PulseCath Achieves MDR CE Certification for iVAC 2L, Paving the Way for Complex High-Risk Percutaneous Coronary Interventions

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ARNHEM, Netherlands, March 11, 2024 /PRNewswire/ -- PulseCath B.V., a leader in the expanding field of percutaneous ventricular assist devices for high-risk PCI, proudly announces the successful achievement of the transition from Medical Device Directive (MDD) CE marking to Medical Device Regulation (EU) 2017/745 (MDR) for its groundbreaking product, iVAC 2L.

The MDR CE certification signifies PulseCath's commitment to the highest standards of quality and safety in medical devices.

The iVAC 2L System is a percutaneous Mechanical Circulatory Support (MCS) device. It can be used to facilitate high-risk Percutaneous Coronary Interventions (PCIs). The main advantage of iVAC 2L is that it pumps blood from the left ventricle to the aorta, synchronizing with the natural rhythm of the patient's cardiac cycle. It enables to perform the intervention with a circulatory back-up that keeps the patient hemodynamically stable.

The device is inserted through the femoral artery. The tip of the catheter containing the inlet is positioned in the left ventricle and the outlet valve is placed at the height of the ascending aorta, just at the level of the coronary ostia. The external pump is then activated, which synchronizes with the patient's electrocardiogram or aortic pressure signal, and pumps the blood for the duration of the entire treatment, aspirating the blood during systole and ejecting it to the ascending aorta during diastole. Once the high-risk treatment is over, the ventricular support is removed.

This technology does not require long learning curve from specialists, since its assembly and preparation are not complex compared to other similar devices. In addition, the implantation technique and catheter repositioning, if necessary, are fast, simple and safe.

What is the potential impact of the iVAC 2l System?

Recent technological developments in Interventional Cardiology have enabled PCI in patients with complex coronary artery disease. In-hospital mortality rate of high-risk PCI patients is higher than usual, and may reach 28% after 30 days^[1],[2]. The iVAC 2L System aims to reduce the risk of hemodynamical deterioration during manipulation of the coronary vessels^[2].

Mr. Oren Malchin, CEO of PulseCath, expressed excitement about the MDR CE certification, stating, "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."

About PulseCath:

PulseCath BV. is a Netherlands based medical device company that develops, manufactures and markets circulatory support systems. The company, formed in 2007, has developed unique and proprietary platform technology to provide a short-term circulatory support system for cardiologists and cardiac surgeons. The iVAC 2L is a Percutaneous Ventricular Assist Device, CE marked in 2014. In 27 EU countries, PulseCath has permission to market the iVAC 2L through the CE-mark. In 26 non-EU countries iVAC 2L has product registration. PulseCath has a worldwide distribution network.

The company is committed to the highest standards of quality, safety, and regulatory compliance.

For additional information, please visit: www.pulsecath.com.

References

^1. Almudarra, Sami S et al. "Comparative outcomes after unprotected left main stem percutaneous coronary intervention: a national linked cohort study of 5,065 acute and elective cases from the BCIS Registry (British Cardiovascular Intervention Society)." JACC. Cardiovascular interventions vol. 7,7 (2014): 717-30.
^2. Bastos, Marcelo B et al. "PulseCath iVAC2L: next-generation pulsatile mechanical circulatory support." Future cardiology vol. 16,2 (2020): 103-112.

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