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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HeartWare International this week recalled some of its HVAD implantable heart pumps on the risk of electrical faults from driveline contamination.
The recall affects an unspecified number of the left ventricular assist devices, according to an August 15 letter the Framingham, Mass.-based company sent to physicians who implant the pump. Connector contamination of the driveline most often occurred in the 1st 30 days, according to HeartWare, which agreed in June to a $1.1 billion acquisition by Medtronic. Read more
Spectral Medical said today that it plans to file its final pre-market approval module with the FDA for its sepsis treatment by the end of the year, after the impending release of primary endpoint data from a clinical trial.
The Toronto-based company developed a stand-alone pump, the Toraymyxin device, designed for use with an assay to identify endotoxin levels. The system aims to use hemoperfusion to remove septic toxins from the bloodstream. Read more
Becton Dickinson is marking 60 years at its facility in Sandy, Utah, by pledging a $20 million upgrade to the facility, which makes IV catheters and valves, blood collection devices and surgical products.
BD said it bought the site dates back to Deseret Pharmaceutical, which opened in Murray, Utah, in 1956. Franklin Lakes, N.J.-based BD bought the plant in in 1986 and grew it to 550,000 square feet and 1,200 employees. Read more
A legal war erupted this week between sleep apnea device makers ResMed and Fisher & Paykel Healthcare, with lawsuits flying in the U.S., Germany, New Zealand and the U.S. International Trade Commission alleging infringement on both sides.
Fisher & Paykel initiated the hostilities with an August 15 lawsuit in a California federal court, alleging that ResMed’s AirSense 10 and AirCurve 10 flow generators, ClimateLineAir heated air tubing and Swift mask line infringe 11 of its patents. The Auckland, N.Z.-based company moved to withdraw that suit the next day, but reserved the right to sue again, according to documents filed with the U.S. District Court for Central California. Read more
Reports of nearly 40 vascular trauma events – including 19 deaths – with the EnVeo R replacement heart valve delivery catheter prompted Medtronic this month to warn doctors not to force passage if the catheter meets resistance.
The EnVeo R device is used to deliver the Evolut R transcatheter aortic valve replacement via the femoral artery. Although the vascular trauma rate of 0.136% is lower than annular dissection and aortic disruption rates shown in a Journal of the American College of Cardiology registry (0.2% and 0.4%, respectively), Medtronic said the severity of the events triggered a “thorough investigation.” Read more