Edwards Lifesciences Corp. is one step closer to introducing its much-touted, less-invasive replacement heart valve despite some concerns raised by regulators.
A Food and Drug Administration panel last week endorsed the Irvine-based device maker’s Edwards Sapien valve for patients with severe aortic valve narrowing who are too sick for surgery.
The valve received a 9-0 favorable vote with one abstention from the FDA’s Circulatory Systems Devices Panel.
Generally, the FDA follows the recommendations of its advisory panels.
The agency will make a final decision on Sapien at a later date.
“This represents another important step on the path to what we hope will lead to FDA approval (of Sapien),” said Edwards Chief Executive Michael Mussallem.
Long Deliberations
Edwards Sapien is a replacement heart valve that is threaded through the arteries via a catheter. Edwards got the technology in 2003, when it spent $125 million for New Jersey startup Percutaneous Valve Technol-ogies Inc.
The panel’s vote to move Sapien along in the FDA approval process came after long deliberations on clinical trial statistics and labeling, according to a Reuters report.
Some panel members were concerned that the valve might be used in patients who were not ideal candidates and by operators and centers lacking sufficient experience, according to Forbes.
The magazine also reported that the committee spent a good deal of time talking about potential stroke risks.
An FDA staff report raised concerns about potential stroke risks, saying that the percentage of patients who received transcatheter valves and suffered a stroke was higher compared to other therapies.
“There was a significant increase in the neurological event risk in the Sapien arm compared to control,” the FDA said in a report.
Abstention
The panel member who abstained on the final vote told Reuters that he had planned to vote favorably but felt that study data had not been presented “coherently” to the panel.
Concerns about potential strokes appear to have been a factor in a 6% drop in Edwards’ shares on the day it re-ported second-quarter results.
The company’s profit edged up 1% from a year ago, to $58.1 million, slightly below Wall Street’s expectations.
Sales grew 18% to $431.2 million.
Sapien has been a strong performer for Edwards—in the second quarter its sales came in at $85.3 million, up 60% from the previous year.
Edwards began selling Sapien in Europe in late 2007. The company could start selling the valve domestically in the fourth quarter.
• THE NEWS:
Key FDA panel voted to approve Edwards Sapien less-invasive heart valve despite concerns about stroke risks
• BACKGROUND:
Valve already sold in Europe, seen as a breakthrough product with potential market of $2 billion annually
• WHAT’S NEXT:
Edwards Sapien on path for final clearance for U.S. sales; analyst trimmed expectations on number of surgical centers likely to adopt use immediately
Doctor Training
Requirements for doctor training, patient selection and patient registry could slow the use of Sapien at surgical centers across the U.S., according to analyst Bruce Jackson of New York-based Morgan Joseph TriArtisan LLC.
“The FDA could require additional physician training, require at least two surgeons to make the assessment as to whether a patient is inoperable and limit the number of centers to 200, which is lower than the 200-400 target mentioned by Edwards at its analyst meeting last December,” Jackson said in a client note.
Jackson also gave an estimate of potential revenue for Sapien, saying that current guidance assumes that Edwards would see U.S. Sapien revenue of $150 million to $200 million in the first 12 months after its approval, based on it being available at 200 to 400 implanting centers.
The projection assumes three to five cases per quarter at an average unit price of $30,000 per procedure, he said.
Analysts have estimated that the worldwide market for less-invasive heart valves ultimately could grow to more than $2 billion annually.
Head Start
Edwards is considered to have a head start on its competitors in the market, including Medtronic Inc., a Minnesota company with Orange County operations.
Medtronic’s CoreValve, which came to the company through its 2009 buy of Irvine-based CoreValve Inc. for $700 million, still is a few years away from being introduced here.
