New data presented for the first time at the World Heart Federation’s World Congress of Cardiology 2014 shows a significant improvement in both patient adherence and risk factor control when patients at high risk of heart attack or stroke receive a polypill, compared to usual care. 

Kalila Medical received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Vado steerable introducer sheath used during atrial fibrillation (AF) and other procedures requiring vascular and intracardiac access.

IABP, Datascope, Maquet, FDA recall

Datascope Corp./Maquet initiated a voluntary worldwide field correction of some of its intra-aortic balloon pumps (IABPs) due to a potential mechanical failure of the fan assembly associated with the power supply. All customers that may have an IABP affected by this field correction have been notified. The company says there are about 12,360 affected units sold globally.
MassMEDIC ACA Medical Device Tax Innovation

Medical device executives from across the region are not sure the influx of new patients using their devices and the promised sales boost expected from the Affordable Care Act (ACA) will offset the costs of the ACA’s medical device tax, according to a new survey analysis presented to more than 350 medical technology leaders at UMass-Boston at the Massachusetts Medical Device Industry Council’s (MassMEDIC) 17th annual conference.

InspireMD Inc. initiated a Voluntary Field Action (VFA) following recent reports of MGuard Prime EPS (embolic protection systems), stent dislodgements. 

A quarter century ago, doctors treating patients with implanted cardiac pacemakers had a big problem. Their patients were outliving the complex electrical devices that gave them an acceptable quality of life.

 

May 8, 2014 — Abbott announced its catheter-based MitraClip therapy has received Health Canada approval, providing physicians in Canada with the treatment option that can significantly improve symptoms, disease progression and quality of life for certain people with mitral regurgitation (MR).


May 8, 2014 — The past year has been a turbulent one for U.S. physicians, according to the 2014 Practice Profitability Index (PPI). Approximately 5,064 physicians contributed their insights to the second annual PPI in March 2014.
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