Edwards Lifesciences Corp. (NYSE:EW) is confident that its flagship Sapien transcatheter heart valve device will have a quicker uptake in the U.S. than it did in Europe.
Speaking at an investors conference in Boston, Edwards’ vice president of investor relations David Erickson said the company has several advantages in the U.S. market that it didn’t have when it launched the Sapien device in Europe four years ago.
Aside from the benefit of already rolling out the product in a different market, Erickson said, EW has more centers involved in the Partner clinical trial in the U.S. than it did in Europe. That will provide the company with its first set of customers, he noted.
“We have 20-some sites that are part of the Partner study,” Erickson said. “So we’re starting out with more sites and more clinicians than we did in Europe.”
And Edwards will have more clinical specialists and proctors in place than it did in Europe, to boot. The company is currently building a three-pronged product roll-out that will include sales reps, clinical specialists and proctors, Erickson added. Edwards will put more of an emphasis on the clinical specialists and proctors than sales reps, as it will have a serious head start on its competition on the sales front, Erickson said.
Edwards is set to appear before the FDA’s circulatory system devices advisory panel in July for a review of the company’s pre-market approval application for the Sapien system. If it gets a green light from the panel, it should gain approval from the watchdog agency for commercial sale in the U.S., possibly by the end of the summer (the FDA is not bound by its advisory panels’ recommendations, but usually follows their guidance).
The company is confident it made a strong clinical case with the results of its Partner cohort B clinical trial, Erickson said.
“The outcomes are in our favor and we expect that there’s going to be little in terms of debate in terms of that,” he said.
Edwards officials have said they believe a green light from the FDA for Sapien could bring in $20 million to $25 million in U.S. sales. The company has been riding a wave of positives for the device, which performed well in an eagerly awaited study earlier this year.
Sapien sales in the EU helped drive solid results for Edwards’ transcatheter heart valves unit during the first quarter. The division posted sales of $72.7 million, up 85.7 percent over Q1 2010. CE Mark approval for a larger size of the Sapien device helped add $2 million to $3 million to the tally.
Edwards has already raised its outlook on the rest of the year, boosting its 2011 sales forecast by $70 million, to $1.66 billion to $1.74 billion, and increasing its diluted EPS prediction to $2.01 to $2.07, chairman and CEO Michael Mussallem said.
The FDA panel date means the company is still on track to have a healthy head start on rival Medtronic Inc. (NYSE:MDT) and its CoreValve System in the robust replacement heart valve market. The companies have duked it out in court and the EU market for more than four years. That may be peanuts compared to the U.S. market, however, at least according to some estimates. About 100,000 U.S. patients — roughly a third of the global market mdash; are candidates for the therapy, which involves replacing the diseased aortic valve with an implant inserted via catheter, rather than with open heart surgery.