Dive Brief:
- Abiomed is narrowing the label for its Impella RP heart pump after a recent postmarket study showed a high mortality rate among patients who were not part of the initial approval group in 2017.
- According to the updated label, the pump should be used less than 48 hours after patients develop right heart failure, and should not be used in patients experiencing shock, end organ failure or acute neurologic injury.
- The Danvers, Massachusetts-based maker of heart devices agreed in early November to be acquired by Johnson & Johnson for $16.6 billion.
Dive Insight:
The decision appears to be a setback for Abiomed’s device, limiting the number of patients in whom it can be implanted.
The latest data, from the last of five post-market studies required by the FDA as part of Impella’s approval, showed a similarly low survival rate for patients in the expanded group beyond the original premarket study. In the latest results, of 33 patients who would have met the enrollment criteria, 69.7% survived after 30 days. The remaining 70 patients had a much lower survival rate of 18.6%.
The Food and Drug Administration approved the labeling changes on Tuesday, saying the labeling should “better reflect the characteristics of the patients who may benefit the most from treatment with the device.”
The study that led to the original approval for the device excluded patients who were in cardiogenic shock for more than 48 hours, or who had experienced in-hospital cardiac arrests. The new criteria limit the number of people who could be treated with the device — less than a third of patients in a previous post-market study met the requirements.
The regulator alerted cardiologists in 2019 after a previous postmarket study found that just 17% of patients survived, compared to the 73% survival rate Abiomed reported before the device gained FDA approval.
“[The] letter from the FDA is another affirmation by the FDA of the safety and efficacy of Impella RP,” the company said in a statement. “A 70% survival rate can be achieved in this very sick patient population when Impella RP therapy is initiated within 48 hours of the onset of right heart failure or decompensation.”
Abiomed brought in $263.25 million in product revenue last quarter, a 7.4% year-over-year increase. The company received FDA approval in October for its newest device, the Impella RP Flex, and the first patients were treated with it in November.
Update: Adds comment from company.
