Press Release – Asuncion, Paraguay and Salt Lake City, Utah /PRDistribution/ — Second Heart Assist, Inc., an innovator in the field of circulatory assist support, has successfully completed its first clinical use of its aortic stent circulatory assist pump.
The landmark procedure was performed at the Italian Hospital in Asuncion, Paraguay by Dr. Adrian Ebner, a certified interventional cardiologist, cardiothoracic surgeon and vascular surgeon, under the supervision of cardiologist Dr. Leslie Miller Chief Medical Officer of Second Heart Assist, Inc. “This pioneering successful percutaneous implant of a true aortic stent-based circulatory assist pump represents a potential breakthrough in treatment of patients at risk for kidney injury during high risk PCI, and may ultimately lead to the potential use of this product for treating patients with cardio-renal dysfunction”, said Dr. Leslie Miller.
“Having a true aortic stent, with sufficient radial force to stabilize securely position, is a breakthrough that could potentially lead to more successful patient outcomes with less un-intended repositioning. Most devices used today have no fixation strength or are dependent on hooks that have their own unique potential complications,” stated Alex Richardson, Vice President of Engineering & Product Development, Second Heart Assist, Inc.
“The ability to deliver a gold standard for circulatory assist — a migration resistant device with high flows at low RPMs (which potentially may minimize risk of hemolysis) — via a truly percutaneous femoral artery approach — has the potential to expand options for patients around the world,” said Dr. Leslie Miller. “The device met or exceeded all performance parameters expected including an aortic pressure differential of 10 to 13mm Hg, with lower pressure above the device and higher pressure below the device due to increased aortic blood flow, throughout the procedure at impeller RPMs of under 10,000 . Furthermore we witnessed a more than 250% increase in urine output from the hour before the procedure to the hour during the procedure. We are extremely pleased with the outcome of this landmark case”, continued Dr. Miller.
Additional device placements are scheduled to take place this week. This first case was completed with a 13.5mm impeller designed for smaller patients. One of the upcoming cases will be completed with a 14.5mm impeller which in pre-clinical studies was associated with a 20% greater improvement in flows at the same or lower (7000) RPM speed.
This implant is a another step towards our goal to provide the first non-surgical wireless powered circulatory assist pump which can be easily placed and removed as needed for long term support of chronic heart failure patients. The percutaneous placement via the femoral artery to a position just above the renal arteries in the aorta took less than one minute, a testament to its simplicity in design and function”, stated Howard Leonhardt, Executive Chairman and CEO of Second Heart Assist, Inc., who attended this historic procedure with Dr. Ebner. Leonhardt is the inventor of the aortic stent used in the procedure.
The Second Heart Assist device is a true aortic stent-based circulatory assist pump designed to protect the kidney from contrast-induced injury during complex high risk PCI cases and to increase perfusion. It is also is designed to help reverse cardio renal dysfunction in patients hospitalized with decompensating heart failure to remove excess fluids more rapidly and to recover kidney function, to potentially reduce hospitalization time. This is the first circulatory assist pump within an atraumatic high radial force self-affixing nitinol aortic stent intended to reduce the risk of unintended migration and need for time consuming repositioning which has been noted in some cases with other devices. Having self-affixing properties puts this device in the ideal position to make the transition to wireless power, the primary goal for the next generation Second Heart Assist development team. The team announced earlier this year the first successful pre-clinical demonstration of wireless power of its device at the Queensland University of Technology (QUT) in Brisbane, Australia.
About Second Heart Assist, Inc.:
Second Heart Assist (www.secondheartinc.com) mission is to develop the gold standard for circulatory assist support devices, and has R&D lab facilities in Salt Lake City, Utah and Los Angeles, California.
SOURCE: Second Heart Assist, Inc.
Warnings and Disclaimers: This device is not yet proven safe or effective. Available for investigational use only. Forward looking statements are subject to change without notice.