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. Denmark’s Ambu pays $16m for ETView Medical
Ambu agreed to pay $16 million to acquire ETView Medical and its portfolio of airway management devices.
The deal calls for Copenhagen-based Ambu to put up $12.3 million in cash and the balance in debt in a “reverse triangular merger” in which Ambu will create a subsidiary, which will buy ETView then be absorbed by Ambu. Read more
4. St. Jude wins CE Mark, launches SyncAV CRT algorithm
St. Jude Medical said today it won CE Mark approval in the European Union and launched its SyncAV CR software algorithm designed to optimize the company’s MultiPoint pacing technology.
The newly released software algorithm is designed to address and treat heart failure patients who are not responsive to other pacing options, and can automatically adjust pacing based on real-time changes in cardiac condition. Read more
3. FDA defends response to late Medtronic Infuse data
The FDA reportedly defended its response to the 5-year delay by Medtronic in reporting results from an internal study of its controversial Infuse bone growth protein, saying it took no action for the late filing because the data was consistent with earlier results on Infuse.
A 2-year internal review of some 3,647 patients implanted with Infuse turned up 1,000 adverse events that should have been reported to the FDA within 30 days. Fridley, Minn.-based Medtronic shut down the review in 2008 but misfiled the data, which it reported to the FDA in 2013 after its rediscovery. Read more
2. Trial slated in wrongful death suit over Norian XR bone cement
A state court in Washington is slated next week to hear the 1st trial in a group of civil lawsuits filed by the families of patients who died on the operating table minutes after injection with the Norian XR bone cement then made by now-Johnson & Johnson subsidiary Synthes.
At least 5 patients died during otherwise routine operations after the Norian cement was used off-label in their spine surgeries. The bone cement was initially developed by a company called Norian, which Synthes bought in 1999 for about $50 million. Synthes, in turn, was acquired by J&J for $21.3 billion in 2012. Read more
1. Nevro takes a hit after insurers deem Senza therapy experimental
Shares in Nevro took a hit yesterday after investors learned that a pair of insurers in Pennsylvania and Tennessee tagged therapy using its Senza spinal cord stimulation device as experimental.
The Senza device, which won an FDA nod in May 2015, is designed to deliver high-frequency electrical impulses of up to 10,000Hz to the spinal cord to avoid the tingling sensation known as paresthesia that bothers some SCS patients. The FDA approval allows Redwood City, Calif.-based Nevro to label the device’s HF10 therapy as superior to conventional spinal cord stimulators. Read more
The post MassDevice.com +5 | The top 5 medtech stories for June 23, 2016 appeared first on MassDevice.
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