Edwards Launches U.S. Trial for Sapien 3 Heart Valve

Edwards Lifesciences Corporation has received Investigational Device Exemption approval from the U.S. Food and Drug Administration to initiate a single-arm, non-randomized clinical trial of the SAPIEN 3 transcatheter aortic heart valve in the treatment of intermediate risk patients with severe symptomatic aortic stenosis.

The company also completed enrollment in its U.S. clinical trial studying the SAPIEN 3 valve in the treatment of high-risk or inoperable patients. The SAPIEN 3 valve is the only transcatheter heart valve available to U.S. patients that can be delivered through a low-profile 14-French expandable sheath (eSheath), Edwards claims. It also has an outer skirt — a cuff of fabric surrounding the bottom of the frame — to provide a seal to address paravalvular leak. The SAPIEN 3 valve can be implanted with the transfemoral approach through an incision in the leg, as well as alternative access approaches.

This next-generation device isn’t available yet, but executives expect a CE mark “in the near future,” according to the study announcement. The target U.S. approval date: by 2016.

Edwards has international approval for Sapien as well as a U.S. monopoly. It is working hard to keep up the momentum, with expectations to win FDA approval for its lower-profile Sapien XT in the first half of 2014.

The new U.S. trial of the SAPIEN 3 valve will enroll up to 1,000 patients with a Society of Thoracic Surgeons score of 4 to 8 percent, which indicates the average predicted risk of operative mortality at 30 days. All enrolled patients can receive a SAPIEN 3 valve.

“The SAPIEN 3 valve is a significant advancement, and we’re excited to make progress toward bringing this sought-after transcatheter therapy to U.S. patients. It represents a big step toward fulfilling the promise of a simpler procedure with fewer complications and faster patient recovery,” said Larry L. Wood, corporate vice president, transcatheter heart valves. “Last year, we completed enrollment in the first U.S. randomized controlled trial involving intermediate risk patients with severe aortic stenosis. This unique dataset of 2,000 patients receiving surgery or transcatheter valve replacement will provide a thorough baseline comparison for this new study of the SAPIEN 3 valve in intermediate risk patients.”

Edwards said in December that it expected Sapien to generate between $700 million and $820 million in revenue in 2014, well below analysts’ estimates. Increased competition plays a large part in that, which makes Sapien 3’s trial success all the more crucial in the months ahead.

Edwards Lifesciences develops heart valves and hemodynamic monitoring technology.