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.