Medtronic today announced FDA approval and European CE marking of the company’s Avalus pericardial aortic surgical valve. The device is currently the only stented surgical aortic valve that does not limit patients’ ability to undergo MRI scans, and whole body scans are allowed as there are absolutely no restrictions and no related safety concerns.
The valve features a supra-annular design that helps to reduce blood regurgitation through the center of the device, a leaflet and frame design that is interior-mounted to help increase its lifetime, an overall low profile and narrow valve holder, as well as a simple to use release mechanism that makes positioning of the valve a snap.
Some details about the study that led to the regulatory approvals, according to Medtronic:
The CE Mark and FDA approval of the Avalus valve is based on subsets of data from the PERIGON Pivotal Trial, a single arm, non-randomized, prospective study of more than 1,100 patients from approximately 40 clinical sites across Europe, Canada and the United States. One of the largest, most comprehensive and modern data sets of surgical aortic valve replacement (SAVR) patients, results from the trial were recently presented by Dr. Joseph Sabik of the UH Cleveland Medical Center at the American Association of Thoracic Surgery (AATS) annual meeting in Boston, and showed low rates of adverse valve-related events, high survival and improved hemodynamic performance at one year. Patients enrolled in the trial will be followed out to five years.