Abiomed (NSDQ:ABMD) said today that real-world data on its Impella RP heart pump showed a survival rate that matched that of its pre-approval study when following the FDA’s approved protocol for the device.
The Impella RP is designed to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. It won FDA approval in September 2017.
In May, the FDA reported a new 30-day survival rate of 28.6% for Impella RP patients post-explant, hospital discharge or the start of longer term therapy. That number was significantly lower than the 73.3% survival rate reported in the premarket clinical study of the device.
However, nearly two years of real-world data collected from physicians using the FDA’s approved protocol for Danvers, Mass.-based Abiomed’s Impella RP achieved 72% patient survival and 88% native heart recovery.
The FDA’s protocol includes recommendations on patient selection and timely identification of right heart failure with the subsequent implementation of Impella RP. The Cardiogenic Shock Working Group, the National Cardiogenic Shock Initiative Study and the cVAD Study all contributed recommendations as well.
Two classifications for Impella RP post-approval study patients were determined by the FDA: the recover right protocol and salvage support. Recover right patients are categorized as those who met the inclusion and exclusion criteria of the recover right FDA PMA clinical trial, while salvage support patients are considered outside the recover right protocol, having undergone more than 48 hours in cardiogenic shock from right side failure. Salvage support patients are some of the sickest in the hospital and have a higher mortality, according to a news release.
“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,” chief medical officer Dr. Seth Bilazarian said in prepared remarks. “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.”
“When right-sided heart failure is identified early, it is reversable and heart recovery is possible,” added Tufts Medical Center CardioVascular Center for Research & Innovation Dr. Navin Kapur. “Elevated RA pressure in a patient with cardiogenic shock is a warning sign that a patient is at an increased risk of dying and should trigger a comprehensive evaluation for underlying causes including right heart failure. If right heart dysfunction is identified, therapy should be escalated to manage this issue as soon as possible.”
Shares of ABMD were up 0.1% at $180.13 per share in early-morning trading today.