Abiomed heart pump gets FDA approval
Abiomed Inc. has been granted approval by the FDA to provide its newest heart pump, the Impella RP, to hospitals around the country.
Abiomed, the medical implant manufacturer, located at 22 Cherry Hill Drive in Danvers, received the approval by the U.S. Food and Drug Administration under a Humanitarian Device Exemption.
The ruling came in January after a study of the device found patients had a 72 percent overall survival rate recovering from traumatic heart complications with the Impella RP. Abiomed will have to conduct two post-approval studies to ensure the safety of Impella RP.
The Impella RP is a first in the field of cardiothoracic surgery. It’s a device that can be implanted surgically or percutaneously, which simply means it can be inserted through the skin, up the femoral vein and directly into the heart. No invasive surgery is necessary, and the procedure can take as little as 20 minutes.
Abiomed had already invented four pumps dedicated to helping out left-sided heart function, as the left side of the heart fails much more often than the right side. This is the first pump dedicated solely to assisting function on the right side of the heart.
The purpose of the pump is to temporarily take over the function of an ailing right ventricle, the part of the heart responsible for pumping deoxygenated blood out of the heart and into the lungs. It can be utilized for a few hours or up to as many as 14 days.
It can be used on it’s own to stabilize a patient undergoing a procedure or it can used in accordance with other pumps to help a patient who is experiencing multiple types of heart problems.
Steve Zimmerman was one patient who had the Impella RP inserted into his heart.
In Zimmerman’s case, his heart was only functioning at 10 percent after multiple heart attacks. He developed right-sided heart failure in addition to left-sided failure. At one point his problems got so bad that he told his wife to just put him in hospice care and be done with it.
However, he was able to receive the Impella RP as a trial patient and, in accordance with a long-term heart pump to support the left side of his heart, made a full recovery. He even went back to the job he had prior to his brush with death.
“They said they could give it a shot so I said, ‘Go ahead,’” said Zimmerman. “The other option might have been to go into hospice and meet my demise. [Now] I feel like I’ve never had a problem.”
Dr. Mark Anderson of Einstein Medical Center in Pennsylvania performed the procedure on Zimmerman.
“We were able to put this new pump in him and support him for a couple of days and nurse him through the acute right-sided failure. Obviously ultimately he recovered, we took the pump out and he’s doing very well,” said Anderson.
Anderson has worked with many Impella devices in the past, and says that the Impella RP is an important step forward in medical science.
“It’s a major breakthrough for us and how we’re able to handle patients with acute heart failure. We had tools for the left side but we didn’t really have anything that was percutaneous, powerful, safe, and effective for the right side of the heart, and now we do,” he said.
“In essence we can support both sides of the heart now and we don’t have to open somebody’s chest or use a big surgical device. We’re able to treat patients now quickly and in a less invasive manner with very powerful devices that completely support the cardiac function, so it’s definitely a game changer for what we’re doing.”
Headquartered in Danvers, Abiomed was founded in 1981 and holds the title to many medical distinctions, including the inventions of the world’s first device allowing patients to recover quicker by walking after treatment, the world’s first totally artificial heart, and the world’s smallest heart pump.