Abiomed's Impella RP Postapproval Study Data Presented at ACC

March 18, 2019—Abiomed announced that survival data from the 18-month postapproval study of 42 patients treated with the company's Impella RP heart pump were presented at the ACC's 68th Annual Scientific Session being held March 16–18 in New Orleans, Louisiana.

The percutaneous Impella RP technology received FDA premarket approval for right heart support. The Impella RP is approved to treat right heart failure or decompensation after left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Abiomed reviewed and submitted the postapproval study data to the FDA on March 13, 2019.

According to the company, the FDA has confirmed the classification of patients into two categories: Recover Right protocol and salvage support. The Recover Right protocol includes patients who met the inclusion and exclusion criteria of the Recover Right FDA PMA clinical trial for Impella RP. The FDA also recognizes salvage patients as those outside the Recover Right protocol (> 48 hours in cardiogenic shock from right side failure).

The baseline characteristics of the two populations were different with higher mortality in the salvage group. The company noted that salvage patients are some of the sickest patients in the hospital and many have suffered out-of-hospital cardiac arrest or may have been transferred to multiple hospitals before receiving Impella RP. The FDA and Abiomed believe that physicians should have the ability to attempt lifesaving recovery measures on these patients based on their best judgment.

The Impella RP postapproval study data compares to the following survival rates: 73% in the Impella RP PMA study, 42% for surgically implanted CentriMag RVAS HDE study protocol, and 29% to 42% self-reported survival to transfer or discharge for adult cardiac extracorporeal membrane oxygenation patients.

The Recover Right protocol matches the CentriMag surgical protocol defined by the FDA as right-side failure.

In the company's announcement, David Wohns, MD said, “When a patient is in right heart failure, Impella RP allows the heart to rest and recovers the heart’s ability to pump blood. The Impella RP is an effective treatment for patients who receive a timely implant and meet the Recover Right inclusion and exclusion criteria.”

Navin Kapur, MD, added, “The post-approval study data is analogous to our own independent data from multiple hospitals in the Cardiogenic Shock Working Group, which found an approximate 80% survival rate when the Impella RP was used in cardiogenic shock patients who met inclusion criteria from the Recover Right Study. Data like these highlight how the use of algorithms to recognize right sided failure and protocols for early hemodynamic support can help improve outcomes for cardiogenic shock patients.”