Boston Scientific Receives CE Mark For LOTUS Edge Valve System

Boston Scientific has received CE Mark for the LOTUS Edge™ Valve System, the company’s next generation transcatheter aortic valve implantation (TAVI) technology. The LOTUS Edge valve system is indicated for aortic valve replacement in patients with severe aortic stenosis who are considered at high risk for surgical valve replacement. Instead of open heart surgery, the replacement valve is delivered via transcatheter percutaneous delivery, a minimally invasive procedure involving a small incision to gain access to a blood vessel.

In comparison to the Lotus™ Valve System, this next iteration incorporates a more flexible, lower profile catheter designed to improve ease of use and accommodate tortuous anatomy. Another differentiating feature of the LOTUS Edge valve system is the inclusion of Depth Guard™, a design element intended to reduce the need for a permanent pacemaker (PPM).
A press release is available from Boston Scientific website.