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Medtronic Acquires Non-Surgical Aortic Valve Technologies
Purchase of CoreValve and Ventor Targets Leadership Role in High-Growth Aortic Transcatheter Valves

February 28, 2009 -- Medtronic, Inc. (NYSE: MDT) announced this week that it is acquiring two privately held companies that have been in the forefront of development for transcatheter aortic valves. The move, estimated at slightly more than $1 billion, positions Medtronic to move forward with future development and clinical trials of these non-surgical approaches to aortic valve replacement, a field currently occupied by Edwards LifeSciences.

CoreValve, Inc. located in Irvine, California, has developed the ReValving System which received European CE Mark approval in May 2007. The ReValving System comprises a porcine pericardial tissue valve, mounted on a self-expanding frame and implanted via an 18F delivery catheter percutaneously through the femoral artery. Medtronic notes that the CoreValve ReValving System is not currently available in the USA for clinical trials or for commercialization. Non-USA clinical evaluation has been in progress for several years. In this exclusive interview from 2007, Dr. Eberhard Grube of Siegburg, Germany, discusses his experience with non-surgical valves.     Eberhard Grube, MD, FACC (7:50)

The second acquisition by Medtronic of Israeli-based Ventor Technologies Ltd. involves a valve inserted not through the femoral artery, but transapically, through a small incision in the rib cage. This method can be used when the femoral artery may not be suitable, because of peripheral disease or other clinical conditions.

Like the CoreValve, the Ventor Embracer System is also not currently available in the USA for clinical trials or for commercialization.

Approval is needed from the FDA to begin U.S.-based clinical trials for these devices -- some physicians believe that may happen this year although, according the the Wall Street Journal, it will be at least until 2014 for the CoreValve to become available in the U.S.

Percutaneous or transcatheter aortic valve replacement is specifically targeted for patients who are too frail or sick to withstand major heart surgery, which is currently the only available method of valve replacement. It is possible that with experience and long-term results, the delivery of a heart valve through the femoral artery may extend to younger and healthier patient populations.

The development of these technologies is yet another way in which Andreas Gruentzig's original concept of working safely inside the arteries of an awake patient has been expanded to treat a multitude of conditions, from coronary artery disease, aortic aneurysms, kidney disease and now heart valves.

Reported by Burt Cohen, February 28, 2009