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 statistically older (71 years), include more women (26%) and non-Caucasians (33%), received longer support and had more complex procedures with more vessels treated than patients in PROTECT II. Yet the 90-day MACCE rate in PROTECT III is lower than the intra-aortic balloon pump (IABP) control arm from PROTECT II. The composite MACCE rate in the IABP arm was 31%, compared to the Impella 2.5 and Impella CP arm at 16.8% (p<0.0001).
“I’m very proud of the fact that we have invested in not only developing this therapeutic area for patients in need but also are continuing to invest in collecting contemporary data in real-world settings for patients that are being treated,” Bilazarian said.
Abiomed also touted the approval of the Impella 5.5 with SmartAssist heart pump. The Impella 5.5 with SmartAssist System is intended for the short term (14 days). The company said the device delivers peak flows of greater than six liters per minute. It added that a motor housing that is thinner and 45% shorter than the Impella 5.0 improves ease of pump insertion through the vasculature.
The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
“A minimally invasive, forward flow, fully unloading heart pump that is designed for surgery is game-changing,” Mark Anderson, MD, chief of the Division of Cardiac Surgery and cardiothoracic surgeon at the Heart and Vascular Hospital at Hackensack University Medical Center and Hackensack Meridian Health, said in a release. “This gives cardiac surgeons a new and potentially better option that can provide the benefits of heart recovery to some of our sickest patients.”