Boston Scientific is Granted CE Mark For LOTUS Edge Valve System

Boston Scientific has received CE Mark for its aortic valve system. The Lotus Edge valve system is designed for aortic valve replacement in patients with severe aortic stenosis who are at high risk for surgical valve replacement.

In this next generation of development for the Lotus Valve System, its additional feature includes the Adaptive Sea technology, which minimizes leaking.

Rather than open heart surgery, the replacement valve is put in via transcatheter percutaneous delivery, which is a small incision, and then inserted into the blood vessel. According the clinical study, 91.9 percent of patients had no leaking pre-discharge, and 7.7 percent had mild leaking. No patients had severe leaking and only 0.3 percent of patients had moderate valve leakage.

The Lotus Valve System is currently not available in the United States or Japan. — Cynthia Jessup