Irvine heart valve maker Edwards Lifesciences Corp. has entered a critical phase in the development of a product it sees playing a key role in future heart surgeries.
A team of Michigan cardiac surgeons Tuesday said they inserted a new Edwards valve into the first American patient as part of a clinical trial.
The valve, inserted via a catheter rather than open-heart surgery, came from Edwards’ 2004 buy of Percutaneous Valve Technologies Inc. for $125 million.
Edwards was given the OK to launch the Cribier-Edwards trial earlier this year after wrestling with regulators over the trial’s design, and enduring some criticism about the valve’s efficacy.
Surgeons at William Beaumont Hospital in Royal Oak, Mich., said they inserted a Cribier-Edwards replacement aortic heart valve into a 76-year-old man. They used a cardiac catheter instead of opening his chest and stopping his heart, as in traditional open-heart surgery for valve implants.
Dr. William O’Neill, the trial’s principal investigator, said in a release the procedure “may offer hope to seriously ill, high-risk patients who are not candidates for traditional open-heart surgery.”
The Percutaneious deal marked Edwards entry into the market for less-invasive valves. Edwards is the leading maker of valves implanted during open-heart surgery with about a third of the market.
Before the Percutaneous buy, one analyst predicted that less-invasive heart valves stood to take business away from Edward’s mainstay line of traditional heart valves.
Edwards has said that it hopes to have complete U.S. approval for the Cribier-Edwards valve by 2007.
Other companies developing less-invasive valves include France’s CoreValve SA, 3F Therapeutics Inc. in Lake Forest and Minneapolis-based Medtronic Inc., which has a heart valve plant in Santa Ana.
