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. FDA approves Medtronic’s full-body MRI-safe lead
Medtronic said today that the FDA approved its CapSureFix Novus MRI SureScan 5076 lead in MRI scans for patients with a Medtronic dual-chamber MR-conditional pacemaker.
The 5076 lead was already approved for use with Medtronic’s non-MR-conditional pacemakers, according to a press release. The new approval allows the lead to be paired with the Minneapolis-area medical device giant’s Advisa MRI or Revo MRI SureScan pacemakers. Read more
2. Covidien recalls defibrillator electrodes
Covidien issued a field safety alert on some of its Medi-Trace Cadence and Kendall defibrillation electrodes, saying a connector compatibility issue with defibrillators made by Philips may have contributed to the death of a patient.
The electrodes in question will not connect with Philips FR3 or FRx AED defibrillators and can result in a delay of therapy, according to a press release. Covidien said it received 2 reports in which customers attempted to use a Covidien electrode with a Philips FR3 AED unit, with the mismatch contributing to “a delay in resuscitation” that “may have contributed to the subsequent death of 1 patient.” Read more
1. EuroZone anti-trust regulators to rule next month on $43B Covidien buy
Anti-trust regulators in the European Union set a Nov. 14 deadline for their review of Medtronic’s $43 billion acquisition of Covidien, the European Commission said last week.
The commission will either clear the merger, ask Medtronic to sell off some assets to lessen anti-competitive concerns or launch a more in-depth review. Medtronic and Covidien have said they expect to close the deal late this year or early in 2015. Read more
