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Orthopedic and Dental Industry News

August 2011

Dental News Roundup August 2011 BY LAUREN UZDIENSKI, AUGUST 31, 2011

Nobel, Straumann announce earnings . . . Dentsply closes Astra Tech acquisition . . . Keystone Dental initiates post-market study of Genesis Biomimetic Implant System more

Global Obesity Rates Doubled Since 1980, Will Continue to Rise BY LAUREN UZDIENSKI, AUGUST 30, 2011

On Friday the Lancet published a four-part series on obesity that illustrated the climbing rates of obesity around the world. Obesity, and the associated strain on the musculoskeletal system, has long been considered a driver of growth in the orthopedic space. more

HHS Introduces Bundled Payments Pilot for Inpatient Surgical Procedures BY LAUREN UZDIENSKI, AUGUST 29, 2011

The U.S. Department of Health and Human Services introduced a new pilot program that will bundle payments for inpatient services delivered across an episode of care, such as hip replacement, rather than paying for services separately. more

Musculoskeletal News Roundup 25-Aug-11 BY LAUREN UZDIENSKI, AUGUST 25, 2011

Corin, Medtronic announce earnings . . . FDA clears DePuy's TRUMATCH Solutions . . . Ellipse Technologies receives 510(k) clearance . . . FDA expands Zyga's indications for the SImmetry Sacroiliac Joint Fusion System . . . Mesoblast announces first phase II procedure evaluating MPCs for the treatment of low back pain . . . VG Innovations launches modified VerteLoc system . . . Sanuwave and Spinal Restoration receive U.S. patents . . . Zyga Technologies enrolls first EU patients in GLYDER study more

Omar Ishrak Striving to Restore Growth at Medtronic BY LAUREN UZDIENSKI, AUGUST 24, 2011

On Medtronic's Tuesday earnings call, new CEO Omar Ishrak announced that his top priority was restoring growth to the company, which he said was achievable by improving execution, optimizing innovation and accelerating globalization. more

Metal-on-Metal Hip Complaints Surging: NYT Analysis BY SANDER DUNCAN, AUGUST 23, 2011

The FDA received more complaints about metal-on-metal hip implants this year to date than in the preceding four years combined, according to a New York Times analysis of FDA data. more

Baxter Buys Ceremed's Ostene BY LAUREN UZDIENSKI, AUGUST 23, 2011

Ceremed announced today that their Ostene hemostat, including all branding and manufacturing rights, has been sold to Baxter for an undisclosed amount. Ceremed says the divestiture will "free up assets needed to focus on bringing new products to market." more

Musculoskeletal News Roundup 18-Aug-11 BY LAUREN UZDIENSKI, AUGUST 18, 2011

KH, DJO and KNSY announce earnings . . . FDA clears ARTC's SpeedLock Knotless Fixation Device . . . NovaBone launches MacroPor-Si+ . . . Pioneer Surgical announces first U.K. case for the nanOss cervical cage . . . Captiva Spine and Crosstrees Medical receive new U.S. patents . . . Misonix announces new distribution agreement for Australia and New Zealand more

Facebook Opens Comments on Device, Drug Manufacturers' Pages BY LAUREN UZDIENSKI, AUGUST 17, 2011

Facebook reversed a policy this week that exempted device and drug manufacturers from opening their walls, or comment pages, on the site. Manufacturers are generally opposed to open comment pages for compliance reasons - posters can discuss adverse events or off-label uses, both of which can raise red flags for the FDA - and have spoken out against the new rule. Further, many companies are shutting down their Facebook pages. more

FDA Releases Draft Guidance on the PMA BY LAUREN UZDIENSKI, AUGUST 16, 2011

Furthering its efforts at transparency in its regulatory processes, the FDA released new guidance on Monday regarding clinical study expectations for medical devices. Among the topics addressed in the document are selecting patients, sites and objectives, appropriate controls and sustaining a level of evidence. more

Joseph DeVivo Lands at AngioDynamics BY LAUREN UZDIENSKI, AUGUST 16, 2011

Effective September 7, Smith & Nephew's former President of Orthopedics, Joseph M. DeVivo, will assume the role of President and Chief Executive Officer at AngioDynamics. more

Medtronic to Double Chinese Workforce BY SANDER DUNCAN, AUGUST 11, 2011

Medtronic sees a bright future in China, seeking to double its workforce there by 2016. Meanwhile, it's new Asia-Pacific headquarters recently opened in Shanghai along with a globally-focused R&D center. more

Musculoskeletal News Roundup 11-Aug-11 BY SANDER DUNCAN, AUGUST 11, 2011

ETR:AAQ, MAKO, VTX:SYST, TRNX, TSON announce earnings . . . Symmetry to acquire Olsen Medical . . . Integra introducing cervical implant . . . Relievant Medsystems and SI-BONE each pursuing IDE studies . . . Corin extends relationship with LARS more

Gov. Rick Perry Brings Attention to Stem Cells BY LAUREN UZDIENSKI, AUGUST 10, 2011

Texas governor Rick Perry may be known for his economic conservatism and criticism of President Obama's healthcare overhaul, but lately he's been in the media for a different reason: his support of the use of autologous stem cells in the U.S. Gov. Perry recently underwent a spinal fusion to treat a "recurring back injury", during which he received a dose of his own cultured stem cells. Perry and his surgeon have become public champions for the procedure. more

Cornell Researchers' Engineered Spinal Discs Show Promise BY LAUREN UZDIENSKI, AUGUST 9, 2011

A study published in the Proceedings of the National Academy of Sciences demonstrated how Cornell researchers managed to engineer an artificial disc made from a collagen scaffold, a synthetic gel nucleus and living sheep cells. The discs were evaluated in a small animal model. more

Chicago Surgeons Give Back BY LAUREN UZDIENSKI, AUGUST 8, 2011

Founded in 1995, Operation Walk is a not-for-profit organization founded in 1995 with the aim of bringing needed large joint surgeries to patients throughout the globe, primarily in the third world. Volunteer surgical teams have participated in trips to Cuba, China, Nepal, Philippines, Nicaragua, Peru, Guatemala, El Salvador, Panama and Ecuador. Now the Chicago Tribune is praising two surgeons striving to help Chicago-area patients lacking insurance or access to hip or knee replacements. more

Medtronic Funds Yale Reviews of Infuse BY SANDER DUNCAN, AUGUST 5, 2011

Following significant media and academic backlash against Infuse, Medtronic is taking several novel steps toward developing data transparency and defending the science behind its product. more

Musculoskeletal News Roundup 4-Aug-11 BY LAUREN UZDIENSKI, AUGUST 4, 2011

ATEC, ANIK, ARTC, BMTI, EXAC, SNN, SMA announce earnings . . . Ellipse Technologies announces series C round . . . CMS announces IPPS final rule . . . KFx Medical sues Arthrex . . . Tornier initiates IDE study more

FDA Lowers User Fees in FY2012 BY LAUREN UZDIENSKI, AUGUST 2, 2011

The FDA will offset excessive user fee payments with a small reduction in fees for devicemakers in FY2012, according to documents released on Monday. Over the past few fiscal years, the agency has collected $9.5 million beyond what was appropriated, and this will be returned to industry in the form of a 7% reduction in registration fees as well as lower application submission fees. more

FDA and Industry React to the IOM's 510(k) Report BY LAUREN UZDIENSKI, AUGUST 1, 2011

The IOM's surprising recommendation that the 510(k) process should be scrapped was met with objections on Friday. Among the opposition to the proposal was the FDA, who requested this study back in 2009. more

Alphatec Holdings, Inc. Names Leslie H. Cross Chairman of the Board of Directors BY EDITOR, AUGUST 1, 2011

Alphatec Holdings, Inc. today announced that its Board of Directors elected Leslie H. Cross the non-executive Chairman of the Board of Directors. more


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