Medtronic wins FDA nod, CE Mark for Avalus aortic valve

Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union and FDA approval in the US for its Avalus pericardial aortic surgical valve designed to treat aortic valve disease.

The Avalus is the Fridley, Minn.-based company’s next-gen pericardial surgical aortic valve, and features a supra-annular design to improve hemodynamic performance and limit central regurgitation.

The valve also features interior-mounted leaflet and frame design for improved durability and a low-profile design with a streamlined valve holder and single, one-cut release for easier implantations, Medtronic said.

“Medtronic is committed to advancing its surgical portfolio to offer cardiac surgeons a contemporary option to help meet the individual needs of this patient population. By continuing to collaborate with leading cardiac surgeons around the world, we look forward to bringing heart valve replacement solutions like the Avalus valve to assist in expanding access and improving outcomes for clinical and patient communities,” heart valve therapies biz GM Rhonda Robb said in a press release.

Regulatory clearances came backed by subsets of data from the pivotal Perigon trial of the valve, which examined the use of surgical aortic valve replacements. Results from the trial indicated low rates of adverse valve-related events, high survival and improve hemodynamic performance at 1-year.

Patients in the Perigon trial will be followed up to 5 years, Medtronic said.

“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,” Perigon trial co-primary investigator Dr. Robert Klautz of The Netherlands’ Leiden University Medical Center said in a prepared statement.

Medtronic said it plans to make the Avalus valve available later this year.

The clearance of the Avalus valve comes only days after Medtronic said it won CE Mark approval for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery

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