The FDA issued a safety alert after receiving reports of more than 100 adverse events, including 9 patient deaths, that may have been caused by Onyx brain blood vessel plugs made by Covidien (NYSE:COV) subsidiary ev3 Inc.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
The FDA’s neurological devices panel will review clinical data from trials of Stryker’s (NYSE:SYK) Wingspan brain stent system next month, aiming to address harsh criticisms and public petitions urging the agency to recall the device.
The panel plans to consider pre-market and post-market data about the device, including the Gateway PTA balloon catheter and stent delivery system, to address concerns that Wingspan may lead to heightened risk of stroke or death.
A federal study of a new stent designed to prevent repeat strokes was stopped early because 2 1/2 times (14.7%) more people either died or had a repeat stroke after receiving the stent than those who received drugs and counseling (5.8%).
The $20 million study, stopped after just 451 stroke victims had been enrolled because of the alarming trend in the results, was sponsored by the National Institute of Neurological Diseases and Stroke.
Stroke patients who received artery-widening brain stents had higher rates of stroke and death than patients who took only medication and received lifestyle change advice, researchers said.
High-risk patients treated with blood thinners and lifestyle coaching had lower rates of stroke and death than those who received Stryker Corp.’s (NYSE:SYK) Wingspan brain stent in addition to the medication and guidance, but researchers aren’t ready to give up on the technology just yet.
Stryker Corp. (NYSE:SYK) agreed acquire Concentric Medical Inc. for $135 million in cash in a deal expected to close by the end of the year.
Stryker Corp. (NYSE:SYK) says a new clinical trial proves that its Matrix detachable coil devices are as effective as an older version of a catheter-fed coil, which has been on the market for more than 15 years.
Researchers said the company’s Matrix Detachable Coils were as effective as GDC detachable coils in treating ruptured and unruptured aneurysms in results from the Kalamazoo, Mich.-based company’s Matrix and Platinum Science or MAPS trial.
NeuroSigma Inc. spun out NSVascular Inc. to develop two stent lines using thin-film nitinol technology developed at the University of Calif.-Los Angeles under an exclusive licensing agreement.
Los Angeles-based NeuroSigma said its new subsidiary plans to develop one type of stent to treat brain aneurysms and another to treat peripheral artery disease.
Covidien plc (NYSE:COV) will take its Solitaire FR revascularization device directly to regulators rather than wait for additional clinical data, after an independent panel’s review of the data collected so far.