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. Fire & Ice: Medtronic’s Arctic Front ablation catheter as good as BioSense Webster’s ThermoCool
Results from a clinical trial presented today at the annual meeting of the American College of Cardiology showed that the Arctic Front ablation catheter made by Medtronic is noninferior to Johnson & Johnson subsidiary BioSense Webster‘s ThermoCool device in treating atrial fibrillation.
The Fire & Ice study compared Arctic Front’s cryoballoon ablation technique with the radiofrequency ablation used by the ThermoCool device in a total of 762 patients for a mean duration of 1.5 years. The results, presented today in Chicago and published in the New England Journal of Medicine, showed that the Arctic Front catheter met its safety and efficacy endpoints in the trial. Read more
4. FDA clears CardioFocus’ HeartLight ablation system
CardioFocus said today it won FDA premarket approval for its HeartLight endoscopic ablation system, indicated for treating drug refractory recurrent symptomatic paroxysmal AF.
The approval is based on data from a 353-patient, multi-center pivotal clinical study which met the primary safety and efficacy endpoints and reported freedom from paroxysmal AF at 12 months post-procedure, the Marlborough, Mass.-based company said. Read more
3. Medtronic touts more early data from drug-filled stent study
Medtronic yesterday touted early data from a clinical study of its drug-filled stent aimed at winning CE Mark approval in the European Union.
The DFS is built using the Fridley, Minn.-based medical device giant’s Resolute Integrity and Resolute Onyx stents, using its “continuous sinusoid” and CoreWire technologies. It’s made with a “tri-layer” wire design in which the innermost layer is removed, leaving an empty space that’s lined with the anti-restenosis drug sirolimus. The drug is delivered via laser-drilled holes on the outer surface of the stent, designed for sustained elution directly into the arterial wall over a set period of time. Read more
2. Edwards Lifesciences touts intermediate-risk data for Sapien devices
Data from a large trial of the Sapien line of replacement heart valves made by Edwards Lifesciences are slated to be used to back bids for expanded indications in intermediate-risk patients.
Presented over the weekend at the American College of Cardiology’s annual meeting in Chicago, results from the Partner II trial involving the Sapien XT and Sapien 3 transcatheter aortic valve replacements compared the TAVR treatments with traditional open surgery in the intermediate-risk cohort (both of the Edwards valves are already approved in the U.S. for high-risk patients). Read more
1. AngioDynamics CEO DeVivo out, ex-Covidien exec Clemmer in
AngioDynamics said that president & CEO Joseph DeVivo stepped down to “pursue other interests” and was replaced by ex-Covidien bigwig James Clemmer, effective today. Read more
The post MassDevice.com +5 | The top 5 medtech stories for April 4, 2016 appeared first on MassDevice.
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