`and Announces Plans to Initiate Expanded Clinical Evaluation
`
`CoreValve’s ReValving™ System is the first cath lab-based procedure for
`percutaneous aortic valve replacement to receive European regulatory clearance
`
`May 16, 2007 09:46 AM Eastern Daylight Time
`
`IRVINE, Calif.--(BUSINESS WIRE)--CoreValve (www.corevalve.com) announced today that it has received CE Mark
`approval of its CoreValve Percutaneous ReValving™ System for treatment of high-risk patients. The patented
`ReValving™ System consists of a novel porcine pericardial tissue valve mounted in a self-expanding multi-level frame,
`which is permanently implanted over the diseased aortic heart valve by an 18-French-sized catheter. The small size of the
`delivery catheter is a key element of the system as it greatly improves overall maneuverability and valve placement while
`also eliminating the need for surgical cut-down of the femoral artery.
`
`CoreValve also announced that it will not immediately market the ReValving™ System. Rather, the Company will proceed
`with an expanded clinical evaluation at a small number of select international centers to help ensure that interventional
`cardiologists are well trained, that patients are appropriately selected for treatment, and that appropriate clinical feedback
`is obtained. CoreValve has established a mandatory expanded clinical evaluation patient registry to gather additional
`clinical data for submission to the FDA in support of clinical trials and regulatory approval in the USA.
`
`About CoreValve
`
`Founded in 2001, privately held CoreValve—which is headquartered in Irvine, California—has developed a proprietary
`delivery system and tissue heart valve for percutaneous heart valve replacement. Based on a novel catheter-and-self-
`expanding-frame approach on a beating heart, the proprietary CoreValve ReValving™ System procedure is intended to
`avoid open-heart surgery. It can be performed in a cardiac “cath lab” just like angioplasty and stenting, which may result in
`less trauma to the patient and may offer substantial cost-savings to the healthcare system. 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 commercialization
`until further notice.)
`
`Contacts
`Ronald Trahan Associates Inc.
`Ronald Trahan, APR, 508-359-4005, x108
`
`/
`
`Edwards Lifesciences Corporation, et al. Exhibit 1027, p. 1 of 2
`
`
`
`/
`
`Edwards Lifesciences Corporation, et al. Exhibit 1027, p. 2 of 2
`
`
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