Edwards Sapien 3 wins expanded indication in Europe

human heart

Edwards Lifesciences scored a CE mark to expand the indication of its Sapien 3 TAVR to cover aortic stenosis patients who are at intermediate risk for open-heart surgery.

The new CE mark builds on the device’s original CE mark, received in January 2014, which approved the Sapien 3 for patients with severe, symptomatic aortic stenosis who were at high risk for open-heart surgery. It follows the FDA decision last month to expand the device’s indication to include intermediate-risk patients.

"This expanded intermediate-risk indication allows for the treatment of even more patients whose only previous option was an open-heart surgical procedure," said Prof. Helge Möllmann, director of the Clinic for Internal Medicine (Cardiology) at St. Johannes Hospital, Dortmund, Germany, in a statement.

Decision Resources Group estimated that the U.S. TAVR market had sales of $950 million in 2015, and that Edwards’ Sapien 3 had 70% of the market cornered. At the time, Sean Messenger, principal analyst at DRG, told FierceMedicalDevices that he expected intermediate-risk patients to contribute $400 million in annual U.S. TAVR revenues by 2020, assuming Medtronic receives intermediate-risk approval in 2017.

But it hasn’t all been smooth sailing for Edwards: last year, competitor Boston Scientific filed an intellectual property lawsuit in Europe against the devicemaker, alleging that the Sapien 3 infringes its patents related to adaptive sealing technology. And in April, Boston Scientific filed patent infringement suits in the U.S. District Courts in the District of Delaware and the Central District of California.