CoreValve Reports it has certified its Irvine, Calif. clean room operations

IRVINE, Calif. & PARIS–(BUSINESS WIRE)–May 16, 2005–CoreValve announced today that it has completed the certification of the Company’s two ‘clean rooms’ at its R&D and manufacturing facility based in Irvine, Calif.

The 8,500-square-foot Irvine operation is a state-of-the-art research, development and manufacturing facility–with microbiology, biochemical, tissue fixation, and tissue-heart valve production capabilities. CoreValve is focusing its proprietary development and manufacturing programs–i.e., its ReValving(TM) frame, its tissue heart valve and valve-to-frame assembly, as well as its loading and delivery catheter systems assembly–in this specialized facility. The Irvine ‘clean rooms’ are to be used for separate prosthesis and catheter production.

“We are in the final stage of completing our proprietary design of a novel pericardial valve, specifically intended for percutaneous delivery. The importance of this event to the interventional cardiology community is that our upcoming European clinical trial will be initiated with this new valve design–which will reduce the diameter of our delivery catheter to less than 21French size. This facility certification is the first step toward fabricating our second-generation ReValving System for clinical trial use,” said Rob Michiels, President of CoreValve USA.

“This milestone keeps CoreValve on schedule to commence a Phase II clinical trial later this year to meet our European CE-Marking objective,” added Dr. Jacques Seguin, founder, chairman and CEO of CoreValve. “The decision to design our own tissue valve and build it in-house on CoreValve’s patented frame is to optimize design and mounting so as to enhance valve durability–and make it comparable, if not superior, to surgical prostheses.”


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