DePuy Orthopaedics inched a step closer to Food & Drug Administration approval of its experimental ceramic-on-metal hip replacement implant, after a federal watchdog agency review of the device indicated it’s no better or worse than already-approved implant technologies, according to news reports.
Rapid tests for the Swine Flu, performed in a doctor’s office, fail to detect the H1N1 influenza virus more than half the time according to a small study, the New York Times reported.
And the bone cement commonly used to repair fractured vertebrae is no more effective than a placebo, according to a pair of other small studies reported in the Wall Street Journal (subscription).
Swine Flu tests
Yesterday was a tough one for Johnson & Johnson.
Not only did the New Brunswick, N.J.-based conglomerate post second-quarter sales and earnings declines, but it also revealed that New Jersey Attorney General Anne Milgram subpoenaed its DePuy Orthopaedics subsidiary for documents related to the “financial interests of clinical investigators who performed clinical studies for DePuy Orthopaedics, Inc. and DePuy Spine, Inc.,” according to a federal Securities and Exchange Commission filing.
Trevor Larson, the former salesman, took a job last month with the Stryker Corp. distributor after six years covering Smith & Nephew’s territories in Minnesota and Wisconsin.
The lawsuit accuses Osteologic and Larson of knowingly violating a non-competition clause and seeks damages of at least $6 million.
Orthofix International N.V. won CE Mark approval from the European Union for its Advent cervical disc.
The McKinney, Texas-based company, which has operations in Boston, said it plans to begin marketing the device in Europe during the fourth quarter.
It’s also running a study of the Advent disc, involving 100 patients in 15 medical centers, ahead of seeking similar approval from the U.S. Food & Drug Administration. Orthofix plans to add 10 more study sites in the U.S. this year, taking the total number of enrolled patients to 450.
ConforMIS Inc. raised $50 million from a group of private and government investors.
The Burlington partial knee implant maker, which developed technology to manufacture surgical implants and instrument custom-made to patients’ physiology, said the Series D round came from private equity firms led by prior investor Aeris Capital and the sovereign funds of foreign governments including Singapore and Kuwait.
A few months after settling federal allegations that they ran kickback schemes, five orthopedic device makers say their new procedures ensure that their interactions with surgeons are transparent, above-board and, above all, absolutely necessary to the development of new devices and technologies.
Bone growth biologics were used in about 25 percent of all U.S. spinal fusion surgeries in 2006, caused more frequent complications and cost more, according to a study in the Journal of the American Medical Assn.
That’s bad news for Medtronic and Stryker Biotech, which make the BMPs examined in the study of more than 328,000 patients undergoing spinal fusion procedures from 2002 to 2006.
It showed that BMP usage increased from 0.69 percent of all fusions in 2002 to 24.89 percent in 2006 and cost between 11 percent and 41 percent more than spinal fusions performed without it.
Aquamer Medical Corp. is sinking away for good.
The tiny medical device company, unable to find a market for its injectable hydrogel products, is planning to merge with an online-search startup and will become Kwick Search Corp.
The change-over is expected to close by the end of the summer, CEO Marshall Sterman told MassDevice.
The Raynham orthopedics maker, a Johnson & Johnson subsidiary, and Biedermann Motech GmbH sued Medtronic in 2001, accusing it of violating a spinal surgery screw patent DePuy licensed from Biedermann with its now-discontinued Vertex line of multiaxial screws (Medtronic markets the Vertex Select system these days).