Medtronic has received approval from the US Food and Drug Administration (FDA) for revised commercial labeling for the CoreValve Evolut TAVR system.
The US regulator approved an investigational device exemption (IDE) to start a single-arm study to evaluate the CoreValve Evolut TAVR system in patients with bicuspid aortic valves who are at low risk of surgical mortality.
The revised labeling of CoreValve Evolut system removes a precaution for the treatment of bicuspid severe aortic stenosis patients deemed at intermediate or greater risk for surgical aortic valve replacement.
It is estimated that one in five patients undergoing surgical aortic valve replacement (SAVR) are affected by bicuspid valve. Patients with bicuspid valve are born with two aortic valve leaflets instead of the more common three leaflets (tricuspid).
While the revised labeling approval is applicable to patients deemed at Intermediate Risk or greater for SAVR, Medtronic is conducting study on bicuspid patients within a separate single-arm study of the Low Risk TAVR Trial.
In the US, treatment for bicuspid aortic valves in patients who are at low risk of surgical mortality is still in the investigational stage only.
Medtronic Cardiac and Vascular Group Structural Heart business vice president Pieter Kappetein said: “As a leader in heart valve solutions, this label revision enables us to provide proactive training and education on procedural TAVR sizing and placement in this patient population.
“The bicuspid study, in addition to new studies on TAVR efficiencies and leaflet mobility, will provide important insights as we look to further refine TAVR therapy.”
Medtronic claims itself as a leading innovator of heart valve therapies, including the first transcatheter pulmonic valve, the first self-expanding and recapturable transcatheter aortic valve, and the first transcatheter mitral valve replacement technology to be studied in a global pivotal trial.
The company introduced the self-expanding CoreValve System in 2014, and the Evolut R system in 2015. The third-generation Evolut PRO TAVR system was approved in the US and Europe for extreme-, high-, and intermediate-risk patients in 2017.
In collaboration with clinicians, researchers and scientists worldwide, Medtronic offers a range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.