First Long-Duration Clinical Studies in Cardio-Renal Syndrome Patients Now Scheduled to Take Place July 2020 in Tbilisi, Georgia
NEWS PROVIDED BY Second Heart Assist, Inc. June 22nd, 2020 7:00am ET
Salt Lake City, Utah, June 22nd, 2020 /PRDistribution/ -- Second Heart Assist Inc., inventors of the first, true, aortic stent-based circulatory assist pump intended primarily for use in heart failure patients, announces the successful completion of a series of long-duration preclinical studies in pulsatile mock loop and bovine models. Long-duration studies were completed using mock-loop apparatuses at the University of Louisville (Louisville, KY), ViVitro Labs (Victoria, BC, Canada), and Biomerics (Minneapolis, MN) as well as in large animal models at Q Test (Columbus, OH), APS (Minneapolis, MN) and the Texas Heart Institute (Houston, TX). These successful studies pave the way for upcoming, first-in-human clinical studies in diuretic resistant heart failure patients suffering from cardio-renal syndrome—to be performed in Tbilisi, Georgia in July 2020. It is planned that OUS first-in-human studies will be followed by a US-based Early Feasibility Study (EFS).
"The recent successful completion of these long-duration in vivo studies, utilizing the percutaneously delivered Second Heart Assist circulatory assist pump within a true aortic stent, demonstrates the desired durability needed to address an increasing patient population suffering from advanced heart failure.” stated Alex Richardson, Chief Technology Officer and Vice President of Engineering Second Heart Assist, Inc. who was present and actively participated in all preclinical studies. “These preclinical studies demonstrated position stability and robust blood flow improvement provided by our system. We are particularly excited about the excellent outcomes we saw during long-duration studies where we noted minimal hemolysis and only minor clinically insignificant thrombus formation after over 40 hours of operation." Richardson further stated, “These studies, again, give evidence to the advantages of the unique design for our catheter-based product. Furthermore, we have adapted this same mechanical stent and impeller pump platform for use in our chronic wireless device, which we are actively building and testing, to target additional therapeutic endpoints."
"The Second Heart Assist product lineup introduces a unique solution for patients suffering from diuretic resistance resulting in cardio-renal syndrome by providing strong improvements to renal function, while offloading the heart. The strong radial force of the aortic stent minimizes risk of migration experienced by other available device designs." stated Jeff Donofrio President, who was present for the Texas Heart Institute study.
Dr. Brett Burton, VP of R&D at Second Heart Assist, explained: "Our device is unique in that it not only occupies the entire aorta, but it is also designed to safely distend the vessel by about 2 mm. This design ensures that, once properly positioned and deployed, our device maintains a robust intervascular fixation within the aorta (just above the renal arteries). In addition to secure device positioning, the large cross-sectional area produced by the open stent allows for the unimpeded flow of blood within the vessel and provides a space in which our impeller can operate safely, effectively, and, at low RPMs, to generate high flow to the renal arteries.”
Dr. Leslie Miller, Chief Medical Officer (CMO) of Second Heart Assist commented, "We are thrilled to have reached this milestone, which further validates the safety and efficacy of our technology, particularly in preclinical settings, and supports our intent to now move into longer duration clinical studies."
Dr. Mark Cunningham, Chief Cardiac Surgery Advisor, Board Director, and Cardiac Surgeon at USC Keck Medical Center, and who also assisted in the recent 40+ hour Texas Heart Institute study, stated "I see patients every week, including those receiving ineffective inotropic support (of which decreased renal function is a characteristic). Many of these patients could benefit greatly from the Second Heart Assist circulatory assist pump, designed to deliver continuous and reliable renal support while maintaining consistent positioning through its aortic stent technology platform. The 2nd generation wireless powered chronic implant in development represents a potentially huge leap forward."
Clinical Accelerator, Inc. has been engaged as the Contract Research Organization (CRO) to help implement the OUS cardio-renal syndrome heart failure clinical study including data collection and analysis - https://clinicalaccelerator.com/cro-services/
In 2019 the Second Heart Assist team previously announced results from a positive short-duration pilot first-in-human clinical study - https://secondheartinc.com/second-heart-assist-announces-landmark-successful-first-in-human-non-surgical-placement-of-an-aortic-stent-based-circulatory-assist-pump/. This clinical data has been presented at the Heart Failure Society of America, TCT Cardiology, Devices for Heart Failure and ASAIO Annual Meetings.
The team also announced recent progress on the development of its wireless powered chronic product-https://secondheartinc.com/second-heart-assist-to-unveil-updated-wireless-power-design-at-asaio-annual-meeting/
SHA Gen 1 Video FINAL from Brian Hardy on Vimeo.
About Second Heart Assist:
Second Heart Assist, Inc. is a Utah corporation founded in 2016 focused on development of a circulatory assist pump within an aortic stent within the Leonhardt's Launchpads www.leonhardtventures.com innovation and startup accelerator(s). See www.secondheartinc.com for more information.
Disclaimer: Forward looking information is subject to change without notice. Product is not yet proven to be safe or effective. Product is still in early stage of development and pathway to commercialization. The company lacks sufficient resources at this time to bring product to commercialization. Patents pending may not be issued. Patents issued may be invalidated. Patents optioned or licensed may not be maintained. As an investment Second Heart Assist must be regarded in highest risk category for total loss. No other group has succeeded in developing a wireless power chronic circulatory assist device with success as the obstacles to doing so are tremendous. Available for investigational use only in locations where proper regulatory clearance has been granted.
