Boston Scientific gets FDA approval for LOTUS Edge system

24 April 2019 (Last Updated April 24th, 2019 11:57)

Boston Scientific has received the US Food and Drug Administration approval for the use of LOTUS Edge Aortic Valve System to treat severe aortic stenosis.

Boston Scientific gets FDA approval for LOTUS Edge system
The LOTUS Edge Aortic Valve System. Credit: Boston Scientific Corporation.

Boston Scientific has received the US Food and Drug Administration (FDA) approval for the use of LOTUS Edge Aortic Valve System to treat severe aortic stenosis.

LOTUS is a transcatheter aortic valve replacement (TAVR) device intended for patients who are considered to be at high risk of needing surgical valve replacement through open heart surgery.

With LOTUS Edge, physicians will able to reposition and also completely recapture the valve system after it has been fully deployed.

Boston Scientific Interventional Cardiology executive vice-president and global 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.”

The LOTUS Edge system comes with a braided nitinol valve frame and an adaptive seal to reduce paravalvular regurgitation or leaking (PVL) by conforming to the patient’s natural aortic valve.

“This system provides physicians a high level of control over the delivery and deployment of the device and offers surgical-like PVL results to help ensure the best patient outcomes.”

It also features Depth Guard technology that helps in reducing the depth of the valve during deployment in order to mitigate left ventricular outflow tract (LVOT) interaction and permanent pacemaker (PPM) rates.

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

“This system provides physicians a high level of control over the delivery and deployment of the device and offers surgical-like PVL results to help ensure the best patient outcomes.”

The new device expands the company’s Structural Heart product range, which also comprises SENTINEL Cerebral Protection System, WATCHMAN Left Atrial Appendage Closure Device and ACURATE neo Aortic Valve System.

Boston Scientific initiated a controlled roll-out of the LOTUS Edge system in Europe in March this year and intends to bring the device to the US market in the coming weeks.