A medical device developed by Tewksbury’s Mitralign Inc. was used this week in what doctors are calling a groundbreaking heart-valve repair procedure.
The three-hour operation was performed by two doctors at New York-Presbyterian/Columbia University Medical Center.
They threaded a catheter through the neck of a 67-year-old woman to insert a pair of fabric anchors called pledgets in the patient’s tricuspid valve and cinche them together in a minimally invasive procedure not previously used for that valve.
“This is the first transcatheter tricuspid valve repair in the United States,” said Dr. Rebecca Hahn, director of interventional cardiology at the New York hospital and principal investigator for an early-stage clinical study of Mitralign’s device. She said a similar procedure had been done in Hamburg, earlier in the fall.
An estimated 1.4 million Americans have leaks in the tricuspid valves on the right side of their hearts, which can lead to heart failure.
While doctors already have the tools to perform transcatheter procedures for mitral and aortic valves on the easier-to-reach left side of the heart, the only way to repair tricuspid valve leaks currently is through risky open-heart surgery.
“This side of the heart has been long neglected,” Hahn said. “This is a tremendously underserved population. There’s no great solutions for these patients right now.”
Hahn performed the operation on the woman, who was not identified, along with Dr. Susheel Kodali, director of the hospital’s structural heart and valve program.
Mitralign, an 11-year-old medical device company with nearly 50 employees, is seeking approval in Europe for a similar product that repairs the mitral valve.
But it is focusing on the tricuspid valve in the United States where there are existing products that do transcatheter repairs on mitral valves.
“There’s no other option for patients in the United States,” said Rick Geoffrion, chief executive of Mitralign. “It’s early, but we believe we have the lead. And we intend to hold it.”
Geoffrion, a chemical engineer who was born in Boston and raised in New Jersey, cofounded Mitralign at Accelerated Technologies Inc., a medical device incubator he formerly ran. It was spun out in 2004 and operated in Salem, N.H., before moving to Tewksbury in 2006.
Mitralign is backed by a consortium of venture capital firms, including Forbion Capital Partners of the Netherlands, Saints Capital of San Francisco, and Oxford Bioscience Partners of Boston. Other investors include Metronic PLC of Ireland and Abiomed Inc. of Danvers.
Geoffrion would not predict when the company’s Trialign device might be submitted for FDA approval, but he said the market is expected to be substantial. Medtronic and Edwards Lifesciences Corp. in Irvine, Calif., already market approved transcatheter repair systems for aortic valves, a market estimated at more than $3 billion a year in combined annual sales.Robert Weisman can be reached at firstname.lastname@example.org. Follow him on Twitter @GlobeRobW.