Surgeries & Interventions

Abiomed’s Impella Achievements

Abiomed

Abiomed is celebrating a string of Impella achievements this month, including a new FDA clearance, favorable study results, and, perhaps most importantly, the final wrap-up of Impella’s post-approval studies. 

Post-Approval Studies – Since Impella’s pre-market approval in 2015, Abiomed has run five post-approval studies to satisfy the FDA’s request for additional data, following a series of studies that suggested the Impella pump was inferior to the IABP pump.

  • The FDA has now accepted and closed the post-approval studies covering Impella’s use in high-risk PCI, cardiogenic shock, post-cardiotomy cardiogenic shock, and right heart failure. 

New Publication – JACC published an observational study of US claims data that linked Impella to better survival in high-risk PCI patients than the IABP device. The large-scale study investigated patients who underwent nonemergent high-risk PCI with Impella (n=1,447) or IABP (n=709).

  • Unadjusted in-hospital survival was higher in Impella users compared with IABP (95.3% vs. 91.0%)
  • Even after adjusting for baseline clinical and procedure differences, Impella was still associated with improved survival (odds ratio: 1.55), as well as fewer cases of MI (OR: 0.29) and cardiogenic shock (OR: 0.54).  
  • Stroke, bleeding requiring transfusion, and acute kidney injury were similar between groups.

FDA Clearance – To top it off, the FDA has granted 510(k) clearance to Abiomed for its Impella Low Profile Sheath, which is specifically engineered to be compatible with the Impella single-access technique. 

The Takeaway

Abiomed’s Impella device started on wobbly ground, but new data coupled with the FDA’s satisfaction should provide renewed confidence in the heart pump. 

Get the top cardiology stories right in your inbox

You're signed up!

It's great to have you as a reader. Check your inbox for a welcome email.

-- The Cardiac Wire Team