Medtronic Expands Cardiac Surgery Device Portfolio with FDA and CE Mark Approvals: Avalus Surgical Aortic Valve, CoreValve Evolut PRO Transcatheter Valve

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Medtronic plc recently announced CE (Conformité Européenne) mark and U.S. Food and Drug Administration (FDA) approval of its new Avalus(TM) pericardial aortic surgical valve for the treatment of aortic valve disease. The Avalus valve leverages proven surgical bioprosthetic valve concepts with added features designed to enhance clinical performance, helping to address the contemporary needs of cardiac surgeons, as well as patients who are candidates for aortic valve replacement. 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), the Avalus valve is designed for excellent implantability, an important factor during complex cases.

“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,” said Robert Klautz, M.D., cardiac surgeon and department head of cardiothoracic surgery at the Leiden University Medical Center in The Netherlands. Prof. Klautz is also the co-primary investigator of the PERIGON trial, evaluating the safety and efficacy of the Avalus valve. “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.”

Medtronic also recently announced CE mark and European launch of the CoreValve(TM)Evolut(TM) PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at intermediate, high or extreme risk for open heart surgery. Clinical data for the Evolut PRO valve was recently unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Session, and showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics.

The Evolut PRO device features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve.

“The Evolut PRO valve has shown impressive clinical outcomes, with low paravalvular leak and pacemaker rates,” said Nicolas M. Van Mieghem, MD, director of interventional cardiology at Erasmus Medical Center in Rotterdam, The Netherlands. “With its ease-of-use and deliverability, the Evolut PRO valve will bring TAVI practice to a higher level, and I look forward to seeing it utilized in patients across Europe.”

For Further Information

This report covers the following market segments: tissue heart valves, mechanical heart valves, annuloplasty repair, transcatheter mitral valve repair, transcatheter heart valve implantation, on-pump coronary artery bypass, off-pump coronary artery bypass, endoscopic vessel harvesting, anastomosis assist, cardiac ablation, transmyocardial revascularization, ventricular assist, intra-aortic balloon pumps, artifical hearts, patent foramen ovale, and atrial and ventricular septal devices. Recent reports on the markets for cardiac surgery and heart valve devices cover the U.S. and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.

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