Innovative Image Guided Device for Beating Heart Mitral Valve Repair

DESCRIPTION provided by applicant Mitral valve disease is the most prevalent heart valve dysfunction in the U S affecting approximately of the total population and of the population over age With the aging population the occurrence of severe mitral regurgitation MR in the U S and Europe is projected to exceed M by and will present an increasing economic burden The Problem MR causes a volume overload on the left ventricle which in turn progresses to ventricular dilation decreased ejection performance pulmonary hypertension symptomatic congestive heart failure atrial fibrillation right ventricular dysfunction and death While conventional mitral valve surgery is safe and effective it remains very invasive and morbid and is significantly underutilized The Solution Harpoon Medical has developed technology for minimally invasive image guided beating heart mitral valve repair performed via a keyhole incision between the ribs The innovative device allows an operator to eliminate MR by securing artificial chordae tendineae neochords to a prolapsed mitral valve leaflet with a bulky knot anchor and resuspending the leaflet in its normal position The Harpoon device eliminates the need crack the chest put the patient on a heart lung machine and stop the heart This will transform conventional mitral valve surgery from a complex hour operation to a sixty minute procedure and allow patients to return to normal daily activities within a week Preliminary Data An ongoing early feasibility study has confirmed that the Harpoon device successfully reduced severe MR to trace in two patients suffering from degenerative mitral valve disease Specific Aims This project entails the development work and preclinical testing necessary to create an automated delivery system for human trials in the U S and accelerate the commercialization of Harpoonandapos s minimally invasive beating heart mitral valve repair device In Specific Aim we will develop an automated delivery system with a single button actuator and validate it at the bench and in acute pig studies In Specific Aim we will develop a method for titrating the length of multiple neochords under echocardiographic guidance and securing them to the epicardial surface of the heart The automated delivery system developed in Aim and the method for titrating the length of the neochords developed in Aim will be evaluated as part of a clinical study in dogs with degenerative mitral valve disease in Specific Aim to validate the safety performance and efficacy of the device in a naturally occurring disease model Expected Outcomes At the end of this Direct to Phase II SBIR Grant Harpoon will have a minimally invasive beating heart mitral valve repair device that has been validated in acute and chronic animal studies and is ready for clinical testing in the U S to support FDA approval PUBLIC HEALTH RELEVANCE In this Direct to Phase II SBIR Harpoon Medical plans to develop a medical device for minimally invasive beating heart mitral valve repair performed via a keyhole incision between the ribs The device will transform conventional open heart surgery from a complex hour operation that requires a month or more for recovery to a simple minute procedure where the patient can return to normal daily activities within a week