Boston Scientific’s Lotus Edge valve system receives CE Mark

Boston Scientific has announced that its new Lotus Edge valve system has been granted European CE Mark approval.

The next-generation transcatheter aortic valve implantation technology is designed for aortic valve replacement in patients with severe aortic stenosis who are considered at high risk for surgical valve replacement.

Avoiding the need for open heart surgery, the system allows the replacement valve to be delivered via transcatheter percutaneous delivery, a minimally invasive procedure involving a small incision to gain access to a blood vessel.

Lotus Edge improves upon the previous Lotus valve system by incorporating a more flexible, low-profile catheter designed to improve ease of use, while the Depth Guard design element helps to reduce the need for a permanent pacemaker.

It will initially be available only to selected centres across Europe, with commercial site expansion to gather pace as more physicians and centres become fully trained in its use.

Kevin Ballinger, president of interventional cardiology at Boston Scientific, said: "The Lotus Edge valve system is designed to give physicians increased control during implantation, which can help provide a more precise, predictable procedure to ensure the best patient outcomes."

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