One of Edwards Lifesciences Corp.’s major projects,developing a heart valve that doesn’t require major surgery,is moving along and gaining notice among analysts.
Irvine-based Edwards recently started a key trial for a new type of valve inserted via a catheter, with an eye toward gaining Food and Drug Administration approval around 2010.
European approval and sales could come by the end of this year.
“We completed a feasibility trial and what we saw in that was very good results,” said Larry Wood, corporate vice president of transcatheter valve replacement.
That led to a larger, pivotal trial for the valve, he said, which is set to determine whether regulators sign off on the product.
The trial, which is in the enrollment phase, is set to have 600 patients. Some will be candidates for traditional open-heart surgery. Others will be drawn from those too sick to have major surgery.
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Edwards’ valve: acquired in $125 million deal in 2004 |
Edwards expects to take 18 months to enroll patients and plans to monitor them for a year after the valves are implanted, Wood said.
Getting the less-invasive valve approved in Europe takes less time because regulators there just look for basic proof of safety and performance.
In the U.S., new devices are measured against existing treatments, Wood said.
The valve is inserted through the ribs or via an artery in the groin area.
Some analysts are optimistic about the valves, which saw some early setbacks in feasibility studies.
“We believe many interventional cardiologists see transcatheter valves as the next major growth opportunity following drug-eluting stents,” wrote Larry Biegelsen of Wachovia Securities in a report.
The global market for the less-invasive valves could grow from $43 million next year to more than $1.1 billion by 2015, Biegelsen said.
Edwards could see less-invasive valve sales of $21 million next year, according to Biegelsen. That could grow to more than $540 million by 2014, he said.
The company could gain half the global market for less invasive valves because of its early lead and its existing sales force, Biegelsen said.
“Sales from transcatheter valves and other marketed products should offset slowing growth in Edwards’ core surgical heart valve business, Biegelsen said.
Valves implanted during major surgery make up half of Edwards’ $1 billion in yearly sales. The company leads the market in valves but is seeing pressure from rivals, according to Biegelsen.
Competitors include Medtronic Inc. and St. Jude Medical Inc., both of the Minneapolis area.
Less-invasive valves stand to broaden the market, according to Timothy Lee of Caris & Co.’s San Francisco office.
Only about half of people who have severe aortic stenosis, a narrowing of the valve that restricts blood flow, receive replacement valves. Other conditions that preclude open-heart surgery prevent the other half from doing so.
“Thus, a less invasive procedure would greatly expand the number of patients treatable with valve replacement surgery,” Lee said.
That’s part of Edwards’ plan, according to Wood.
“You drive this new technology into what currently is an untreated patient population,” he said. “Do we see that as being a great growth driver for Edwards? Yeah, we see that as a great future growth driver.”
Edwards got into the less-invasive valve market in 2004, when it spent $125 million to buy Percutaneous Valve Technologies Inc., a Fort Lee, N.J.-based startup.
The company moved ahead with developing the valve, including starting a feasibility trial that was halted in 2005 after complications, including deaths.
Edwards worked with regulators, developed an easier insertion procedure and restarted the feasibility trial with 55 patients. Results led to the current trial, which began three months ago.
