FDA Warns Against Off-Indication Use of Abiomed Impella RP System

Susan Jeffrey

Disclosures

May 21, 2019

The US Food and Drug Administration issued an updated letter to healthcare providers to disclose interim results from a post-approval study (PAS) of Abiomed Impella RP heart pump system.

"These latest interim results, which are available on the FDA Post-Approval Studies webpage, indicate a lower survival rate for the subgroup of PAS patients who would not have qualified for the premarket clinical studies compared to the premarket clinical study survival rate," the letter notes.

"Based on our current analysis, the FDA believes that when the device is used for the currently approved indication in appropriately selected patients the benefits of the Impella RP System continue to outweigh the risks."

The letter updates a previous letter sent February 4, 2019, to healthcare providers. The latest letter was sent May 21 to cardiologists, cardiothoracic surgeons, and transplant surgeons.

Interim Results

The FDA granted premarket approval of the Impella RP System in 2017, with an indication 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 following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

This recent report shows that 12 out of 42 patients (28.6%) enrolled in the PAS survived to 30 days post device explant or hospital discharge, or to the start of next longer term therapy, the letter notes. Premarket clinical studies had shown a survival rate of 73.3%. "The FDA worked with Abiomed to explore subgroup analyses of the PAS results," the agency writes.

The primary reason they found to explain this difference in survival was patient selection, they note. "For the subgroup of PAS patients who would not have met the enrollment criteria for the premarket clinical studies, the survival rate was 64.3% (9 out of 14 patients) which is similar to the premarket clinical survival rate," the letter says. "For the subgroup of PAS patients who would not have qualified for the premarket clinical studies, the survival rate was 10.7% (3 out of 28 patients).

"In these patients, the PAS survival rate should be interpreted in the context of the patients' conditions and limited treatment options," the FDA letter adds.

Those patients who would not have qualified for the premarket clinical studies were more likely to have been in cardiogenic shock for more 48 hours, have experienced a cardiac arrest, or have suffered a pre-implant hypoxic or ischemic neurologic event before implantation of the Impella RP System vs those who would have met enrollment criteria, they note.

The post-market study and the FDA's evaluation are ongoing, they conclude. "The FDA will continue to work with Abiomed to monitor the survival rate in the Impella RP System PAS."

In April 2019, the FDA approved revised labeling for Abiomed's Impella RP System to include more information about patient selection and which patients may benefit the most from treatment with the device. In addition, the FDA required Abiomed to make changes to the design of the PAS to include subgroup analyses and to establish a minimum number of patients in each subgroup, the agency notes. Details of the study protocol are posted on the FDA's Post-Approval Studies webpage, the agency said.

In the meantime, the FDA continues to recommend that healthcare providers:

  • "Be aware that the FDA approval of the Impella RP System was based on the results of premarket clinical studies that included patients who had been in cardiogenic shock for less than 48 hours prior to device implant. Additionally, none of the patients in the premarket clinical studies experienced an in-hospital cardiac arrest, or were treated with an intra-aortic balloon pump, or suffered a hypoxic or ischemic neurologic event, prior to Impella RP being implanted. Although these clinical events may not preclude a clinical decision to use the device, physicians should be aware that the occurrence of one or more of these events prior to Impella RP implantation may decrease expected survival rate."

  • "Carefully consider these interim survival results from the ongoing PAS when making treatment decisions and discuss the risks and benefits of the Impella RP System with patients and their caregivers. Additionally, be aware that there are currently no other device interventions that have been approved by the FDA under the premarket application (PMA) process for the patient population demonstrating a higher mortality rate in the PAS. As such, other interventions may include their own benefits and risks that should be considered and discussed with patients and their caregivers."

In a statement, Abiomed says the new FDA letter "validates that Abiomed's Impella RP heart pump is safe and effective for treatment of right heart failure."

"The FDA letter emphasizes the need for early patient selection and determines late identification and treatment of cardiogenic shock as the root cause of differences between the survival rate in the premarket study and the PAS," the company adds.

"The FDA has no safety concerns about the Impella RP itself and noted the ongoing collaboration between the agency and Abiomed during this process, including interactive labeling updates around patient selection guidelines and best practices. The 18-month PAS report has been accepted by the FDA and is successfully closed."

Any adverse events or suspected adverse events with the system should be submitted through MedWatch, the FDA safety information and adverse event reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting regulations, and healthcare personnel employed by facilities subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities, the letter notes.

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