The invention of circulatory support systems in cardiac cases back in the 1950s opened many avenues for doctors and researchers to explore the heart, its related conditions, and their treatment comprehensively. However, today, most cardiac assist devices that are currently in the market follow a continuous flow approach that involves rotors and impellers rotating at high rates to maintain circulation. This approach taken by the traditional circulatory support systems can cause adverse effects in the long run, and therefore, doctors and clinicians alike, are now looking for a solution that employs an innovative approach to achieve stable cardiac output combined with substantial blood pressure in a heart failing patient. By developing a unique solution to provide short-term circulatory systems for cardiologists and heart surgeons, PulseCath brings healthcare providers a simpler, cost-effective, and safer way to maintain circulation.
“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.
Additionally, the Ivac 2L is triggered by a ECG signal that analyzes the functionality of a patient’s heart. After analysis, during systole the device unload the remaining blood that the sick heart cannot eject, into the membrane pump, and pushes up to 40cc blood via unique 2 way valve located at ascending aorta and reintroduces additional volume into the circulatory system when the heart undergoes diastole.
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.
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