Say hello to MassDevice +3, a bite-sized view of the top three medtech 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.
3. Jury hits Wright Medical with $11m verdict in Conserve hip implant bellwether
A federal jury in Georgia handed an $11 million loss to Wright Medical in the 1st bellwether trial in the multidistrict litigation filed over its Conserve metal-on-metal hip implant.
The Atlanta jury awarded plaintiff Robyn Christiansen $1 million in compensatory damages and another $10 million in punitive damages, Christiansen’s lawyers said. The jury found Nov. 24 that the Conserve device defective and that Wright failed to adequately warn patients about its risks. Read more
2. St. Jude Medical’s Proclaim Elite debuts in Europe
St. Jude Medical said that it’s launching its Proclaim Elite spinal cord stimulation device in the European Union after winning CE Mark approval there, including an indication for conditional MR labeling for the Proclaim Elite for head and extremity scans.
The approval also covers St. Jude’s “burst stimulation” technology, which is designed to reduce the sensation of tingling along the spinal cord associated with tonic stimulation called paresthesia, according to the Little Canada, Minn.-based company. Read more
1. FDA deems Boston Scientific’s atherectomy component recall Class I
The FDA slapped Class I status on Boston Scientific’s recall of nearly 1,000 components used with its Rotablator atherectomy device.
Boston Scientific warned doctors of the potential problem in October, after receiving 3 reports that the catheter’s guidewire fractured during procedures to remove plaque from the coronary arteries. In 1 case, the patient died 4 days after the wire fractured and the device’s rotating burr, moving at 195,000 to 200,000 rpm, pierced the artery wall, according to the FDA’s adverse events database. Read more
The post MassDevice.com +3 | The top 3 medtech stories for November 30, 2015 appeared first on MassDevice.
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