Medtronic scored FDA approval and a CE mark for its Avalus pericardial aortic surgical valve for the treatment of aortic valve disease. It is the first stented surgical aortic valve that is also MRI-compatible.
While some people are born with aortic valve disease, it can develop as a person ages. Characterized by an aorta that does not work properly, it includes aortic valve stenosis, where scarring or calcium deposits narrow the artery, blocking blood flow, and aortic valve regurgitation, where the valve does not close completely, letting blood flow backward into the left ventricle.
Aortic valve disease may be treated with valve repair or replacement, which can be done surgically or via catheter in a minimally invasive procedure. The Avalus valve includes several updates to improve implantability and outcomes, as well as fulfilling the needs of cardiac surgeons, Medtronic said in a statement. It will launch the device later this year.
"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., epartment head of cardiothoracic surgery at the Leiden University Medical Center in the Netherlands. "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."
The twin approvals are based on subsets of data from the PERIGON pivotal trial, which Klautz is leading as co-primary investigator. The single-arm, nonrandomized prospective study involves more than 1,100 patients at about 40 sites in Europe and North America. Data presented at the American Association of Thoracic Surgery showed that patients who received the Avalus valve had low adverse event rates, high survival and better blood flow after one year. The study will follow the patients for five years.
Medtronic markets a range of surgical valve replacements, including annuloplasty systems for the repair of leaking mitral valves, as well as tissue and mechanical valves. The latest version of its CoreValve transcatheter aortic valve replacement (TAVR) earned FDA approval earlier this year.