Medtronic Launches Avalus Ultra Aortic Valve in Western Europe
Key Insights
Medtronic has launched the Avalus Ultra Bioprosthesis valve (search) in Western Europe, designed for ease of use during implantation and enhanced patient management.
The Avalus Ultra valve features a low profile, PEEK base frame, and radiopaque coil for clear visibility during potential TAV-in-SAV procedures.
The first implantation in Western Europe occurred in Leipzig, Germany, with successful minimally invasive aortic valve replacements (search).
Medtronic has announced the Western European launch of its Avalus Ultra Bioprosthesis valve (search) at the European Association for Cardio-Thoracic Surgery (EACTS) annual congress in Lisbon. This valve is engineered for simplified implantation and improved long-term patient care, building on a decade of clinical experience with the original Avalus valve (search).
The Avalus Ultra valve incorporates features designed to enhance usability during implantation, provide clear visibility for potential TAV-in-SAV (transcatheter aortic valve (search) implantation in surgically implanted valve) procedures, and maintain industry-leading Effective Orifice Areas (EOA) while ensuring long-term durability, leveraging the clinical data from the Avalus valve (search).
Key features of the Avalus Ultra surgical valve include:
- A low valve profile to facilitate ease of implantation, coupled with industry-leading EOA to potentially improve blood flow, supported by Avalus valve clinical evidence.
- A polyetheretherketone (PEEK) base frame, providing a robust foundation to maintain valve circularity over time.
- A radiopaque coil, enhancing fluoroscopic visibility for potential TAV-in-SAV procedures.
"We are thrilled to further expand access to the Avalus Ultra valve by launching in Western Europe at the prominent EACTS annual congress," stated Karim Bandali, Ph.D., president of the Cardiac Surgery business within the Cardiovascular Portfolio at Medtronic. He also noted that the Avalus Ultra valve launch follows other recent innovations, including the Penditure Left Atrial Appendage (LAA) Exclusion System and the VitalFlow Extracorporeal Membrane Oxygenation (ECMO) system.
The first implantation of the Avalus Ultra valve in Western Europe took place at the Heart Center in Leipzig, Germany. Professor Michael Borger and his team successfully performed two aortic valve replacements (search) using the Avalus Ultra valve via minimally invasive techniques.
Data from the PERIGON Pivotal Trial, a prospective study involving over 1,123 patients across 39 centers in eight countries, were presented at EACTS. The trial evaluated the Avalus valve (search) over seven years.