Medtronic also received FDA approval for revised TAVR labeling that marks a critical moment for treating patients with bicuspid severe aortic stenosis.
Indication is to the transcatheter aortic valve replacement (TAVR) market as location is to the real estate business.
Although TAVR already represents a $3 billion market globally, the leading TAVR companies say the currently approved indications barely scratche the surface in terms of the true growth potential of the space. This week, just ahead of the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Diego, Medtronic announced that FDA has given the go-ahead for 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 Dublin, Ireland-based company also received FDA approval for revised commercial labeling for the CoreValve Evolut TAVR system that removed a precaution for the treatment of bicuspid severe aortic stenosis patients deemed at intermediate or greater risk for surgical aortic valve replacement (SAVR).Bicuspid valve patients are born with two aortic valve leaflets instead of the more common three leaflets (tricuspid). Medtronic noted that 1 in 5 patients undergoing SAVR is a bicuspid valve patient.
“Real-world data suggests that TAVR with the self-expanding Evolut can be a suitable treatment option for many patients with bicuspid aortic valve disease,” said Jeffrey Popma, MD, director of interventional cardiology at the Beth Israel Deaconess Medical Center in Boston, MA. “In fact, data from the TVT Registry has shown near-parity in certain outcomes between bicuspid and tricuspid patients using the Evolut self-expanding platform.”
Medtronic is studying bicuspid patients within a separate single-arm study of the low-risk TAVR trial. In the United States, treatment with bicuspid aortic valves in patients who are at low risk of surgical mortality is investigational use only.
“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,” said Pieter Kappetein, MD, vice president of medical affairs for Medtronic's structural heart business. “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.”