Abiomed Introduces Single-Access Procedure With the Impella CP Introducer Sheaths in Europe

March 4, 2021—Abiomed announced that it is introducing the single-access procedure with Impella CP introducer sheaths for the treatment of heart disease in Europe. The decision comes after consultation with the notified body, Medcert Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH. Abiomed’s European headquarters are in Aachen, Germany.

Medcert is designated as a notified body by Germany to determine whether medical devices comply with European Union directives and regulations. Medcert has now confirmed to Abiomed that the single-access procedure is possible in Europe.

According to Abiomed, the confirmation given by Medcert for the single-access procedure gives cardiologists in Europe the option of performing interventional treatments for severe cardiac diseases via just one access site. The company noted that this method may be beneficial for patients with limited vascular access and may reduce potential complications using only one access site.

The single-access procedure enables the treating physician to place Abiomed’s Impella heart pumps in the ventricle via the 14-F Impella CP introducer sheaths and to insert other catheters and introducer sheaths. Thus, cardiac interventions such as percutaneous coronary intervention can also be performed via the 14-F Impella CP introducer sheaths. The procedure is practiced in the United States, where it was incorporated into Impella CP’s labeling in January 2020, noted Abiomed.