Medtronic touts 1-year data on Avalus surgical aortic valve

Medtronic (NYSE:MDT) today reported 1-year results from a clinical trial of its Avalus pericardial aortic surgical valve, touting low rates of adverse valve-related events and high survival numbers.

Data from the study were presented at the European Assn. for Cardio-Thoracic Surgery’s annual meeting in Barcelona this week.

“With more than 25 years of experience in the surgical valve space, we have designed the Avalus valve through close collaboration with expert surgeons. The valve design concepts and contemporary features are designed to help facilitate procedural ease of use while enabling the lifetime management of the patient. We are very pleased to see the initial positive outcomes from this trial and intend to report on the growing body of evidence at future congresses,” heart valve therapies GM Rhonda Robb said in prepared remarks.

The data are from the 1,300-patient Perigon pivotal study, Fridley, Minn.-based Medtronic said, which aimed to investigate surgical aortic valve replacements. Results from a cohort of 270 patients were analyzed at 1 year, with 91% of the patients in the cohort being deemed at low risk for open heart surgery.

All-cause mortality was reported at 3.6%, with cardiac death at 1.1%. Rates of thromboembolism were reported at 2.2%, endocarditis at 1% and paravalvular leaks were 0.5%, Medtronic said.

The rate for all hemorrhages was 3.7%, with major hemorrhages at 2.7%. No thrombosis, hemolysis, severe paravalvular leaks or structural valve deterioration were reported after a year, the company said.

Patients treated with the Avalus valve showed improved hemodynamic performance, with mean aortic gradients improving from 42.3 mmHg to 12.6 mmHg, Medtronic said.

“As surgical aortic valve replacement remains one of the most important treatment options for patients, the 1-year outcomes from the Perigon trial demonstrate how the advanced design elements of Avalus contribute to positive valve performance and clinical outcomes. The value of this large, contemporary dataset is that it allows surgeons to better understand treatment for today’s SAVR patients, as opposed to data from older studies that may not be as representative,” co-primary investigator Dr. Robert Klautz, of Holland’s Leiden University Medical Center, said in a press release.

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