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Medtronic CoreValve System Shows Efficacy In Pivotal Trial

Medtronic has presented new clinical data at EuroPCR that demonstrated positive long-term performance and durability of the CoreValve transcatheter aortic valve replacement system.

The two-year results from the pivotal 18-French CoreValve multicenter prospective study provided additional evidence supporting wider use of the transcatheter aortic valve. The CoreValve system received CE (Conformite Europeenne) mark in March 2007. It is not yet available in the US for clinical trial or commercial sale or use.

The study evaluated 126 patients at nine centers in Europe and Canada who were implanted with the currently marketed 18F CoreValve system. The study results include that about three quarters (73%) of patients saw their heart failure symptoms improve substantially (one or more NYHA class improvement).

In the study, the 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 cardiac survival was 74% and over two years, no valve migrations or valve deterioration occurred.

John Liddicoat, cardiac surgeon and vice president and general manager of the structural heart division, part of the CardioVascular business at Medtronic, said: “These trial results reinforce the significance of Medtronic’s strong commitment to help many of the 300,000 people worldwide who suffer from severe aortic stenosis.

“We are proud of these long-term performance results and to have reached the milestone of 10,000 CoreValve procedures. We look forward to bringing this therapy to many more patients in need.”

Ulrich Gerckens of HELIOS Heart Center Siegburg in Germany, said: “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.

“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.”