Surgeons at Beaumont Hospital in Royal Oak have implanted the world’s first Foldax Tria flexible polymer heart valve into a patient. The new valve has the potential to address durability and blood clotting issues associated with traditional replacement heart valves.
Dr. Marc Sakwa performed the surgery on July 30 as part of a clinical trial for the treatment of aortic valve disease that still needs additional federal approvals and testing before it will be available to patients beyond the trial.
“Our Tria valves are a combination of innovative material, state of the art biomechanical design, and a game-changing manufacturing process,” says Ken Charhut, executive chairman of Foldax, a company based in Utah. “The work we are doing has the potential to revolutionize the heart valve industry and save many lives.”
Dr. Sakwa and Royal Oak Beaumont’s cardiac catheterization medical director, Dr. George Hanzel are the primary investigators for the FDA early feasibility study.
The recipient of the experimental valve is Bob Murley, 68, a semi-retired IT developer living in Chesterfield Township. He was first diagnosed with aortic valve disease about 10 years ago.
“I used to be able to run for an hour without any problems,” says Murley. “I was even running half-marathons. When just going up a few stairs made me start huffing and puffing, I knew something was wrong. I suspected the symptoms were related to my heart issue because of all the conversations I had with Dr. (Charles) Heth over the years.”
The team at Beaumont decided Murley was a strong candidate for the new polymer valve due to his being in excellent physical condition. Sakwa became his cardiac surgeon.
“Mr. Murley was in excellent physical shape and had a great attitude and support system,” Sakwa says. “He was an ideal candidate for a minimally invasive approach.”
Patients interested in potentially qualifying for future phase of the clinical trial are welcome to contact Diedre Brunk, Beaumont’s manager of cardiology clinical research at 248-898-5580.