PulseCath’s iVAC 2L Percutaneous Ventricular Assist Device Achieves MDR CE Certification in Europe

March 11, 2024—PulseCath BV, a Netherlands-based developer of percutaneous ventricular assist devices for high-risk percutaneous coronary interventions (PCI), announced the transition from the European Union’s Medical Device Directive CE Mark to the Medical Device Regulation (EU) 2017/745 for its iVAC 2L device.

The iVAC 2L percutaneous ventricular assist device first received CE Mark approval in 2014 and may be marketed in 27 countries in the European Union. Additionally, iVAC 2L has product registration in 26 countries outside the European Union. PulseCath has a worldwide distribution network, noted the company.

According to PulseCath, the iVAC 2L percutaneous mechanical circulatory support device can be used to facilitate high-risk PCIs. Inserted through the femoral artery, the iVAC 2L pumps blood from the left ventricle to the aorta, synchronizing with the natural rhythm of the patient’s cardiac cycle. It enables the performance of an intervention with a circulatory backup that keeps the patient hemodynamically stable. The system aims to reduce the risk of hemodynamical deterioration during manipulation of the coronary vessels.