PulseCath
Revolutionising Mechanical Circulatory Support

According to World Health Organization, cardiovascular diseases (CVDs) are the leading cause of death globally, taking an estimated 17.9 million lives each year. While there has been a greater focus on research and scientific advancements aimed at understanding the diverse aspects of these diseases, the technological progress in regards to sustainable surgical processes has been considerably slow. Cardiologists and clinicians are thereby making all possible attempts to develop novel treatment solutions that include minimally invasive approaches, ventricular unloading in combination with end-organ reperfusion, early institution of circulatory support, and others that facilitate intelligent decisionmaking and reduce the high incidence of morbidity and mortality due to heart failure in patients. Set against this backdrop of changing tides, PulseCath is contributing to these advances by developing ground-breaking technologies designed to assist the life-sustaining pumping functions of the failing heart. On a mission to deliver novel solutions that reduce health care costs and improve patient outcomes, PulseCath is committed to developing, manufacturing and marketing innovative circulatory support systems.

Through series of relentless clinical studies and multicentre research, PulseCath has built iVAC 2L, a short-term, fully percutaneous, 17Fr. transfemoral LVAD that effectively generates blood flow up to 2 litres per minute. iVAC 2L provides pulsatile cardiac support during high-risk PCI procedures in terms of pressure-volume loop analysis, effect on the myocardium energy, and oxygen consumption, and thereby supports active unloading of ventricles. “Our device considerably reduces the energy consumption of the myocardial unloading of the left ventricle doing the pumping and parallelly, increases the total cardiac output and augments aortic pressure,” begins Oren Malkin, VP, PulseCath. These unique elements of the device have been instrumental in stabilising the hemodynamic situation of the patient during high-risk revascularisation procedures such as high-risk PCI, acute myocardial infarction, and cardiogenic shock, among others.

Malkin emphasises that iVAC 2L was designed keeping in mind the complications that arise with using a percutaneous ventricular assist device during and after a high-risk PCI procedure. iVAC 2L eliminates these complexities, which include accidental blockage of stents or arteries that might occur during PCI operations, and thereby, reduces the chances of critical conditions for fragile/critical patients. The uniqueness of PulseCath’s innovative iVAC 2L stems from the fact that it is a pulsatile synchronised system that works conjointly with the body and not as separate equipment.

Our device considerably reduces the energy consumption of the myocardial unloading of the left ventricle doing the pumping and parallelly, increases the total cardiac output and augments aortic pressure

Unlike the traditionally used pump devices that ensure continuous flow, iVAC 2L synchronises itself with the natural physiology of the patient’s heart. Precisely, it acts as the artificial upper arm in the aorta and helps the heart to eject, unload, work, and pump normally. Malkin explains that in the systolic phase of a cardiac cycle, blood is aspirated from the left ventricle through the catheter tip and lumen into the membrane pump. This blood is then ejected by the membrane pump through the catheter, as a result of which the catheter valve opens to deliver the blood to the ascending aorta through the side outflow port, thereby creating an “extra beat of the heart”. The pulsatile synchronisation eliminates the risk of impairing the aortic valve function. In addition, iVAC 2L has even helped cardiologists revive patients during open-heart surgeries in extreme cases where lung machines fail.

Apart from the impeccable benefits that the iVAC 2L brings to the table, the device has also gained an edge over the competition with its user-intuitiveness, costeffectiveness, and quick learning curve. Malkin informs that iVAC 2L simple catheter design and zero electronic complexity makes it easy to insert and activate in the human body. In fact, to help customers easily install the product, the company offers elementary online support. A feather to its cap is the affordability of iVAC 2L that makes it accessible to slow-growth economies like Hungary, Croatia, Slovakia, Slovenia, and more.

An exemplification of iVAC 2L’s stellar potentialities is the recent case study wherein Dr Martín Valdebenito Tepper and his team from Hospital Sótero del Río, Chile, performed the first successful iVAC2L procedure on a 55-year-old patient n South America. The individual was known to be suffering from hypertension, unprotected LM, and multi-vessel disease with a heart performance rate as low as 15 percent. Together with his team and PulseCath partners ARLAB SA., Dr Tepper deployed seven stents, LM, LAD, 1DG, LCX, RCA and was able to hemodynamically stabilise the patient with iVAC2L support.

This is but one of the many success stories that PulseCath has scripted at the behest of its robust solution. With innovation at its core, the company is looking forward to collaborating with a Chinese company, Huadong Medicine, to spread its footprints across three levels– investment, marketing and sales, and local manufacturing. Besides, PulseCath is going the extra mile to leverage cutting-edge technology at an affordable rate in underdeveloped countries and, in turn, boost their medical infrastructure. “We are trying hard to find ways together with the locals in these countries to bring them not only the technology and its unprecedented benefits that established firms enjoy, but also the products/solutions that augment their economical framework,” concludes Malkin. With a strong value proposition in place, PulseCath is all set to expand its global distribution, fostering innovation and new products to become the world’s circulatory support leader.