FDA Approves Boston Scientific’s Lotus Edge Aortic Valve System

Boston Scientific has secured approval from the US Food and Drug Administration (FDA) for its Lotus Edge aortic valve system to treat patients with severe aortic stenosis.

Lotus Edge is a transcatheter aortic valve replacement (TAVR) technology secured approval to treat patients with severe aortic stenosis who are considered at high risk for surgical valve replacement through open heart surgery.

According to the company, aortic valve stenosis is the process of thickening and stiffening in the valve, which may result in an abnormal narrowing of the aortic valve opening and reduction in blood flow.

Boston Scientific interventional cardiology global president and executive vice president Kevin Ballinger said: “Bringing the much-anticipated LOTUS Edge valve system to market allows us to provide patients who aren’t good candidates for traditional surgery a safe and effective treatment alternative to restore proper function to their severely narrowed aortic valve.”

Lotus Edge, which will be delivered through minimally-invasive procedure, is claimed to be the only FDA-approved aortic valve that helps physicians to reposition and completely recapture the valve once it has been fully deployed.

The system is provided with a braided valve frame and an adaptive seal, which minimizes paravalvular regurgitation or leaking (PVL) by conforming to the patient’s native aortic valve.

Lotus Edge’s Depth Guard technology will help reduce left ventricular outflow tract (LVOT) interaction and permanent pacemaker (PPM) rates by minimizing the depth of the valve during deployment.

Lotus Edge is part of the firm’s suite of structural heart product solutions, which includes Sentinel cerebral protection system, Watchman left atrial appendage closure device and Acurate neo aortic valve system available in Europe.

Boston Scientific has begun a controlled launch of the aortic valve system in Europe in March, and intends to commence a controlled launch in the US in the coming weeks.

Boston Scientific global chief medical officer and executive vice president professor Ian Meredith said: “We are thrilled to offer physicians in the U.S. and Europe the clinical benefits of the LOTUS Edge valve system for the treatment of their high-risk patients with severe aortic stenosis.” – Compelo