Medtronic has announced CE mark and FDA approval of its new Avalus pericardial aortic surgical valve for the treatment of aortic valve disease. According to a press release, valve leverages proven surgical bioprosthetic valve concepts with added features designed to enhance clinical performance, helping to address the contemporary needs of cardiac surgeons and patients.
The press release also reports that the Avalus valve is the latest addition to Medtronic’s robust portfolio of innovative heart valve therapy solutions. In addition to being the only stented surgical aortic valve on the market that is MRI-safe (without restrictions), it is designed for excellent implantability, an important factor during complex cases.
Robert Klautz (Leiden University Medical Center, The Netherlands) says: “The proven design elements of the Avalus valve were selected with physicians and patients in mind striving to improve upon the latest generation of stented tissue valves while maintaining the gold standard in cardiac surgery. Based on my early clinical experience, the unique design elements of the Avalus valve position it well toward meeting the expectations of durability for new tissue valves and helps ease implantation in a wide range of patient anatomies.”
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-randomised, prospective study of more than 1,100 patients from approximately 40 clinical sites across Europe, Canada and the USA. Results from the trial were recently presented by Joseph Sabik (UH Cleveland Medical Center, USA) 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 haemodynamic performance at one year. Patients enrolled in the trial will be followed out to five years.
The Avalus valve will be commercially available later this year.