PulseCath said that it has transitioned from Medical Device Directive (MDD) CE marking to Medical Device Regulation (EU) 2017/745 (MDR) for its percutaneous mechanical circulatory support (MCS) device, iVAC 2L.
The iVAC 2L System is designed to facilitate high-risk percutaneous coronary interventions (PCIs). Initially, the device secured CE marking in 2014.
PulseCath, which is based in the Netherlands, develops percutaneous ventricular assist devices for high-risk PCI.
Its MCS device pumps blood from the left ventricle to the aorta to match the natural rhythm of the patient’s cardiac cycle.
According to PulseCath, iVAC 2L carries out the intervention while maintaining the patient’s haemodynamic stability through a circulatory backup.
The device is inserted via the femoral artery. The outlet valve is positioned at the level of the coronary ostia, at the height of the ascending aorta, while the tip of the catheter with the inlet is positioned in the left ventricle.
After that, the external pump is activated to synchronise with the patient’s ECG or aortic pressure signal.
It pumps the blood throughout the treatment to aspirate blood during systole and ejects it to the ascending aorta during diastole, PulseCath said.
Ventricular support is discontinued after the high-risk treatment is finished.
PulseCath CEO Oren Malchin said: “This achievement marks a significant milestone for PulseCath and underscores our commitment to delivering innovative solutions that meet the highest regulatory standards.
“iVAC 2L represents a leap forward in complex High-Risk PCI’s, and we are eager to make this transformative device available to healthcare providers and patients worldwide.”
The Dutch medical device firm said that the technology does not need a lengthy learning curve from experts as its preparation and assembly are simpler than those of other comparable devices.
Furthermore, the implantation process is quick, easy, and safe, as is the repositioning of the catheter if needed.
The goal of the iVAC 2L System is to lower the possibility of haemodynamic degradation when manipulating the coronary arteries.
