Medtronic
Medtronic plc, a global leader in healthcare technology, has announced the launch of the Avalus Ultra Bioprosthesis valve in Western Europe during the European Association for Cardio-Thoracic Surgery (EACTS) annual congress in Lisbon. The Avalus Ultra valve, engineered for ease of use at implant and lifetime patient management, is Medtronic’s most advanced surgical aortic tissue valve built on 10 years of clinical experience with the Avalus valve.
The Avalus Ultra valve brings ease of use at implant, clear visibility for potential TAV-in-SAV procedures, and industry-leading Effective Orifice Areas (EOA) with long-term valve durability based on a decade of clinical experience with the Avalus valve.
More specifically, Medtronic says the Avalus Ultra surgical valve has:
- A low valve profile designed to facilitate ease of use at implant with industry-leading EOA that may allow for greater blood flow that is supported by the clinical evidence of the Avalus valve
- A polyetheretherketone (PEEK) base frame, which provides a durable foundation to maintain valve circularity
- A radiopaque coil for clear 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,” said Karim Bandali, Ph.D., president of the Cardiac Surgery business within the Cardiovascular Portfolio at Medtronic. “The Avalus Ultra valve launch builds on several successful innovation launches this year, including the acquisition and launch of the Penditure Left Atrial Appendage (LAA) Exclusion System and the VitalFlow Extracorporeal Membrane Oxygenation (ECMO) system, making Medtronic Cardiac Surgery the most robust cardiac surgery portfolio offering available today.
"This further demonstrates the company’s commitment to boldly invest in innovation across multiple cardiovascular and respiratory therapies to advance treatment options for more complex disease, and address clinicians’ growing need for managing patients holistically over their lifetime.”
The first implantation of the Avalus Ultra valve in Western Europe occurred last week at the Heart Center in Leipzig, Germany, where Professor Michael Borger and his team successfully conducted two aortic valve replacements using the Avalus Ultra valve through minimally invasive access.
Additionally, at EACTS the 7-year outcomes from the PERIGON Pivotal Trial for the Avalus valve will be presented on Friday, Oct. 11th. According to Medtronic, the PERIGON Pivotal Trial is the largest prospective study of any contemporary stented surgical valve with more than 1,123 patients at 39 centers across eight countries. The Avalus Ultra valve is built on a decade of clinical experience with the Avalus valve.
