PulseCath B.V., a frontrunner in percutaneous ventricular assist devices for high-risk Percutaneous Coronary Interventions (PCIs), has announced the successful transition from the Medical Device Directive (MDD) CE marking to the Medical Device Regulation (EU) 2017/745 (MDR) for its groundbreaking product, the iVAC 2L System.

This certification signifies PulseCath's unwavering dedication to upholding the highest standards of quality and safety in medical device technology.

The iVAC 2L System, a percutaneous Mechanical Circulatory Support (MCS) device, is engineered to facilitate high-risk PCIs with unparalleled precision and efficiency. Its innovative design enables synchronization with the patient's natural cardiac rhythm, effectively pumping blood from the left ventricle to the aorta to maintain hemodynamic stability throughout the procedure.

Inserted through the femoral artery, the iVAC 2L catheter is positioned in the left ventricle, with its outlet valve strategically placed at the ascending aorta level. Upon activation, the external pump synchronizes with the patient's electrocardiogram or aortic pressure signal, ensuring seamless blood circulation throughout the intervention.

One of the standout features of the iVAC 2L System is its user-friendly design, which minimizes the learning curve for specialists. Assembly, preparation, and implantation techniques are streamlined and straightforward, enhancing efficiency and safety in complex interventions.

The potential impact of the iVAC 2L System on high-risk PCI patients is substantial. With recent advancements in interventional cardiology enabling PCI in patients with complex coronary artery disease, in-hospital mortality rates for high-risk PCI patients remain elevated. The iVAC 2L System aims to mitigate the risk of hemodynamic instability during coronary vessel manipulation, potentially reducing adverse outcomes associated with these procedures.

Oren Malchin, CEO of PulseCath, expressed enthusiasm about the MDR CE certification, emphasizing its significance for the company and the broader healthcare community. "This achievement represents a significant milestone for PulseCath," stated Malchin. "iVAC 2L signifies a leap forward in complex High-Risk PCI procedures, and we are eager to make this transformative device accessible to healthcare providers and patients worldwide."

With the MDR CE certification in place, PulseCath is poised to revolutionize the landscape of high-risk PCIs, offering a novel solution that prioritizes patient safety and procedural efficacy.