January 17, 2014 — Cardiothoracic and Vascular Surgeons (CTVS) is the first practice in Texas to implant a Sorin Perceval S self-anchoring aortic heart valve as part of a new clinical trial. John Oswalt, M.D., and Faraz Kerendi, M.D., both cardiothoracic surgeons with CTVS, performed the procedure on two patients at Heart Hospital of Austin. CTVS is one of 25 sites around the country taking part in the study. The Perceval S valve has already been approved for use in Europe, and over 58 patients have already received the valve in the United States. The surgical procedures performed by CTVS and other sites during this trial will be used to help pave the way for U.S. Food and Drug Administration (FDA) clearance of the Perceval S valve in the United States.
“We are delighted to begin the process of bringing this cutting-edge technology to patients in the U.S.,” said William Kessler, cardiothoracic surgeon, CTVS, and principal investigator for the study in Austin. “Because it is a sutureless valve, it could be particularly ideal for medium to high-risk patients with aortic stenosis. We can implant the valve using a minimally invasive approach, so the valve replacement is potentially less traumatic for the patient and could result in a faster recovery.”
The Perceval S valve is designed to replace both native aortic valves and other aortic prosthetic devices. The valve is made from a bovine pericardium sewn to a super elastic alloy frame. This allows the Perceval S valve to self-adjust to each individual’s heart without a surgeon attaching it to the wall of the heart with sutures. It is designed to enable the surgeon to use minimally invasive techniques when implanting the Perceval S valve, which has the potential to reduce time in the operating room. Minimally invasive surgery has been shown to reduce patient time under anesthesia and post-operative complications.