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.
