MassDevice.com +3 | The top 3 medtech stories for October 5, 2015

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. Medtronic touts 5-year Valiant stent graft data

Medtronic touted follow-up data from the Valor II study of its Valiant stent graft, saying patients with descending thoracic aortic aneurysms showed 94.8% freedom from aneurysm-related mortality at 5 years.

Fridley, Minn.-based Medtronic, which originally won PMA approval for Valiant in April 2011, said the results show the durability of the Valiant device. The Valor II study, a prospective, single-arm trial involving 160 patients in the U.S., met its primary safety and efficacy endpoints back in 2011 with an overall mortality rate of 12.6% and a 97% success rate at 12 months. Read more

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2. FDA warns St. Jude Medical on CardioMEMS plant in Atlanta

St. Jude Medical revealed that the FDA sent it warning letter after inspections at the Atlanta plant where it makes its CardioMEMS implantable heart monitor turned up problems with its corrective and preventive action plans.

Little Canada, Minn.-based St. Jude said Oct. 2 that the letter, dated Sept. 30, stemmed from inspections at the Atlanta site during June. The federal safety agency issued a Form 483 following the inspections, detailing problems with the way St. Jude documented its CAPA plans. Read more

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1. FDA approves Boston Scientific’s Synergy absorbable stent

The FDA approved Boston Scientific’s Synergy absorbable drug-eluting stent for treating coronary artery disease, sending BSX shares up and making BSX the 1st U.S. entrant on the next front in the stent wars.

The Marlborough, Mass.-based company said the Synergy device, which is made of a bioabsorbable polymer, is designed to dissolve completely after delivering its payload of the anti-restenosis drug everolimus. The stent elutes the drug for about 3 months and is absorbed “shortly” thereafter, Boston Scientific said. Read more

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