Catheter Based Cardiovascular Device Retrieval System

Recent advances in technology have made possible the treatment of a growing number of structural cardiovascular diseases by catheter based procedures. Atrial septal defects (ASD), ventricular septal defects (VSD), aortic aneurysm, congenital defects and valve disease are all currently being treated with catheter based strategies. These procedures are complex and are prone to device misplacement, even by experienced operators. Currently remedial surgical procedures are required to retrieve misplaced devices. A transcatheter retrieval system would represent a major advance that would spare patients the pain of remedial surgical procedures and provide a “safety net” that promotes the use of these less invasive procedures and expands the number of patients who benefit from them. Onocor has begun development of such retrieval system. The Onocor system consists of (1) customized co-axial catheter for introduction of the system and recovery of the target implant, (2) a novel nitinol wire woven basket designed to envelope, compress and retrieve the target implant, (3) mechanical advantage system for steady application of the withdraw force and (4) manipulation tools to aid in orienting the target implant. In preliminary work, carried out in Phase I, we have demonstrated the effectiveness of the basket in compressing large stents (aortic valve frames, aortic aneurysm stents). The efficacy of the retrieval system in removing many types of misplaced cardiovascular devices has also been extensively demonstrated in animal models. The goal of the current Phase II STTR proposal is to refine the design concept to the point of first-in-man applicationsA growing number of cardiovascular diseases are now treatable by transcatheter therapy. These procedures are complex and prone to device misplacement, even by experienced operators. Currently remedial surgical procedures are required to retrieve misplaced devices. A transcatheter retrieval system would be a major advance that would spare patients pain and provide a “safety net” that promotes the use of less invasive procedures. The efficacy of the retrieval system in removing many types of misplaced cardiovascular devices has been extensively demonstrated in Phase I using clinically relevant animal models. The goal of the current Phase II STTR proposal is to refine the design concept to the point of first-in-man applications