Impella Connect Cloud-Based Monitoring Platform Approved in Europe
January 31, 2019—Abiomed announced it has received European CE Mark approval for its Impella Connect, a cloud-based technology that enables secure, real-time, remote viewing of the Impella console for physicians and hospital staff from anywhere with internet connectivity.
With the Impella Connect, medical professionals can view their hospital’s consoles remotely. Additionally, the technology allows highly trained staff at Abiomed’s 24/7 Clinical Support Center to provide medical professionals with expert evaluation of Impella data and real-time collaborative patient management.
Abiomed will launch Impella Connect in Europe in Q1 2019 through a controlled roll-out at hospital sites with established heart recovery protocols. The first hospital will be University Heart Center in Hamburg, Germany.
The Impella Connect previously received FDA premarket approval in the United States. Impella Connect, which is fully HIPAA compliant, is in a limited market release in the United States. The Impella 2.5 and Impella CP devices are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions.
Rajeev L. Narayan, MD, commented in the company's announcement, “Impella Connect is an extremely valuable resource that allows me, as well as allied health professionals and nursing staff, to have direct visualization of data from the Impella console and to closely monitor patients on hemodynamic support, in real time.” Dr. Narayan is Assistant Director of Structural Heart Intervention and Director Interventional Mechanical Circulatory Support at Vassar Brothers Medical Center in Poughkeepsie, New York.