of exactly how spinal deformity interacts with the pelvis, potentially increasing risk despite implanting the artificial hip in what is traditionally considered a “safe zone” by surgeons.

“Surgeons should anticipate potential instability after performing a hip replacement in patients who have existing spinal deformity, and they should adjust their surgical plans accordingly,” says lead study author Aaron J. Buckland, MD, assistant professor of Orthopaedic Surgery in the division of Spine Surgery and director of spine research at NYU Langone.

The study was presented March 17, 2017 at the American Academy of Orthopaedic Surgeons (AAOS) 2017 Annual Meeting in San Diego, California. These findings also were published online December 27, 2016 in the Journal of Arthroplasty.

More than 310,000 hip replacements are performed in the U.S. each year, with rates dramatically increasing over the past two decades in younger adults 45 to 64 years of age who are active and living longer than ever before. An estimated 2.5 million Americans are currently living with hip replacements.

In a hip replacement, an artificial joint comprised of a ball and socket is implanted to replace the natural socket in the pelvis, enabling movement that is typical of the hip joint. For the past 40 years, surgeons have placed the socket (known as the acetabular cup) adjacent to the pelvic bone in a so-called “safe zone” — a position that is thought to reduce risk of dislocation. However, the new research suggests that placing the cup in the safe zone may not be enough to prevent dislocation in patients with spinal deformity.

Until now, no studies of the hip-spine relationship have focused on patients with sagittal spinal deformity, says Dr. Buckland. “Our research helps bridge any disconnect between surgeons who regularly treat spinal deformities and those who perform hip joint replacements, fostering more collaboration to improve patient outcomes,” he adds.

READ THE REST HERE

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Leading International Spine Surgeons Praise AxioMed Viscoelastic Disc as “Game Changer” for Spine Surgery

Posted On March 20, 2017 By OrthoSpineNews In Spine /

MALDEN, MA (PRWEB) MARCH 15, 2017

Leading internationally renowned surgeons and their patients have hope that AxioMed’s first-of-its-kind viscoelastic disc replacement – which acts as a cushion between the vertebrae – will give hope to millions who suffer from back and neck pain and who are looking to maintain their normal activities post spine surgery.

Surgeons and patients who have experience with the AxioMed Freedom Disc have reacted overwhelmingly positively. “I have seen some of the postoperative X-rays noting that the AxioMed disc restores height, restores normal motion, and more patients are giving testimonials on getting back their quality of life,” says AxioMed President Jake Lubinski.

Dr. Kenneth Pettine, an experienced total disc replacement spine surgeon and part of the lumbar IDE study, calls it “the best artificial lumbar disc there is.” Dr. Robert Pflugmacher, spinal surgeon from Bonn, Germany, credits ease of use and positive results to AxioMed’s success in spinal disc rankings. The disc “imitates our nature, because our natural disc is viscoelastic,” explains Professor Dr. Burkhard Rischke.

Patient testimonials are life changing. Patient Kristen Lee, personal trainer and yoga instructor, explains, “I find that having undergone the Freedom Total Disc Replacement surgery, I have been given back my life. I was able to walk the next day without pain. I am more active now than I was pre-surgery.” Marathon runner and TDR patient Robert Ramsey credits the AxioMed disc immensely, stating, “The Freedom Disc has given me my life back.” Former American Gladiator winner Robin Coleman is back to her lifestyle and enjoying riding horses again.

Dr. Kingsley R. Chin points out the mechanics of the disc’s success, outlining, “When you look at this disc with its viscoelastic properties you now have a disc that truly mimics the human disc. The bond between the viscoelastic material and the Titanium endplates are very strong and its a single piece device no moving pieces. And so now, you are able to insert this disc easily. It’s going to be reliable for longevity. It’s a one piece device that does not have a keel. So putting this disc anteriorly in the lumbar spine or cervical spine is pretty easy. The ability for us to then put it in laterally in the lumbar spine, I think will be a game changer, and that’s what we’re going to do.”

View full video coverage here.

Month: March 2017

Study points a way to better implantable medical devices

The robotic have-not: How J&J plans to woo hospitals, knee surgeons

Spineway : First Mont-Blanc MIS implant in the USA

Obamacare Replacement Will Permanently Remove Medical Device Tax

UnitedHealth Group Announces Extension of Exchange Offer to Acquire Surgical Care Affiliates, Inc.

Contacts

Spinal Elements® Announces Initial Procedures with Lucent® XP Expandable Interbody Implant

Contacts

NuVasive announces new evidence-based recommendation released from NICE (U.K.) for Lateral Interbody Fusion

Mazor Robotics and Medtronic Combine Efforts on the Commercialization of Mazor X™: An Innovative Guidance System for Spine Surgery

Related Links

Degree of spinal deformity affects hip replacement surgery success

Leading International Spine Surgeons Praise AxioMed Viscoelastic Disc as “Game Changer” for Spine Surgery