Salt Lake City, UT (April 30th, 2020) - Following blind peer review, Second Heart Assist's clinical data presentation has been selected for oral presentation at the American Society of Artificial Organs (ASAIO) 66th annual conference, scheduled to be held entirely virtual by video June 10th-13th, 2020. The Second Heart Assist abstract will be published in the ASAIO Journal and will be a citable reference.
Dr. Leslie Miller, the Chief Medical Officer for Second Heart Assist, Inc., will be presenting the data on behalf of the clinical investigational team led by Dr. Adrian Ebner.
Second Heart Assist has developed both a catheter-based and a wireless-powered chronic implant circulatory assist device. Both of these devices have a firm fixation, true aortic stent that maintains positioning with security and also is able to maintain both aortic wall motion and blood flow pulsatility deemed essential for optimizing hemodynamics during long duration circulatory support. Both devices are placed via 14FR percutaneous delivery by a catheter inserted through the femoral artery. Multiple pre-clinical studies and a clinical pilot study confirmed under 5 minutes time to place the device in its intended position just above the renal arteries in the aorta. ?
Link to animation video demonstration Second Heart Assist aortic stent based circulatory assist pump deployment -
SHA Gen 1 Video FINAL from Brian Hardy on Vimeo.
"It is an honor to be presenting our first in human clinical data at the 66th ASAIO Annual Meeting and in their esteemed Journal. ASAIO provides an ideal forum for sharing "outside-the-box" breakthrough ideas and approaches to organ assist like our Second Heart Assist device", Jeff Donofrio, President Second Heart Assist, Inc.
"Every day, I work with patients that could use a better alternative to currently available technologies to recover from cardio-renal syndrome and I believe, based on early data, that the Second Heart Assist device lineup has a good chance to fill this great unmet need", Dr. Mark Cunningham, Cardiac Surgeon USC Keck Medical Center, Los Angeles, CA and Board Director Second Heart Assist, Inc.
ABOUT SECOND HEART ASSIST:
Second Heart Assist is developing the first 14FR catheter-deployed true aortic stent placed circulatory assist pump. The firm has a pioneering 2011 filed patent for wireless power. The device is primarily designed to rapidly remove excess fluids from cardio-renal syndrome heart failure patients, to revive their kidneys and for high risk PCI to protect the kidney from contrast toxicity. The product is also intended to off load the workload heart by reducing afterload while simultaneously improving blood flow to vital organs. This product is expected to be exceptionally useful as a minimally invasive treatment option for millions of diuretic resistant chronic heart failure patients in cardio-renal syndrome with both their hearts and kidneys failing. The core founding team at Second Heart Assist, Inc. previously developed the world's leading aortic stent graft system for endovascular aortic aneurysm repair and one of the first patented percutaneous delivered heart valves. For more information, visit our web site at www.secondheartinc.com The Second Heart Assist product developments are assisted by the Leonhardt's Launchpads innovation accelerator labs in California and Utah, see www.leonhardtventures.com.
Click here to access Leonhardt Ventures' and Leonhardt's Launchpads 2019/20 Annual Report https://leonhardtventures.com/wp-content/uploads/2020/04/4_23_2020.pdf
ABOUT ASAIO:
ASAIO’s mission is to provide a forum that globally and collaboratively promotes the development of innovative medical device technology at the crossroads of science, engineering, and medicine. Dedicated sessions are devoted to pediatric and adult mechanical circulatory support, respiratory assist, and VAD coordinator training. ASAIO (formerly known as the American Society for Artificial Internal Organs) is a world class society that has been in existence for over 64 years. It strives to "save lives one medical device at a time". ASAIO's mission is to provide a forum that globally and collaboratively promotes the development of innovative medical device technology at the crossroads of science, engineering, and medicine. This is synergistically accomplished by our interdisciplinary and talented membership comprised of clinicians, scientists, engineers, industry, academia, the financial community, as well as representatives from the Food & Drug Administration, National Science Foundation and the National Institutes of Health. Our interdisciplinary think-tank of developers push the envelope by continually adapting, evolving, and advancing the medical device, tissue engineering, and regenerative medicine fields to provide solutions that culminate in the development of novel life-saving technologies. ASAIO is deeply rooted in decades of history, success, and experience. We seek to challenge conventional wisdom, to carefully address technological limitations, and to formulate new solutions with life-changing potential.
ASAIO is the ideal home for visionaries with innovative ideas and young investigators eager to advance their careers. The Annual Conference provides a venue for young investigators to present early-stage research to an international audience receptive to new concepts in each of these fields. The Annual Conference also offers a one-of-a-kind opportunity to present new concepts to a seasoned audience to get real-time clinical, engineering and regulatory feedback on the viability of novel technology. The society takes pride in having "respect for all ideas", and in creating a culture that encourages interdisciplinary, mixing, blending, and out-of-the-box thinking.
Warning: Product is not yet proven either safe or effective and is only available for investigational use in selected countries where proper clearances have been or will be granted. Patents issued may not be maintained. Patents pending may not be issued. Company may be found to be infringing the patents of others. Forward looking information is subject to change without notice. Supply agreements may not be maintained.
