European Regulators Approve First Transcatheter MV Replacement Device
Approved for patients at prohibitive risk of surgery, Tendyne is the first available transcatheter mitral valve replacement for MR.
European regulators have approved the first transcatheter mitral valve replacement system (Tendyne; Abbott) for use in patients with significant mitral regurgitation (MR) who are ineligible for surgery or transcatheter mitral valve repair, according to an announcement from the manufacturer today.
The CE Mark is based on the results of the Tendyne Global Feasibility Study which was first presented at TCT in 2017. In that trial of 100 patients at high/prohibitive risk for surgery, transcatheter mitral valve replacement with Tendyne eliminated MR in more than 98% of patients who received the device. For the 72% of patients who survived to 1 year, there was a significant improvement in symptoms, with more than 86% in NYHA class I/II heart failure. There were also significant improvements in quality of life.
The trileaflet device, which is delivered transapically and is repositionable and retrievable, will be available in multiple sizes.
Tendyne is not available in the United States, but Abbott has launched the 1,000-patient SUMMIT trial investigating the safety and feasibility of the device in patients with symptomatic, moderate-to-severe MR. The study includes a randomized cohort—which includes a comparison of Tendyne against percutaneous mitral valve repair in selected patients with MitraClip (Abbott) indications—and a nonrandomized cohort where patients are treated solely with Tendyne. Results of the study are not expected until 2022.