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More patients getting this heart pump are dying

This week, the FDA warned heart doctors that patients who had received a newer type of heart pump, called the Impella RP, were dying at much higher rates in the real world than in initial clinical trials.

Why it matters: Experts have long said medical devices that pose the most risk and treat complex conditions need stricter regulation. But the development around this heart device also shows how a lack of rigorous testing causes confusion about whether devices are beneficial and working as intended.

Details: In 2017, the FDA approved the Impella RP device, which helps pump blood in the right side of the heart and is made by Abiomed. Small studies showed 73% of patients who got the pump were still alive within a month. However:

  • The combined sample size was 60 patients, and trials were not randomized.
  • Half of the patients still encountered "major bleeding."
  • The trials did not account for "patient perspectives," such as whether patients were in pain.

Driving the news: The FDA required Abiomed, which has $780 million in annual sales, to track patients who received the device. The results aren't good.

  • The survival rate has dropped precipitously — just 4 of 23 patients (17%) who got the Impella RP were alive within a month.
  • Since 2015, there have been 21 adverse events linked to the Impella RP, including 3 deaths, according to federal data analyzed by Madris Tomes, a former FDA regulator who founded the software firm Device Events.
  • Her analysis, shared with Axios, indicated 10 of those adverse events occurred in 2018.

Yes, but: The FDA and Abiomed both said patients in the post-approval study were a lot sicker than people who were in the original studies — making it unclear whether the heart device had hurt or helped. The FDA and Abiomed also developed a checklist to help doctors determine which patients are best suited for the device.

  • If patients were critically ill or already close to death, using the heart pump would be like "throwing a Hail Mary," and doesn't demonstrate whether the patient would have benefited from the device, said Robert Yeh, an interventional cardiologist in Boston who has used the Impella.

The big picture: Devices often make it to market without a lot of data proving their safety or effectiveness, and post-market studies don't necessarily show that either.

  • "We don't have great randomized trials ... for many of the devices like Impella. As a result, we are left to a data-free zone," said Yeh, who has received money from heart device makers.

Go deeper: The International Consortium of Investigative Journalists published a series on medical devices that explained how devices have a lower bar for clinical safety and effectiveness than drugs.

Editor's note: This piece was corrected to show that there were 21 Impella RP adverse events, including 3 deaths (not 23 adverse events with 5 deaths).