New Clinical Data Shows Abiomed Impella RP Heart Pump is Safe, Despite Concerns Over Patient Deaths: FDA

FDA says Abiomed Impella RP Heart Pump Systems are safe enough to use, but must be limited to specific patient populations.

Although federal health officials have expressed concerns about increased Abiomed Impella RP Heart Pump Systems mortality rates , the FDA now indicates the medical device is safe for use in patients meeting certain medical criteria.

The Abiomed Impella RP Heart Pump System is used as an emergency implant to improve right ventricular function of the heart. The implant is designed to pump blood from the vena cava through the heart and into the pulmonary arteries which lead to the lungs. It is often used for 14 days while patients are in the hospital awaiting treatment for heart transplant or implantation of a surgical right ventricular assist device (RVAD).

The FDA issued premarket approval of the Abiomed Impella RP Heart Pump System in September 2017, requiring the manufacturer to conduct a post-approval study (PAS) as a condition of approval for the Impella RP System, with the same primary endpoint as the premarket clinical studies.

However, interim results of the PAS released in 2019 found the devices were being used in a broader range of patient populations than previously restricted in the initial clinical trials. The findings further revealed an increased risk of death was associated with individuals receiving Impella RP Heart Pumps that did not meet the clinical trials patient criteria.

As a result, the FDA issued a Abiomed Impella RP Heart Pump System warning on May 21, 2019, alerting healthcare professionals of an increased rate of mortality associated with the use of the devices. Officials warned healthcare providers that if a patient would not have qualified for the clinical trials initially used to gain FDA approval, then they likely face an increased risk of death after being implanted with the heart pumps.

While early clinical trials of strictly qualifying patients showed a 73% survival rate, the interim results released in 2019 from real-world use identified only 28% of patients survived to the start of the next long-term therapy.

Abiomed Impella RP Heart Pump Label Update

Following the completion of the post-approval study, officials released an Approval Study Results and Updated Labeling communication to healthcare professionals on December 5, which warns against using the Abiomed Impella RP Heart Pump System in non-specified patient populations.

According to the notice, the updated labeling will now require the following usage guidelines for the device;

“The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open‐heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”

The new labeling now specifies the heart pump implants are to only be used in patients who have not experienced shock, organ failure or acute neurologic injury in conjunction with right-side heart failure.

The agency is instructing health care providers to read and follow the updated label-usage updates for the Impella RP System and to thoroughly discuss the benefits and risks of the devices with patients and their caregivers when making treatment decisions.

Any and all adverse events involving the Impella RP System should be reported to the agency to help the FDA identify and better understand the risks associated with medical devices.