Amid lawsuits concerning its Pinnacle metal-on-metal hip implant, Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics won U.S. Food & Drug Administration clearance for its next-generation Pinnacle ceramic-on-metal hip implant.
Ceramic-on-metal is a novel combination in the hip implant market, having undergone two-year controlled, randomized, multicenter, non-inferiority clinical study and laboratory testing as part of the clearance process.
The study found no clinical difference between 194 patients who received JNJ’s new ceramic-on-metal system and 196 patients in a control group who received metal-on-metal implants, according to the FDA release.
DePuy is already under a differently hued spotlight for ongoing lawsuits against its previous generation of metal-on-metal Pinnacle hip implant systems over findings that they shed minute metal particles into a patient’s bloodstream as the hip’s ball joint wears on the metal cup.
The lawsuit, a consolidation of 57 different suits against the implants, also include DePuy’s ASR hip implant and allege that the New Brunswick, N.J.-based medical conglomerate knew of problems with the implant but left it on the market anyway.
DePuy voluntarily recalled the ASR implant in August 2010 after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.
The FDA filed a permanent injunction banning Wisconsin-based H&P Industries Inc. from making or distributing any medical products after repeated sterility problem with its products.
The company said it has reached an agreement with the FDA to hire an outside consultant, hoping to resume operations once the consultant and the FDA agree that H&P
meets federal guidelines.
U.S. Marshals seized the company’s products in April and released an inspection report indicating that the facilities were still rife with contamination. The FDA issued a consent decree consisting of a permanent injunction, condemnation and forfeiture against H&P this week.
H&P has issued five voluntary recalls since January, covering wipes, prep pads and swabs sold under the Triad name and commonly used in hospitals and packaged with a number of medications. The products were also sold under other labels, including CVS, Walgreens and Cardinal Health.
Inspections found that products were contaminated with Bacillus cereus, a bacteria responsible for about two percent of all foodborne illnesses, at company’s Hartland, Wis., manufacturing facility.
Endologix, Inc. (NSDQ:ELGX), developer of minimally invasive treatments for aortic disorders, announced FDA clearance for its next-gen AFX system for treatment of abdominal aortic aneurysms. AFX is the lowest profile device currently approved for treatment of the most common AAAs in the U.S., officials of the Irvine-Calif.-based company said.
Israeli patient monitoring system developer EarlySense Ltd. touted both U.S. regulatory clearance and CE Mark approval in the European Union for a wireless network option on its contact-free patient monitoring solution. The system wirelessly connects bedside units to a central display system at the nurse’s station.
Hovione announced an international patent filing for its new dry powder inhaler, which combines high efficiency in powder dispersion and only takes two steps to use. The Portuguese company works in active pharmaceuticals development and compliance manufacturing.
W.L. Gore & Associates won Canadian approval for its SeamGuard bioabsorbable staple line reinforcement device, engineered to reduce leaks and bleeding during a variety of open and minimally invasive surgeries. More than 500,000 successful implants have been completed and more than 40 clinical papers have documented its use, officials of the Flagstaff, Ariz.-based company said.
Pathway Medical Technologies Inc. announced its second FDA win this month, this time for its Jetstream G3 SF catheter for treatment of peripheral vascular disease. The Kirkland, Wash.-based company won FDA clearance for its Jetstream Navitus last week.
Ventana Medical Systems announced FDA clearance for its Inform HER2 breast cancer gene diagnostic assay, the first fully automated assay of its kind cleared for marketing in the U.S.
Tokyo-based Varian Medical Systems Inc. (NYSE:VAR) won Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its TrueBean image-guided radiotherapy and radiosurgery system.
Portsmouth, N.H.-based Salient Surgical Technologies announced that it won FDA clearance for its disposable Aquamantys bipolar sealer, intended for use in blunt dissection, which helps surgeons prevent and stop bleeding of soft tissue and bone during surgery.
Endosphere Inc., maker of an implantable and incisionless weight loss device, announced that the U.S. Patent and Trademark Office issued the Colombus, Ohio-based company a patent for its endoscopically implantable obesity treatment devices.
Maquet Cardiovascular LLC won FDA 510(k) clearance for its Flow-i anesthesia system covering a variety of models. The Swedish company was recently forced to recall its Heartstring II proximal seal system, which helps control blood flow in the aorta during surgery.
Fenwal Inc. announced CE Mark approval in the EU for a therapeutic plasma exchange component for the Lake Zurich, Ill.-based company’s Amicus system, which separates cells as blood is drawn from a patient. The new component removes substances from the blood that can cause or complicate disease.
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