LOTUS Edge Valve System receives CE Mark for aortic valve replacement,- Boston Scientific.

Boston Scientific Corporation 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).

The LOTUS Edge valve system will be available to select centers in Europe, with commercial site expansion accelerating as physicians and centers become fully trained. The Lotus Valve System is an investigational device in the United States and Japan and is not available for sale in those countries.

Comment: Leveraging the original Lotus platform, the LOTUS Edge valve system integrates the Adaptive Seal technology which minimizes paravalvular regurgitation (leaking) or PVL, as demonstrated in the 1,000 patient RESPOND Post-Market Registry. This study found that 91.9% of patients had core-lab adjudicated trace or no PVL pre-discharge, and 7.7% had mild PVL. No patients had severe PVL and only 0.3% of patients had moderate PVL. LOTUS Edge continues to be the only TAVI device that offers controlled mechanical expansion, which allows the valve to be fully deployed and assessed and then repositioned or fully retrieved by the physician, if needed.