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Edwards Valve Set for July FDA Panel Review

Edwards Lifesciences Corp. of Irvine now has a date with regulators for its highly touted Edwards Sapien heart valve.

The medical device maker said last week that a Food and Drug Administration advisory panel plans to review its application for Sapien on July 20.

The review is for the valve to be considered to treat patients who have severe aortic stenosis, or an abnormal narrowing of the heart’s aortic valve opening.

The FDA generally follows the advice of its panels on drug and medical device reviews.

Edwards has said it could introduce Sapien in the U.S. later this year. The company projects some $40 million in costs related to the launch.

Sapien, which had overseas sales of $72.7 million in the first quarter, is inserted via a catheter, eliminating the need for open heart surgery.

The device and competing products are considered the biggest advancement in heart valves in years.

Sapien’s progress came up during a presentation by Thomas Abate, Edwards’ chief financial officer, at a Goldman Sachs Group Inc. healthcare conference in Rancho Palos Verdes last week.

Abate was asked about how Edwards would manage Sapien’s commercial rollout, including training of doctors.

“We’ve had quite a bit of time to really fine-tune and perfect the training,” Abate said. “We’ve seen that we could bring it to as many as 250-plus centers in Europe and they’re getting very, very successful results.”

Edwards “went very slow in Europe” when it introduced Sapien there in late 2007, Abate said.

“The way we’re teaching today (is) rather than a burst of training, we’re coming in and doing it in multiple doses,” he said. “We’ve learned a lot about making it stick better and making sure that people avoid some of the early pitfalls.”

Game Change

Sapien is expected to be a game-changer for Edwards, which has annual sales of $1.4 billion.

Analysts have estimated the worldwide market opportunity for less-invasive heart valves at more than $2 billion in yearly sales.

Sapien looks like it will see U.S. sales in the fourth quarter, according to Larry Biegelsen, an analyst with Wells Fargo Securities.

“We expect a positive panel recommendation and ultimately FDA approval of Sapien,” Biegelsen said in a research note.

Separately, the device maker said a smaller version of the valve, the Edwards Sapien XT, was successfully implanted in a pair of Chinese patients.

The implants were performed in May at China’s Second Military Medical University under an educational and training program on transcatheter aortic valve implants between Edwards and the university, the device maker said in a statement.

China Plan

Edwards hopes to gain approvals to launch Sapien XT in China as early as 2013, said Huimin Wang, its corporate vice president, Japan, Asia Pacific and Latin America.

Sapien XT was approved for European sale in 2010.

Other topics addressed in Edwards’ Goldman Sachs presentation included its $43 million purchase of Pennsylvania’s Embrella Cardiovascular Inc. in March.

Embrella developed a single-use, disposable deflector that moves blood clots away from the area where doctors insert valves in patients via catheters.

Promising Technology

Edwards said at the time of the buy that Embrella’s device, which has European regulatory approval, could be used during catheter heart valve procedures without blocking blood flow to the brain.

“We grabbed up that technology because we think it’s the most promising … in the market today,” Abate said.

Edwards is “very optimistic” that Embrella will make a difference in transcatheter procedures, he said.

The company’s goal for Embrella “this year is to better understand it, put it in the hands of a few clinicians out there and try to understand what the potential is for it,” Abate said.

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