PulseCath this week announced it received CE mark approval for its iVAC 2L percutaneous mechanical circulatory support device.
The iVAC 2L device helps facilitate high-risk percutaneous coronary interventions. PulseCath designed it to pump blood from the left ventricle to the aorta in synchronization with the natural rhythm of the patient’s cardiac cycle. It provides the circulatory backup that keeps a patient hemodynamically stable.
“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 PCIs, and we are eager to make this transformative device available to healthcare providers and patients worldwide,” CEO Oren Malchin said in a news release.
How the iVAC 2L works
The device is inserted through the femoral artery and the tip of the catheter, which has the inlet, is positioned in the left ventricle. The outlet valve is placed at the height of the ascending aorta at the level of the coronary ostia. Then, the physician activates the external pump that synchronizes with the patient’s electrocardiogram or aortic pressure signal to pump the blood for the duration of the treatment. PulseCath’s device aspirates blood during systole and ejects it to the ascending aorta during diastole. Once the treatment is finished, ventricular support can be removed.
iVAC 2L does not require a long learning curve from specialists, according to the company. The assembly and preparation are not complex compared to other similar devices. The implantation technique and catheter repositioning are fast, simple and safe.
