Main > CARDIOLOGY (**) > IE. M. Products> > >Valves>Aortic>Replacement> > >(*) FDA OK: 2014. 06.12>

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for Patients at High Risk for Surgery

Accelerated Approval Obtained after Clinical Outcomes with Self-Expanding Valve Prove Superior to Surgical Aortic Valve Replacement at One Year

ystem Now Available to More U.S. Patients than any Other Transcatheter Aortic Valve

FDA Approval self-expanding transcatheter RTM System for patients with severe aortic stenosis who are at high risk for surgery.

The RTM System was approved by the FDA for patients at extreme risk in January 2014.

The FDA approved the entire RTM platform - including the 23mm, 26mm, 29mm and 31mm size valves - all of which are delivered through the smallest commercially available TAVR delivery system (18Fr, or approximately 1/4 inch), making it possible to treat patients with difficult or small vasculature.

EU>OK: 2007


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