“Unlike other cardiac assist devices, our product employs a natural pulsatile support that is synchronized with the heartbeats of a patient, to work combined with the heart and not as an individual system,” says Oren Malkin, vice president of marketing and sales at PulseCath. One of the significant advantages of PulseCath’s products is increasing patients’ hemodynamic performance, improving circulatory and coronary flow and blood pressure with very low rate of RBC destruction (hemolysis), which is a drawback in circulatory-assist devices that utilize impellers. PulseCath’s Ivac 2L system comprises, a catheter that is inserted into the left ventricle via percutaneous procedure from femoral artery and a membrane pump located outside of body driven by a standard intra-aortic balloon console that already available in every cardiac clinic.
Founded in 2007, PulseCath carried out R&D on cardiac-assist systems for 10 years before starting product sales in August 2017. Initially, the products developed by the company were designed to be used in surgical procedures, and not by interventional cardiologists. This meant that the older generation of products required invasive surgery to be utilized and warranted at least two days in the ICU to ensure proper healing. However, due to the increased risk of complications caused by the surgical procedure, the risk-benefit ratio of the previous products was unbalanced. This led PulseCath to shift their focus into the development of a safer, easy-to-use, and straightforward product. The company achieved this by downsizing the outer diameter of the catheter, increasing the length of the product, and eliminating the need for invading the chest by delivering the product from the femoral artery.
PulseCath’s move to a percutaneous approach opened a new segment concerning target patients as they could now assist doctors to perform a percutaneous coronary intervention on high-risk patients. “Using our circulatory-assist device as a safety net keeps the patient hemodynamics very stable during the manipulation of a high-risk procedure, gives the doctor the ability to perform in a low-stress environment, and delivers the best solution for the patient,” explains Malkin. Additionally, PulseCath’s products also assist doctors in reducing the extracorporeal mechanical oxygenation (ECMO) support in patients by effectively unloading the ventricle of a patient’s heart.
Currently, PulseCath is focusing on collecting clinical data, as Malkin believes that gathering the necessary evidence through clinical studies and publications is vital in developing the products that fulfill client demands. PulseCath recently registered a patent for their latest product, which is set to hit the market in the next 24 months. “The new product will have a smaller diameter, higher powerful ejection, and will work with the heart by providing pulsatile support,” adds Malkin. Looking ahead, the company plans to collaborate with a US-based company to help PulseCath run clinical studies, acquire rights for distribution, and get the FDA-approval, before launching into the US markets.