Medtronic plc, a global leader in healthcare technology, today announced the launch of the Avalus Ultra™ Bioprosthesis valve in Western Europe during the 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.9,10,11 More specifically, the Avalus Ultra surgical valve has:
- A low valve profile designed to facilitate ease of use at implant.1,2 with industry-leading EOA that may allow for greater blood flow that is supported by the clinical evidence of the Avalus valve5,6
- A polyetheretherketone (PEEK) base frame, which provides a durable foundation to maintain valve circularity3, 4
- A radiopaque coil for clear fluoroscopic visibility for potential TAV-in-SAV procedures7,8
“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. 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.12
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the U.S. Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 Based on internal test report D00998354, Avalus Ultra HFE Design Validation Test Report.
2 Based on internal document D00437207, Avalus Ultra Design Concept.
3 Based on internal test report D00997823, Avalus Ultra Full Valve Stiffness Design Verification Report.
4 Based on internal test report D00998399, Design Characterization Report: External Sewing Ring Diameter, Valve Housing External Diameter, and Inflow Orifice
5, 6 Klautz RJM, Dagenais F, Reardon MJ, Lange Ru¨diger, Moront MG, Labrousse L et al. Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes. Eur J Cardiothorac Surg 2022; doi:10.1093/ejcts/ezac374.
7 Based on internal test report D00998354, Avalus Ultra HFE Design Validation Test Report.
8 Based on internal document D00437207, Avalus Ultra Design Concept.
9 Klautz RJM, Dagenais F, Reardon MJ, Lange R, Moront MG, Labrousse L et al. Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes. Eur J Cardiothorac Surg 2022 Aug 3;62(3)
10 Klautz RJM, Rao V, Reardon MJ, et al. Hemodynamic function of contemporary surgical aortic valves 1 year postimplant. Abstract presented at: 37th Annual Meeting of the European Association for Cardio-Thoracic Surgery; October 4-7, 2023; Vienna, Austria.
11 Sohn SH, Kang Y, Kim JS, et al., A Randomized Trial Comparing One-year Hemodynamics of Two Bovine Pericardial Valves. Thorac Cardiovasc Surg. 2023 Dec 5
12 Sabik JK, et al., 7-year follow-up of >1100 patients who received a contemporary pericardial aortic bioprosthesis. Presented at EACTS. Lisbon, Portugal. October 2024.
Contacts:
Becky Dvorak
Public Relations
+1-612-309-7149
Ryan Weispfenning
Investor Relations
+1-763-505-4626
