Clinical Accelerator and Second Heart Assist have recently entered into an exciting new collaboration, focused on developing a novel device for heart failure patients. An early feasibility trial will be conducted on Second Heart’s aortic stent based circulatory assist pump. The company is developing both a temporary use catheter-based device and a wireless powered chronic implant. The objective is to improve quality of life of heart failure patients by reducing the heart’s workload and improving organ perfusion. Renal function is also expected to be enhanced which reduces the risks that come with toxic contrasts used in percutaneous catheterization interventions (High Risk PCI). The product will also help patients to recover from cardiogenic shock and attain normal hemodynamics for acute decompensating heart failure patients.
Heart Failure is a severe problem that currently affects over 6 million people in the U.S. alone. Many patients cannot receive a heart transplant and therefore are instead reliant on cardiac assist devices. A major issue is that currently available circulatory assist devices have limitations such as device-associated thrombosis, and there are also risks and complications that can come with invasive implantation procedures that are often needed for many devices. Second Heart’s technology overcomes many of the limitations that are associated with other devices as it involves easy and secure placement in the aorta, provides high flow rates and minimizes risk of thrombosis with thrombosis-resistant material. The aortic stent design in this device is also currently the only one that is known to combine both high security of fixation stability and also maintenance of pulsatile aortic wall movement (which can potentially be essential to successful long-term chronic implant)
About Second Heart Assist
Second Heart Assist is a development stage company dedicated to developing the world’s first percutaneously placed true aortic stent based circulatory assist pumps. The company has two advanced platforms for three cardiovascular clinical endpoints and markets: (PCI, CRS, Class III HF). The platforms are a catheter-based device and a wireless power chronic device, both of which utilize their pulsatile-conforming aortic radial stent. Second Heart Assist is part of Leonhardt Ventures – a venture creation lab focused on advancing regenerative medtech innovations. It was founded by Howard J. Leonhardt, inventor and serial entrepreneur who has 21 U.S. patents and over 100 patent claims for products treating cardiovascular disease. Supervising the project is Dr. Les Miller, a prominent heart failure cardiologist and CMO of Second Heart Assist.
About Clinical Accelerator
Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech companies. The organization was founded by a heart failure cardiologist and performs many clinical investigations of cardiovascular medical devices, with a special focus on heart failure. Studies are mostly implemented in Central and Eastern Europe, a region with well-known advantages for clinical trials such as – fast start-up timelines and good access to patients. Clinical Accelerator aims to accelerate clinical development programs of international medical technology companies through early entry into the clinic and fast and efficient implementation of both feasibility and pivotal clinical investigations.