Monday, March 11, 2024
PulseCath BV, a leader in the field of percutaneous ventricular assist devices for high-risk PCI, proudly announces its successful transition from CE marking of the Medical Devices Directive (MDD) to the Medical Devices Regulation (EU) 2017/745 (MDR) for its innovative product, iVAC 2L. The attainment of MDR-CE certification underscores PulseCath's unwavering commitment to upholding the highest standards of quality and safety in medical device manufacturing.
The iVAC 2L system serves as a percutaneous mechanical circulatory support (MCS) device, specifically designed to facilitate high-risk percutaneous coronary interventions (PCIs). Its unique functionality involves pumping blood from the left ventricle into the aorta, synchronizing with the patient's cardiac cycle to maintain hemodynamic stability during procedures.
The device is inserted via the femoral artery, with its inlet valve positioned in the left ventricle and the outlet valve placed at the level of the ascending aorta, precisely aligned with the coronary ostia. Operated in coordination with the patient's electrocardiogram or aortic pressure signal, the iVAC 2L system effectively manages blood flow, ensuring optimal support throughout the intervention. Notably, the device boasts user-friendly assembly, straightforward implantation techniques, and quick repositioning of the catheter, thereby minimizing the learning curve for healthcare professionals.
In the evolving landscape of interventional cardiology, recent advancements have expanded the scope of PCI for patients with complex coronary artery disease. However, high-risk PCI procedures carry elevated in-hospital mortality rates, highlighting the critical need for innovations like the iVAC 2L system to mitigate hemodynamic instability during coronary artery manipulation. This achievement represents a significant milestone for PulseCath, affirming our dedication to delivering innovative solutions that adhere to the highest regulatory standards and advance the field of complex, high-risk PCIs.
Source: prnewswire.com
