In collaboration with Cardiothoracic and Vascular Surgeons (CTVS), St. David’s Healthcare participated in the Medtronic PERIGON (Avalus™ valve) Trial. The goal of the study is to determine the safety and effectiveness of the Avalus™ aortic valve bioprosthesis in patients with aortic valve disease. Dr. Faraz Kerendi, Principal Investigator along with other cardiothoracic surgeons from CTVS, performed the surgical procedures for the trial at Heart Hospital of Austin and St. David’s South Austin Medical Center. Patients requiring aortic valve replacement for a diseased, damaged, or malfunctioning native or prosthetic valve were eligible to participate in the study.
When asked about his participation in research studies like PERIGON, Faraz Kerendi, MD, replied, “We are very pleased to be able to provide our patients with access to clinical trials investigating newly developed technology while participating in the clinical trial process to make this new valve available to all patients and physicians.”
This international study began in March of 2014 and by July 31, 2017 had enrolled over 1100 patients worldwide. The study data resulted in FDA approval for commercial use in the United States and CE Mark approval in Europe for the Avalus™ aortic valve. Patients enrolled in the trial will continue to have research appointments for the next 5 years to check on their health and well-being. St. David’s Healthcare is proud to be a part this technological advancement in cardiac surgical devices.