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A Change Is Coming for Abiomed’s Impella RP System Indication

FDA said it is updating the indications for use statement to better reflect the characteristics of the patients who may benefit the most from treatment with the device.

Omar Ford

December 5, 2022

2 Min Read
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Image courtesy of Casimiro / Alamy Stock Photo

FDA is narrowing the label indication for Abiomed’s Impella RP System. The watchdog agency’s measure comes a little more than a month after Johnson & Johnson announced it would acquire the Danvers, MA-based company for $16.6 billion.

FDA’s decision is based on results from the final results of a post-approval study (PAS) of the device. The final PAS results show that the survival rate for the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies is consistent with the premarket clinical studies survival rate and further confirms that the device is safe and effective when used for the currently approved indication.

In an update published Monday, FDA wrote 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.”

Results of the study show that the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies, 23 out of 33 evaluable patients (69.7 percent) survived to 30 days after device explant or hospital discharge (whichever was longer), or to the start of next longer-term therapy. This survival rate is consistent with the premarket clinical study’s survival rate.

Results also show that of PAS patients who would not have qualified for the premarket clinical studies, the corresponding survival rate was 18.6% (13 out of 70 evaluable patients). In these patients, the PAS survival rate should be interpreted in the context of the patients' conditions and limited treatment options.

Outside of being an M&A target for J&J, 2022 has been a busy year for Abiomed. The company won two FDA nods for trials related to clinical research of the Impella heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients.

The company also announced a subgroup analysis within its PROTECT 11 study included 93 non-Caucasian patients who are at high risk for PCI, and showed better outcomes with the Impella pump.

Abiomed kicked off 2022 by reporting successful results of the VENUS-HF Early feasibility study of the precardiac system.

The study examined 30 patients with ADHF who were assigned preCARDIA therapy for 12 or 24 hours. The primary endpoint was a composite of major adverse events through 30 days.

Abiomed first won approval for the Impella RP in 2017.

 

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].

 

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