The technology is an endovascular non-arterial left ventricular assistance device to provide up to 10L/min of flow for intermediate and long-term use. The proposed IRONMAN device addresses these needs with a 30F self-centering transaortic catheter featuring an axial flow impeller capable of delivering up to 10 L/min. The device is powered by a subcutaneous generator in the right chest with wireless charging. The patent is licensed from Washington University in St. Louis and the Veteran’s Administration. There is a U.S. Patent Application No. 63/698,917 titled “Mechanical Cardiac Support Device and Methods of Using Same” filed September 25, 2024. There is an International Patent Application No. PCT/US2024/021079 titled “Mechanical Cardiac Support Device and Methods of Using Same” filed March 22, 2024 with priority to US Patent Application No. 63/491,585 filed March 22, 2023.
The implantation involves transseptal puncture and advancement of the device via the mitral and aortic valves, guided by imaging. This design leverages venous access to accommodate large-caliber catheters, reducing pump speed and shear stress, thereby enhancing durability and minimizing hemolysis. The intracorporeal approach eliminates the need for sternotomy and supports patient mobility. Initial prototypes developed using CFTurbo and modeled with Simerics CAD software required high speeds (30,000–50,000 rpm) to achieve target flow, prompting ongoing refinements to optimize hemodynamics and reduce shear.
Heart failure is a clinical syndrome characterized by inadequate cardiac output to meet the metabolic demands of vital organs. Patients often progress through various stages, with Stage C representing symptomatic heart failure and Stage D denoting end-stage disease. At Stage D of heart failure, symptoms significantly impair daily life and lead to recurrent hospitalizations despite optimal medical therapy. The prognosis for patients with Stage D heart failure is poor, with a median survival of less than two years. However, advanced therapies such as heart transplantation can extend survival to over 12 years. Durable mechanical circulatory support (MCS) devices like left ventricular assist devices (LVADs) serve as either destination therapy or a bridge to transplant. Unfortunately, many patients are ineligible for these interventions due to factors such as multiorgan failure, frailty, cardiac cachexia, or prior thoracic surgeries.
The Ironman device is intended to be a durable (yet reversible) support device that can be delivered via a catheter-based delivery, thus more tolerable in sicker patients. The device can be a destination therapy or a bridge to other advanced therapies allowing recovery / improvement in functional status of patients with advanced heart failure, which could allow them to become candidates for other advanced therapies including transplantation. This is currently an unmet need worldwide which the IronMan device can fill.
We are seeking an SBIR NIH FastTrack application for a January 2026 deadline. We will be exploring other grant options as well. We are also seeking license and collaboration opportunities with industry players and Angel / VC groups.
Earle Hager
Managing Partner
The Neutrino Donut, LLC / Neutrino Donut Heart Stent, LLC
Los Angeles / Austin / Omaha
+1 512-431-3940
The Neutrino Donut is a consultancy with a focus on technology commercialization. Our focus is on managing the development process for startups, understanding the use of grant processes, business development, and fundraising programs via Angel and Venture markets. We have worked with startups in all aspects of the development lifecycle. We have an extensive understanding of the ecosystems for universities, startups, grant programs, and global projects. We provide consulting services for partners as well as our own clients.
Earle Hager
Managing Partner
The Neutrino Donut, LLC
Los Angeles / Austin / Omaha
512-431-3940
