Abiomed Hits TCT 2019 Running with Compelling Data and New Approval

Abiomed certainly brought its A-game to the 31st annual Transcatheter Cardiovascular Therapeutics (TCT) conference- being held now and throughout the weekend. The Danvers, MA-based company came armed with the news of a newly-approved device and data from its PROTECT III trial, an ongoing prospective, single-arm FDA post-market study for the Impella 2.5 and Impella CP in high-risk PCI. Abiomed, which was named one of the top 25 M&A targets in medtech, said an interim analysis of 898 patients from the PROTECT III trial demonstrated a reduction in the primary endpoint of death, stroke, myocardial infarction, and repeat procedures at 90 days with Impella-supported Protected PCI, compared to PROTECT II. PROTECT III is part of a series of FDA clinical studies, which includes PROTECT I, and the PROTECT II RCT. The company said this is the largest-ever FDA study of hemodynamically supported high-risk PCI patients and the series has enrolled 1,366 patients as of July. “The patient population that has been studied in this series of trials that are PROTECT, have never been studied by anyone before,” Seth Bilazarian, CMO, of Abiomed, told MD+DI. “We have higher risks with the aging of the population, and more extensive disease with many patients heart failure. Because of the growing epidemic of heart failure, many of these patients haven’t even been evaluated before.” Patients in PROTECT III are...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news