Edwards Lifesciences has successfully completed the first minimal-access, beating-heart surgical procedure for replacing a patient's aortic valve. Edwards is planning on developing the Ascendra aortic heart valve replacement system as an additional option for valve surgery.
A medical team from St Paul's Hospital in Vancouver, British Columbia, used Edwards' proprietary Cribier-Edwards percutaneous heart valve to perform trans-apical placement (TAP), a beating-heart procedure in which a sutureless, stent-mounted aortic valve is delivered through a mini-incision between the ribs. The first TAP procedure was performed at St Paul's by Dr Samuel Lichtenstein, director of cardiovascular surgery, and Dr John Webb, director of interventional cardiology.
The balloon-mounted valve was compressed to the approximate diameter of a pencil, then inserted through a small incision between the ribs and delivered through the bottom apex of the heart to be deployed inside the native valve. While traditional aortic valve replacement surgery requires opening the patient's chest, stopping their heart, and managing their circulation on cardiopulmonary bypass for at least an hour, the first TAP procedure was completed on a beating heart less than 30 minutes after the surgical mini-incision was made.
The TAP procedure with the Edwards Ascendra valve system was developed in partnership with surgical teams led by Dr Michael Mack of Medical City, Dallas; Dr Friedrich Mohr of Leipzig, Germany; and Dr Gerhardt Wimmer-Greinecker of Frankfurt, Germany.
Edwards' Ascendra system is not yet commercially available, and the company plans to continue to evaluate its feasibility in European and Canadian studies in 2006. Results from these studies will determine timelines for a future pivotal study intended to achieve commercial clearance in key global markets.
|
