Edwards Lifesciences (NYSE:EW) wasted no time in touting its success in bringing the first catheter-based aortic valve replacement system to the U.S. when the FDA cleared the Sapien TAVI system late last year, but the company has since taken a more patient approach to penetrating the market.
Edwards is spending time inspecting hospital facilities, training doctors and supervising early procedures using the Sapien valve to keep a close eye on the release of the novel therapy.
That means some potential customers and patients may face delays in gaining access to the newly cleared Sapien system, according to a Wall Street Journal report.
The Irvine, Calif.-based device maker plans to attract between 150 and 250 customers for the Sapien system, the first artificial aortic valve replacement system available in the U.S. without open-heart surgery.
At about $30,000 per device, Edwards expects to sell between $150 million and $250 million worth in its first 12 months of U.S. launch, according to company documents. Fiscal 2012 U.S. sales are expected to be between $200 million and $260 million.
Rather than opening sales to all certified hospitals, Edwards is being more selective in penetrating the U.S. market, which may mean delays in availability of the procedure.
Hospitals sites wishing to use Sapien must fit certain guidelines and undergo "disciplined training," which includes didactic sessions, case observation and simulations. Edwards declined to provide specific numbers on how many had undergone the training thus far.
"We developed a philosophy early on that we need to have extraordinary medical results," said CEO Michael Mussallem told the Journal. "When doctors have success, they’re willing to treat other patients. If they were to have procedural failures, it would very much discourage the rollout of the technology."
The news follows recent studies cautioning about the steep “learning curve” for TAVI procedures, with some warning that it may take as many as 30 procedures for physicians to become proficient at the procedure.
"How all this will play out over the next year should concern every center and operator contemplating the addition of TAVI to their list of available therapies," Journal of the American College of Cardiology: Cardiovascular Interventions editor Dr. Peter Block wrote in an editorial accompanying one of the studies. "[I]t may take more than a full year for an operator to become procedure ‘proficient,’ [and] the question of maintenance of proficiency is totally unanswered at present."
Edwards is asking its customers to buy at least 8 valves up-front and each hospital must have appropriate teams of heart surgeons and interventional cardiologists as well as operating rooms with imaging equipment on hand, according to the newspaper.
"We’ve learned a lot about what we think is a successful formula: Deeply experienced people, infrastructure, and commitment," Mussallem said. "We ask people to really demonstrate a level of commitment that they’re going to continue to do the procedure."
The company has also planned 2 rigorous post-approval studies, one of which aims to follow all patients from the Partner studies (initially used to support Sapien’s FDA bid) to assess valve durability and patient quality of life outcomes at 5 years. That data will be reported to the FDA. A 2nd study will follow about 1,100 newly enrolled patients, aiming to watch the procedural learning curve at more than 50 sites, observe safety and effectiveness and watch for complications for reports that will ultimately go to a national registry.
Edwards also has investigational device exemption approval for clinical trials of the Sapien for moderate risk patients, potentially allowing a greater pool of patients to opt for the less-invasive procedure.
Sapien landed FDA clearance in November 2011 for treatments of patients too sick to undergo open-heart surgery. Its nearest competitor in the TAVI market, Medtronic’s (NYSE:MDT) CoreValve TAVI system, is expected to hit the U.S. market in 2014.