Early development testing of innovative circulatory assist device results show promise
Boston, Mass. and Salt Lake City, Utah – October 19th, 2017 (PRBUZZ)– Second Heart Assist, Inc. today announced the first successful implant of its Second Heart Assist, Inc. Gen. I Circulatory Support Assist device, in relevant preclinical models performed at Tufts Medical Center, in Boston, Massachusetts by Dr. Navin K. Kapur, Executive Director, The Cardiovascular Center for Research and Innovation (CVCRI); Director, Acute Mechanical Circulatory Support Program; Director, Interventional Cardiology Research Laboratories; Associate Professor, Tufts University School of Medicine
This is the first Second Heart Assist, Inc. preclinical implant since successful completion of prototype development and full series of bench studies.
Second Heart Assist, Inc. has entered into agreement with Tufts Medical Center to complete Phase I (verification flow rates) and Phase II (durability, safety and full performance testing) and will proceed to Phase III GLP study.
Second Heart Assist, Inc. intends to utilize this data combined with our bench data as well as other safety related data to apply to the FDA to complete an Early Feasibility Study in 10 to 30 patients in 2018.
“The Second Heart Assist devices are designed to give end stage heart failure patients another treatment option to extend their quality of life when they are ineligible for all other medical therapies. The design is intended to be especially well suited for helping patients recover from cardio-renal dysfunction.” Dr. Leslie Miller, Chief Medical Officer, Second Heart Assist, Inc.
“We are honored to be among the few distinguished institutions in the nation involved with the early evaluation of this new technology,” said Dr. Kapur. “The implantation marks the culmination of decades of research and development and has the potential to one day become an option for heart failure patients, particularly those suffering from cardio-renal dysfunction. This early testing is a significant milestone towards offering new hope for patients in great need. We look forward to completing the next phases of planned preclinical studies.”
The Second Heart Assist, Inc. team is developing two models of their device.
I. Circulatory assist pump within a bare aortic stent at tip of a 13.8FR catheter for temporary support.
II. Wireless powered chronic implant that is removable and has both continuous and pulsatile flow.
Both devices are placed in the descending aorta just below the diaphragm and just above the renal arteries. The aortic stents occupy the entire aortic inner diameter unlike competitive systems that occupy only a portion of the inner aortic diameter. This permits higher flow rates at lower RPMs. The Second Heart Assist 1st generation device is achieving 4.5 liters per minute flow @ 4500 RPMs and the 2nd generation device is expected to reach this flow rate at as low as 1500 RPMs. This is substantially lower than the 33,000 to 80,000 RPMS required by other competitive devices to achieve 4.5 liters per minute true in patient flow at the level of the renal arteries. Both models of the Second Heart Assist devices are supported by Leonhardt’s patent pending VibroCell vibrational harmonic resonance energy technology for preventing blood clot formations and bioelectric energy transmitting micro coil implants along the stent to control protein expressions, action potentials and pressures within the aortic wall. The 2nd generation device includes patented wireless pulsating aortic stent graft technology and bladeless circulatory assist support with expected low hemolysis rates licensed via an exclusive option from Caltech (California Institute of Technology) in Pasadena, CA.
About Second Heart Assist, Inc.: Founded in Salt Lake City, Utah in late 2015 by the same team that developed the leading endovascular stent graft systems and the first percutaneous heart valve. Focused on the development of circulatory assist pumps within aortic stents. The company has research locations in both California and Utah with experienced consulting advisors from around the world. The Second Heart Assist, Inc. device product line was originally developed as a support device for the BioLeonhardt www.bioleonhardt.com heart regeneration implant comprised of a bioelectric stimulator and re-fillable micro infusion pump the size of a quarter designed to regenerate failing hearts over a 36 month course of treatment. See www.secondheartinc.com
About Leonhardt Ventures: Founded in 1982 (HJ Leonhardt & Co.) and formed into an LLC in 2005 (Leonhardt Vineyards LLC DBA Leonhardt Ventures) as the commercialization arm of inventor Howard J. Leonhardt. Leonhardt has 21 issued U.S. patents for organ regeneration and recovery devices and dozens more patent claims pending currently at the UPSTO – https://patents.justia.com/inventor/howard-j-leonhardt. In the 1980’s the Leonhardt team patented and pioneered the developed of predictably compliant cardiovascular balloon catheters – PolyCath TM and turn key cardiac cath labs. In the 1990’s they developed the first commercially successfull stent graft for aortic aneurysm repair without surgery TALENT TM and the first percutaneous heart valve. Their research team members completed the first stem cell repair of animal heart in 1988 and the landmark first ever non-surgical stem cell repair of a human heart in 2001. They published their first bioelectric organ regeneration paper in 1999 in CIRCULATION. Since 1999 the focus of the organization has been on bioelectric, stem cell and growth factor based organ regeneration product development and research supported by micro pump and endovascular catheter technologies. See www.leonhardtventures.com
About Leonhardt’s Launchpads: Leonhardt’s Launchpads is the innovation and startup accelerator arm of Leonhardt Ventures. They opened up in 2008 at the University of Northern California Science & Technology Innovation Center near Santa Rosa, CA in 2013 in Santa Monica and in 2015 in Salt Lake City, Utah. They currently incubate 27 regenerative medtech and 3 regenerative economy startups. The business model is to advance each organ specific innovation and startup through first-in-man results and then seek a strategic partner.
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