A device used for the first time in the world by cardiologists at the Oklahoma Heart Institute at Hillcrest Medical Center has received FDA clearance.
“Our goal at Oklahoma Heart is really to bring new devices and technology to Tulsa and northeast Oklahoma and surrounding communities. So patients don’t have to suffer or they don’t have to go through risky open heart surgery or traveling to another city like Dallas or Kansas City or Chicago to get treatment and a research study Because we have the same studies they have in the big centers and big cities here in Tulsa,” said cardiologist Dr. Kamran Muhammad.
The Edwards PASCAL precision system is used to treat patients at high risk for surgery in severe cases where the heart valve does not close completely, allowing blood to return to the heart.
“In the field of cardiology, we often deal with heart valve disease and heart valves are very important because they open and close each time your heart constricts and they allow blood to flow in an orderly direction out of your heart. from your heart,” says Dr Muhammad.
Life was very different two years ago for Bennetta Yaeger, who has a valvular heart problem.
“I could probably walk from here to this chair and sit down to rest. I was tired,” said patient Bennetta Yaeger. “That’s not living. Sitting in a chair isn’t where it’s at.”
Yaeger said Dr. Muhammad gave him back his life. It all started with a device called PASCAL Precision designed to repair a patient’s mitral valve by decreasing or even preventing leaks.
“When you have valvular heart disease or a problem with one of your valves, the valve may not open well or the valve may leak. Here we were dealing with a leak problem of the mitral valve. We call this mitral regurgitation and when this happens, blood rushes back into the patient’s heart with every heartbeat,” Dr Muhammad said.
“I went into his office for an office call, wanting help, not knowing that I would be the first patient,” Yaeger said. “It has become only the second device available in the United States to treat this condition.”
Dr. Muhammad said the Oklahoma Heart Institute was one of two hospitals in Oklahoma and the only one in Tulsa to participate in this major study.
Hillcrest Medical Center said the FDA approval was based on results from the pivotal CLASP IID/IIF trial in 2021. Results from the CLASP IID study were presented and published at the TCT conference in Boston in September 2022.
“We were the first to implement this device in Oklahoma and in fact we were the first in the world to use this particular model of the PASCAL Precision device when it was deployed across all study teams” , said Dr. Muhammad.
He said the device is a game-changer and allows for a faster recovery process, is far less invasive and carries less risk.
“It’s a very mechanical problem that has a mechanical solution,” Dr Muhammad said. “We can go through the inguinal vein, the femoral vein and implant the device on the valve while the patient’s heart is beating without any open-heart surgery and repair the valve.”
“Keep on going, Dr. Muhammad,” Yaeger said.
Yaeger said after her surgery last spring, she spent two nights in the hospital and a few weeks in rehab.
“I’m here. I really feel like a new person, and I’m not young. 84 years old, ha-ha,” Yaeger said. “There is a future there for me.”
Dr. Muhammad said PASCAL Precision works the same as the MitraClip, which was approved in 2014. But he told us there are distinct differences such as how it is designed, how it works and what properties it has. physical.
He said there is now a new device on the market that gives them more options for various autonomies.
Dr Muhammad said it’s like having more tools in a toolbox and thinks it will help a lot of people and have a wide reach.
Click here for more information on the device.