Israeli heart valve implanted in first US patients

(JNS) — Trisol Medical Ltd., an Israeli medical device company, has successfully implanted its Transcatheter Tricuspid Valve in two patients in the United States.

The procedure involved the replacement of the tricuspid valve through a minimally invasive approach, avoiding the need for cardiopulmonary bypass. Both patients were suffering from symptomatic tricuspid regurgitation, a disorder in which the heart’s tricuspid valve does not close tightly enough, causing blood to flow backward into the right upper heart chamber every time the right lower heart chamber contracts. Left untreated, the disorder may lead to irregular heart rhythm or heart failure.

Both procedures were part of a U.S. Food and Drug Administration-approved Early Feasibility Study.

The first procedure was carried out at the Piedmont Heart Institute in Atlanta on an 84-year-old woman. Doctors were able to insert the replacement valve through the patient’s jugular vein. Following the procedure, doctors saw a dramatic improvement in her condition and she was discharged after two days.

Piedmont doctors Pradeep Yadav, James Stewart and Vinod Thourani said the procedure “marks a major milestone in the management of TR. We were able to abolish the patient’s valvular heart disease via a minimally invasive procedure without the need for cardiopulmonary bypass. The patient was mobilizing within hours of the procedure and her recovery was streamlined and expeditious.”

The second patient was a 77-year-old woman with a more severe case, who underwent the procedure at the University of Virginia Health System in Charlottesville. Her tricuspid regurgitation level was lowered from “severe” to “trace,” and she too was discharged after two days.

Dr. Scott Lim, who conducted the procedure, said, “The patient had a gratifying result with essentially elimination of her tricuspid regurgitation, and rapid recovery, along with significant and rapid improvement in her symptoms. We look forward to further investigation of the Trisol valve.”

The patented valve comprises a single leaflet, affixed by two joints enabling it to function as a bi-leaflet valve.

“There is a huge unmet need for a transcatheter solution to treat severe TR. Trisol’s promising initial clinical data instills confidence that Trisol can play a major role in this domain,” said Trisol chairman Dr. Shimon Eckhouse.

To date, the valve has been implanted in 10 human subjects, five of whom were part of an Israeli pilot study.

Based in Yokneam, near Haifa, Trisol was founded in 2016.