December 5, 2022 The U.S. Food and Drug Administration (FDA) is issuing this update to our previous letter to health care providersExternal Link Disclaimer to inform the health care community of the final post-approval study (PAS) results and updated labeling for the Impella RP System manufactured by Abiomed. 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. On December 5, 2022, the FDA approved updated labeling for the Impella RP System, based on the PAS results, with an update to the indications for use statement to better reflect the characteristics of the patients who may benefit the most from treatment with the device. Recommendations The FDA recommends health care providers: Read and follow the updated labeling for the Impella RP System, which includes an update to the indications for use statement to better reflect which patients may benefit the most from treatment with the Impella RP System. Discuss the benefits and risks of the device with patients and their caregivers when making treatment decisions. Report any adverse events experienced with the Impella RP System to the FDA. Refer to the Reporting Problems to the FDA section below. Background The FDA approved the premarket application for the Impella RP System in September 2017. The device is implanted percutaneously to help patients who require temporary emergency support of the right ventricular function of the heart. Use of the device, which may be up to 14 days, requires patients to stay in the hospital. In the premarket clinical studies, where strict inclusion and exclusion criteria were followed, a total of 44 out of 60 patients (73.3 percent) survived to 30 days after device explant or hospital discharge (whichever was longer), or to the start of next longer-term therapy, including heart transplant or implantation of a surgical right ventricular assist device (RVAD), which was the primary endpoint. The FDA required the manufacturer, Abiomed, 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. Early interim results from the PAS, which reflected device use in a broader patient population in the real world, suggested a higher mortality rate for patients treated with the Impella RP System than the rate previously observed in the premarket clinical studies. The FDA worked with Abiomed to explore subgroup analyses of the PAS results and to monitor the survival rate in the Impella RP System PAS. Post-Approval Study (PAS) Results for Impella RP System: The PAS for the Impella RP System has been completed and a summary of the final results is available in the FDA’s PAS Database. Below is a high-level summary of the final results for the primary endpoint: For 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 studies survival rate. For the subgroup of PAS patients who would not have qualified for the premarket clinical studies, the corresponding survival rate was 18.6 percent (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. PAS patients who would not have qualified for the premarket clinical studies were more likely to have been in acute right heart failure or decompensation for longer than 48 hours and experienced a severe cardiogenic shock, end organ failure, or acute neurologic injury, compared to the PAS patients who would have met the enrollment criteria for the premarket clinical studies. Updated Impella RP System Labeling On December 5, 2022, the FDA approved updated labeling for the Impella RP System to include the results from the post-approval study (PAS), and an update to the indications for use statement to better reflect which patients may benefit the most from treatment with the Impella RP System based on the outcomes observed in the PAS. The italicized information below reflects the updates made to the indications for use statement: “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 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. FDA Actions The FDA will continue to work with the manufacturer to monitor reports of adverse events for the Impella RP System and ensure that health care providers are informed about the intended use of the device. The FDA will keep the public informed if any significant new information becomes available. Reporting Problems to the FDA The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with the Impella RP System. Voluntary reports can 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 (MDR) regulations. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Contact Information If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).