Abiomed has achieved the CE mark for Impella Connect, which—a press release reports—is the first-of-its kind cloud-based technology that enables secure, real-time, remote viewing of the Impella console for physicians and hospital staff from anywhere with internet connectivity. The CE mark adds to Impella Connect’s previous US FDA PMA approval.
According to the press release, Impella Connect uses real-time intelligence to help improve patient outcomes. In addition to allowing medical professionals to view their hospital’s consoles remotely, Impella Connect 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.
Based on the previous FDA PMA approval, Impella Connect, which is fully HIPAA compliant, is in a limited market release in the USA. 36 hospital sites are currently using the technology on a regular basis to provide enhanced real-time support for their patients. Abiomed will launch Impella Connect in Europe this quarter through a controlled roll-out at hospital sites with established heart recovery protocols. The first hospital will be University Heart Center in Hamburg, Germany.
Rajeev Narayan (Vassar Brothers Medical Center, New York, USA) says: “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 haemodynamic support, in real time.”
Michael R Minogue, president, chairman and CEO of Abiomed, states: “Impella Connect is a technological advancement which represents the next frontier of heart recovery products,” said “Impella Connect, along with our 24×7 onsite and on-call support, enables physicians, nurses and ICU staff to increase productivity, improve patient outcomes, and help patients return home with their native heart.”