Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
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5. Lombard expands EU launch of Altura AAA endograft system
Lombard Medical Technologies said today it expanded the European launch of its Altura endovascular stent graft to the Netherlands and Spain, touting 4 completed procedures with the device in the newly expanded regions.
The Altura endograft system is designed as a transcatheter treatment for abdominal aortic aneurysms, and can be repositioned during deployment to allow for the utilization of the available aortic neck, the company said. Read more
4. NeoCoil recalls Flex Speeder MRI device on burn risk
Magnetic resonance imaging radiofrequency coil developer NeoCoil said it is recalling its 3 tesla 16 channel Flex Speeder large coil due to an increased burn risk.
The company said that the recall was initiated due to “the potential for higher than specified surface temperatures,” which could result in patient warming or burns. Read more
3. J&J’s DePuy can’t delay 3rd bellwether in Pinnacle hip MDL
A Johnson & Johnson subsidiary can’t delay an upcoming bellwether trial in the multi-district litigation over its Pinnacle metal-on-metal hip implant, a federal judge in Texas ruled yesterday.
DePuy Orthopaedics asked Judge Ed Kinkeade of the U.S. District Court for Northern Texas for a stay of the 3rd bellwether trial in the MDL, which involves more than 8,000 cases. The company also asked a federal appeals court to hit the pause button to give it enough time to appeal a $500 million jury verdict in the 2nd bellwether. DePuy wanted Kinkeade to pause the 3rd bellwether while the the U.S. Court of Appeals for the 5th Circuit considers its petition for a writ of mandamus. Read more
2. FDA warns Zimmer Biomet over quality system issues at Montreal plant
The FDA warned Zimmer Biomet in May about a series of quality system violations the federal safety watchdog flagged during January inspections of a plant in Montreal.
The plant makes the iAssist and Zimmer PSI knee systems, the Zimmer PSI shoulder and the Navitrack software system, according to a warning letter dated May 27 and released June 30. The FDA said the inspections, from January 25 through January 28, turned up 9 quality system violations that were issued in a Form 483 notice. Zimmer Biomet responded in February and March, but the March 31 letter missed the 15-business-day deadline and was not reviewed (the agency said it would take a look at it when it reviews the company’s response to the warning letter). Read more
1. Merit Medical pays $98m for DFine’s spine devices
Merit Medical said today that it paid $97.5 million in cash to acquire DFine and created a new division to incorporate DFine’s spine devices.
San Jose, Calif.-based DFine makes the StabiliT line of devices, for injecting bone cement into vertebral fractures, and the Star spine tumor ablation system. Jordan, Utah-based Merit said its new interventional oncology & spine division will unite those products with its own line of oncology devices, including embolics, microcatheters and biopsy products. Read more
