Boston Sci wins CE mark for next-gen TAVR

Boston Scientific scored a CE mark for its next-generation transcatheter aortic valve implantation tech. The system is indicated for patients with severe aortic stenosis who are at high risk for surgical valve replacement.

The Lotus Edge Valve System is the company’s follow-up to its Lotus Valve System, which received a CE mark in 2013. Instead of being implanted through open-heart surgery, the Lotus systems allow the replacement valve to be delivered minimally invasively via catheter.

The Lotus Edge has a lower profile and more flexible delivery catheter compared with its predecessor, the company said in a statement. These updates make it easier to use and to navigate twisted blood vessels. The new device also includes a Depth Guard, which is designed to lower the need for a permanent pacemaker, according to the statement.


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

Lotus Edge is the only TAVI/TAVR device that allows for the repositioning of the valve after it has been deployed and assessed, thanks to its controlled mechanical expansion, Boston Scientific said in the statement.

"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,” said Kevin Ballinger, president of Boston Scientific’s interventional cardiology unit, in the statement.

Suggested Articles

Kintai Therapeutics' anti-obesity candidate KTX-0200 showed sustained weight loss and improved glucose control and liver health in rodents.

The respiratory care company Vyaire Medical has brought on a new CEO, Gaurav Agarwal, following a year of new product launches.

Akcea's triglyceride-fighter beat placebo at lowering blood triglyceride levels in patients who have, or are at risk of, heart disease.