A device used by cardiologists for the first time in the world at Hillcrest Medical Center’s Oklahoma Heart Institute has received Food and Drug Administration clearance.
“Our goal at Oklahoma Heart is to bring new devices and technologies to Tulsa, Northeast Oklahoma, and surrounding communities. So patients don’t have to suffer or undergo risky open-heart surgery or travel to another city like Dallas, Kansas City, or Chicago for treatment and a research study. Because We have the same studies that we’ve been doing in big centers and major cities here in Tulsa,” said Dr. Kamran Muhammad, cardiologist.
The Edwards PASCAL Precision System is used to treat patients at high risk for surgery in severe cases in which the heart valve does not close completely allowing blood to flow back into the heart.
“In the field of cardiology, we often deal with valvular heart disease and heart valves are very important because they open and close each time your heart compresses and allows blood to flow in a regulated direction from your heart,” said Dr. Mohammed.
Life looked a lot different two years ago for Benita Jaeger, who has a heart valve problem.
“Maybe I could walk from here to this chair and sit down to rest,” said Benita Yeager, a patient. “I was tired.” “It’s not alive. Sitting in a chair is out of place.”
Yeager said Dr. Mohamed gave her life back. It all started with a device called the PASCAL Precision designed to repair a patient’s mitral valve by reducing it or even preventing it from leaking.
“When you have a disease of the heart valves or you have a problem with one of the valves, it could be because the valve is not opening well or the valve is leaking. Here we were dealing with the problem of mitral valve leakage. We call that mitral valve regurgitation and when that happens the blood flows backward in the patient’s heart. Every time the heart beats.”
“I went to his office for an office call, and I want help, and I didn’t know I was going to be the first patient,” said Yeager. It has become only the second device available in the United States to treat this condition.”
Dr. Mohamed said the Oklahoma Heart Institute was one of two hospitals in Oklahoma and the only one in Tulsa participating in this major study.
Hillcrest Medical Center said FDA approval was based on results from the pivotal CLASP IID/IIF trial in 2021. The results of the CLASP IID study were presented and published at the TCT conference in Boston in September 2022.
“We were the first to implant this device in Oklahoma, and in fact we were the first to use this particular model of the PASCAL Precision device when it was rolled out to all study teams,” said Dr. Mohamed.
He said the device is a game-changer and allows for a faster recovery process, is less invasive and comes with fewer risks.
“It is a very mechanical issue and it has a mechanical fix,” Dr. Mohamed said. “We can go through the femoral vein and femoral vein and implant the device on the valve while the patient’s heart is beating without any open heart surgery and valve repair.”
“Go on, Dr. Mohammed,” said Yeager.
After her procedure last spring, Jaeger said she spent two nights in the hospital and two weeks in rehab.
“I’m here,” said Yeager. “I really feel like a new person, not young. 84, ha ha.” “There is a future out there for me.”
Dr. Mohamed said that the PASCAL Precision performs similarly to the MitraClip, which was approved in 2014. But he told us that there are some distinct differences such as the way it is designed, how it works, and its physical properties.
There is now a new device on the market that gives them more options for different anatomy, he said.
Dr. Mohamed said it is like having more tools in a toolbox and he thinks it will help a lot of people and will have a wide reach.