Device first used at OHI receives FDA approval

A device used for the first time in the world by cardiologists at Oklahoma Heart Institute, part of Hillcrest Medical Center, has now received authorization by the U.S. Food and Drug Administration (FDA).

The Edwards PASCAL Precision system is used in the treatment of severe degenerative mitral regurgitation (DMR) in patients who are high-risk for surgery. The device, with its independent grasping, atraumatic clasp and closure, and ability to elongate, enables safe and effective treatment for patients with DMR, according to Edwards Lifesciences Corporation.

The FDA approval was based on results from the CLASP IID/IIF Pivotal Trial in 2021. Results of the CLASP IID study were presented and published at the TCT conference in Boston in September 2022.

“Oklahoma Heart Institute was the first center in the world to use the Edwards PASCAL Precision system,” said Dr. Kamran Muhammad, director of the structural heart disease program at Oklahoma Heart Institute. “OHI was also the only center in Tulsa participating in the CLASP IID study, making us the only Tulsa hospital with experience using this newly-approved device.”

To date, the Oklahoma Heart Institute structural heart program remains the premier program of its kind in the region, with the most experience and superior outcomes.

KOTV recently spoke with Dr. Muhammad about this device. See his interview here: