The survival rate of right-heart failure patients treated with the Abiomed (NSDQ:ABMD) Impella RP heart pump remained about the same during the latest round of post-approval studies, according to the FDA.
That latest rate of survival 30 days post-explant, post-discharge survival or switch to another therapy rate was 72.7%, or 16 out of 22 patients among those who would have met the enrollment criteria for the premarket clinical studies. This compares with the 73.3% rate among those who met the same criteria and participated in those premarket studies, the agency noted.
Among patients who would not have qualified for Impella RP using the preclinical trial criteria, the most current survival rate was 13.6%, or six out of 44 patients. This latter group includes patients who were more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a pre-implant hypoxic or ischemic neurologic event before having Impella implanted, the FDA said. A total of 60 patients are enrolled in the study.
The agency said in February that it was concerned with the 17% overall survival rate of Impella RP post-approval study patients, of whom four out of 23 had met the primary survival endpoint. In April, the FDA approved revised labeling for Impella RP to include more information about patient selection and which patients may benefit the most from treatment with the device. The agency also required Abiomed to make changes to the design of the post-approval study to include subgroup analyses, and to establish a minimum number of patients in each subgroup. Details of the study protocol are posted on the FDA’s post-approval studies webpage.
Abiomed said that nearly two years of real-world outcomes on its Impella RP heart pump show that when physicians followed the FDA’s approved protocol for Impella RP use, which includes early identification of right heart failure and early implantation of Impella RP, they achieved 72% patient survival and 88% native heart recovery. Investigators and thought leaders in the field of cardiogenic shock have made multiple recommendations based on data sets which demonstrate late identification of right heart failure is associated with increased mortality, the company added.
“We are pleased to see the numerical increase in survival for both the Recover Right and salvage populations in the Impella RP post approval study,” added Dr. Seth Bilazarian, an interventional cardiologist and Abiomed’s chief medical officer, in an email to MassDevice. “The FDA’s letters to health care providers earlier this year have helped Abiomed and the post-approval study principal investigators educate other medical providers on the importance of using simple identifiers to achieve timely identification of right side heart failure in the catheterization lab and ICU.”
In a May 21 letter to cardiologists, cardiothoracic surgeons and and transplant surgeons, the agency said it believed 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.
Abiomed won clearance for the Impella RP in September of 2017, and it remains the only device with FDA premarket approval for right-side heart support. Much like the company’s flagship Impella heart pump, the Impella RP is threaded into the heart via the femoral artery in the thigh. But unlike previous Impella models, all designed for the heart’s left ventricle, the Impella RP is designed to access the heart’s right ventricle via the vena cava.
The next post-approval study report on Impella RP is due March 20, 2020. The FDA said it will continue to post interim results from the ongoing study on the post-approval studies webpage.
Shares of ABMD took a 20% hit Nov. 18 after new research suggested potentially serious complications involving the company’s Impella heart pumps. Abiomed said at the time that the research was flawed.
Shares of ABMD were trading down 0.68% at $190.92 at noon today.
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