Medtronic CoreValve System shows long-term efficacy and durability in pivotal trial

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New clinical data presented on 26 May 2010 at EuroPCR demonstrate positive long-term performance and durability for the CoreValve transcatheter aortic valve replacement system (Medtronic). Two-year results from the pivotal 18F CoreValve multicentre prospective study provide important additional evidence supporting wider use of the CoreValve transcatheter aortic valve.

The CoreValve system received CE mark in March 2007. It is not yet available in the USA for clinical trial or commercial sale or use.

 

The CoreValve system, designed to replace a diseased aortic valve without open-heart surgery or surgical removal of the native valve, has now been implanted in more than 10,000 patients worldwide in 32 countries outside the USA. Typically delivered through the femoral artery, CoreValve is used in 75% of transarterial transcatheter valve replacement procedures.

 

“These pivotal trial results provide important evidence and confidence to physicians that CoreValve is an effective long-term treatment alternative for many patients with severe aortic stenosis who are considered at high surgical risk or inoperable,” said Ulrich Gerckens, Helios Heart Center Siegburg, Siegburg, Germany. “Without valve treatment this patient population faces a 50% chance of survival from cardiovascular events at two years. In contrast, patients who received CoreValve have a greater chance of survival and overall better heart function.”

 

The study evaluated 126 patients at nine centres in Europe and Canada who were implanted with the currently marketed 18F CoreValve system. Investigators reported the following study results:

  • Two-year effectiveness data: About three quarters (73%) of patients saw their heart failure symptoms improve substantially (one or more NYHA class improvement). Valve opening area increased 2.5 times from baseline on average and remained stable at two years. Resistance to forward flow through the valve (peak and mean valve gradient) was decreased by 75 to 80%.
  • Two-year survival data: Two-year cardiac survival was 74%.
  • Two-year valve performance: Over two years, no valve migrations or valve deterioration occurred.
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