CoreValve announces that more than 1,000 high-risk patients have been
treated with its ReValving® System
for percutaneous aortic valve replacement (PAVR)
Highly encouraging registry data also presented at EuroPCR 2008
IRVINE, Calif. (Business Wire EON/PRWEB ) May 15, 2008 --
CoreValve (www.corevalve.com) announced
today that the expanded clinical evaluation of its ReValving®
System for percutaneous aortic valve replacement (PAVR) in
high-risk patients with aortic stenosis continues to enroll patients at
an accelerating pace. These procedures can be performed under local
anesthesia, without the need for surgical cutdown/repair, and without
hemodynamic support or artificially accelerating the heart rate.
Also at the meeting, Maurice Buchbinder, MD (San Diego, Calif.),
and Patrick Serruys, MD, PhD (Rotterdam, The Netherlands)
presented clinical data from the ongoing post-CE Mark expanded clinical
evaluation registry at the EuroPCR 2008 cardiovascular intervention
meeting taking place in Barcelona, Spain. One-month post-procedure, 92
percent of the high-risk and often inoperable octogenarian patients
were alive and well and only nine percent needed subsequent pacemaker
implantation. Quality-of-life improvements endured in patients followed
up to six months.
“We are highly encouraged by the robust and
durable clinical trial and registry data presented at this medical
meeting,” added Daniel T. Lemaitre,
President and CEO of CoreValve. “Additionally,
the 1000-patient milestone, confirms the presence of a significant
patient population who can benefit from this groundbreaking technology.”
About CoreValve
CoreValve, Inc., is headquartered in Irvine, Calif. Its proprietary ReValving®
System allows both percutaneous aortic valve replacement (PAVR)
and transapical aortic valve replacement (TAVR) and is intended
to provide an alternative to open-heart surgery. The ReValving®
System procedures are performed on the beating heart without cardiac
assistance or rapid pacing, and may result in less trauma to the
patient. This technology may also offer substantial cost-savings to the
healthcare system. The catheter-based technology includes a proprietary
framed/self-expanding tissue heart valve that is specifically designed
and engineered for transcatheter delivery. For more information about
CoreValve, visit the Company’s Web site at www.corevalve.com.
(Caution: the CoreValve ReValving®
System will not be available in the USA for clinical trials or for sale
until further notice.)
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