CORISMA MCS SYSTEMS INC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

ABSTRACT Heart failure (HF), a global pandemic affecting 23 million people worldwide and 6 million in the US, with 650,000 new cases diagnosed in the US each year. It is a relentless disease that progresses to end stages with very poor prognosis, in which heart transplantation or left ventricular assist device (LVAD) therapy becomes the only available treatment option. A significant rise in the LVAD use for end-stage HF is due to critical donor shortage. However, continuous pump operation, 24/7/365, with no ability to maintain or clean the pump leads to clots, stroke, and infection, which greatly limits the clinical benefit. This is akin to driving a car without changing its oil and filter or doing any maintenance for five to ten years. Not only is regular pump maintenance necessary for cars, it is also an essential and standard practice in the entire pump industry to keep them running properly. However, current LVADs do not have access to clean the pump once it is implanted unless another highly invasive open-heart surgery is performed. Device durability to ensure 24/7/365 continuous operation without mechanical failure has been the major technical focus throughout generations of LVAD, which comes at the price of invasiveness, 24-hour care, infection, bleeding, thrombosis, and reduced quality of life for the remainder of the patient’s life. Ability to clean and maintain the LVAD in-vivo may completely change the management of LVAD patients. Clinical experience demonstrates that an LVAD can be safely turned off for short durations while supporting circulation with inotropes, giving an opportunity to clean and carry out maintenance in-vivo. Bonde Innovations LLC and the Artificial Heart Laboratory at Yale University have developed a VAD maintenance system incorporating a unique component called BiO-valve (Balloon isolation Occluding valves) that can isolate the pump in-vivo and allows to clean, maintain, and service the pump when it is still implanted within a human body. Two BiO-valves are connected to a single access port designed to control all four steps of the procedure - isolation, purging, maintenance, and service with no exposure to blood or body fluids. It is a simple all-in-one unit applicable to any implantable VAD. In this SBIR phase I proposal, we will demonstrate the feasibility of in-vivo VAD maintenance system, and then plan to submit a Phase II proposal to develop product level of VAD maintenance system through design optimization, design freeze, and extensive pre-clinical studies to make it ready for clinical trials. An unprecedented opportunity of providing routine pump maintenance in-vivo has potential to reduce common and severe complications, promote patient recovery, and shorten hospitalizations, bringing innovations in VAD technology and management.PROJECT NARRATIVE Investigators at Bonde Innovations LLC and the Artificial Heart Laboratory at Yale University have developed a VAD maintenance system incorporating a unique component called BiO-valve that can isolate the pump in-vivo and allows cleaning, maintainence, and servicing of the pump when it is still implanted within a human body, vastly improving VAD management. The in-vivo VAD maintenance system is a promising novel solution to the issues of clots, strokes, and infections associated with current VADs.