Abiomed scores FDA approval for easier-to-wear pump for right-side heart failure

Abiomed has received FDA approval for a new model of its minimally invasive cardiac pump targeting the right side of the heart, allowing for a new approach the company says will make it easier for patients to walk while implanted with the device. 

The Impella RP Flex is inserted through the jugular vein in the neck, as opposed to up through blood vessels in the thigh with its predecessor, the Impella RP. The catheter-based device is then threaded into the heart’s chambers to help mechanically support blood flow and take some of the strain off the beating cardiac muscle. 

The device was given premarket approval by the FDA for treating acute, right-side heart failure for up to two weeks, the company said in a release. The temporary assistance is designed to aid patients who develop the condition after suffering a heart attack, or following open surgery, a heart transplant or the implantation of a left ventricular assist device, known as an LVAD.

During right-side heart failure, blood that should be pumped into the lungs to pick up oxygen starts to back up into the heart, ultimately causing blood pressure and swelling to rise in the body’s veins. 

The latest generation of the Impella RP was approved by the FDA in June 2021; the device also received an emergency authorization from the agency the year before for COVID-19 patients suffering from right-side heart failure, including those with a pulmonary embolism.

The system is designed to pick up blood from the large vena cava leading into the heart and conveying it through the right atrium and ventricle through a tube before pumping it out to the pulmonary artery, bypassing the organ and pushing blood toward the lungs at a rate of more than 4 liters per minute. 

Abiomed plans to introduce the Impella RP Flex in the U.S. through a controlled rollout before the end of this year. The device also includes the company’s SmartAssist technology, which links two embedded sensors to a real-time patient monitoring platform that helps track blood flow and inform healthcare providers of the best time to begin weaning the patient off the support system.

Elsewhere in its pipeline, Abiomed is developing approaches to treating respiratory failure and kidney failure, as well as a pump-based therapy for deadly heart attacks caused by a completely blocked coronary artery, known as a STEMI.

The company has been leading a randomized, controlled trial since late 2019 in patients suffering from a STEMI heart attack, with patients split into two groups. 

One arm has been receiving the standard of care, with immediate reperfusion treatments to help restore the flow of blood to the heart—while the other has clinicians first use the Impella CP pump to take the workload off the heart’s left ventricle for 30 minutes before beginning reperfusion therapy. The study will look to see if this method reduces damage to heart tissue after a myocardial infarction and its effects on future rates of heart failure.

“This speaks to how Abiomed is going to really swing for the fences,” said Matt Gaylord, Abiomed’s director of business development, during a presentation at the AdvaMed Medtech Conference in Boston Oct. 24. “That’s 30 or 40 years of gold-standard treatment that we're trying to upend.”