- Edwards Lifesciences said it has received CE Mark approval in Europe for its latest transcatheter aortic valve replacement (TAVR), called the Sapien 3 Ultra. The device is approved for patients with severe aortic stenosis, a condition that restricts blood flow and forces the heart to work harder.
- The design includes a new valve delivery system and sheath to help the surgeon place the device in the heart more efficiently.
- The company will not immediately launch the product in Germany due to a preliminary injunction granted to Boston Scientific. Elsewhere in Europe, Edwards will introduce the system in a controlled rollout that includes training for doctors on the procedure.
TAVR procedures are a fast-growing medtech market due to their emergence as an alternative to open-heart surgery for many patients who need a new aortic heart valve. As such, the valves are a hotly contested market among the companies that make them: Edwards Lifesciences, Medtronic and newcomer Boston Scientific.
Edwards estimates global TAVR procedures continue to grow in the mid-teens, but the valve pioneer has admitted to conceding some market share outside of the United States to competitors.
The company's newest TAVR device will strengthen Edwards' position just as Boston Scientific prepares to reintroduce its Lotus transcatheter valve in Europe in the first quarter of 2019. Boston has made design and manufacturing process changes to its Lotus device to address malfunctions that prompted the company to pull the product from the European market in February 2017.
Last month, a German court ruled that Edwards' Sapien 3 Ultra valve infringed a patent held by Boston Scientific unit Symetis on the fabric used for the valve seal. The court granted Boston a preliminary injunction. Boston has a second heart valve that it sells in Europe called Acurate, which it gained through its 2017 acquisition of Symetis.
"Edwards is disappointed in Boston Scientific's tactic to limit access of this new therapy. The German court will hold a full hearing on the merits of the dispute in mid-2019, and Edwards continues to believe that it will ultimately prevail in this matter," Irvine, California-based Edwards said in a press release.
Other Edwards' transcatheter aortic valves, Sapien 3 and Centera, remain available in Europe. Centera is a new offering that received Europe's CE mark in February. In the United States, Edwards expects to receive FDA approval for the Sapien 3 Ultra sometime near the end of this year.
Edwards said the Sapien 3 Ultra system includes an expandable sheath for delivering the device to the heart that removes the need for valve alignment during the procedure. In addition, the outer skirt of the valve is designed to prevent a complication called paravalvular leak characterized by a gap between the replacement valve and the patient's native tissue.
"The Edwards Sapien 3 Ultra system incorporates features designed to help simplify and improve the efficiency of the procedure," said John Webb, director of interventional cardiology and cardiac catheterization laboratories at St. Paul's Hospital in Vancouver. "This design innovation represents a meaningful advancement over previous generations of this technology."