Irvine-based Edwards Lifesciences Corp. is wasting no time getting its recently approved heart valve on the market here.
Edwards Sapien is a less-invasive device that’s widely considered one of the biggest advances in replacement heart valves in years.
The device received the Food and Drug Administration’s approval for U.S. sales on Nov. 2. It was available the next day to hospitals that had participated in its clinical trials, according to Sarah Huoh, a company spokesperson.
Sapien costs about $30,000.
Edwards said it expects $150 million to $250 million in domestic Sapien sales in its first 12 months. The mid-range of that estimate would bring an increase of about 12% on the company’s current annual sales of about $1.5 billion.
Hospitals that participated in clinical trials are the first sales prospects because they have personnel trained in the use of the new device.
Edwards also has developed a training program to educate more clinical teams on the use of new device. Those doctors “will undergo comprehensive trainings, which include case studies, lectures and hands-on simulator experience,” Edwards Chief Executive Mike Mussallem said during the company’s third-quarter earnings report last month.
Sapien, which is inserted via catheter, treats severe symptomatic aortic stenosis, or a narrowing of the arteries. Figures provided by Edwards indicated that about 300,000 people in the U.S. have the disease.
Edwards is considered the leader in less-invasive heart valves, and will now have a “monopoly position” in the U.S. until Minneapolis-based competitor Medtronic Inc. can bring its CoreValve to market, Lawrence Neibor, an analyst with Milwaukee investment bank Robert W. Baird & Co., said in a note.
Sapien has been on the market since 2007 in Europe. It accounted for $82.7 million in sales in the third quarter, a 69% increase from the year-ago period.
Even though Edwards has received approval for Sapien, there are still some questions remaining on the ultimate market size for the device, as well as whether Medicare and Medicaid will provide reimbursement. Severe aortic stenosis is often found in elderly people.
About six weeks ago, Medicare and Medicaid started the process of deciding whether they would pay for Edwards Sapien. A decision is expected next June.
