Artio Medical, Inc — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant Approximately peripheral artery embolization procedures are performed annually in the U S for a variety of clinical indications including stopping life threatening bleeding reducing blood flow to cancerous tumors and diverting blood away from arterial aneurysms arteriovenous fistulas and other vascular malformations Most of these procedures involve the implantation of wire coils or wire mesh vascular plugs to stimulate the formation of thrombus resulting in blood vessel occlusion These devices are difficult to place accurately require substantial time and effort to achieve complete occlusion and can be susceptible to vessel recanalization all of which can reduce the overall effectiveness of the treatment Metactive Medical Inc is developing the Blockstent Microcatheter tm an innovative embolic medical device that is easy to use can be placed with a high degree of precision and results in immediate complete and sustained blood vessel occlusion Based upon highly successful pilot nonclinical studies Metactive believes the Blockstent Microcatheter has the potential to enable more precise device placement faster more complete and more durable blood vessel occlusion and fewer complications relative to currently available devices such as coils and vascular plugs The objective of this proposed Phase I program is to compare the performance of the Blockstent coils and vascular plugs in canine models of vascular occlusion A planned Phase II program includes finalizing the Blockstent design in a range of sizes performing design for manufacturing activities completing design verification andamp validation developing a quality management system and launching first commercial sales of the device PUBLIC HEALTH RELEVANCE About people in the U S receive treatment each year to block the flow of blood in arteries and veins using catheter delivered devices including patients with life threatening bleeding cancer and blood vessel diseases such as aneurysms arteriovenous fistulas and arteriovenous malformations The devices currently used for these procedures include coiled wires and wire mesh plugs These devices cause blood to clot leading to blood vessel blockage Although preferable to open surgery these devices can be difficult to place with precision and often take substantial time to work completely and treated vessels can reopen later all of which reduces their overall effectiveness Metactive Medical Inc is developing the Blockstent Microcatheter tm an innovative medical device that can be placed quickly and precisely and results in immediate and permanent blockage of blood vessels