Over-the-Wire Device for Immediate and Complete Peripheral Artery Occlusion

ABSTRACT Metactive Medical is developing the Blockstent Microcatheteran innovative medical device for endovascular occlusion of peripheral arteries and veinsThe device uses an expandabledetachablegold metal balloon that can be delivered using a highly flexiblelow profileover thewire microcatheteraddressing an unmet medical need for a device that is easy to use and delivers immediatecompleteand lasting vessel occlusion in a wide variety of clinical indicationsIn a highly successful Phase I SBIR preclinical research program using canine artery occlusion modelsthe Blockstent Microcatheter allowed rapid and precise device placement and provided fastermore completeand more sustained occlusion than commercially availablemarket leading coils and vascular plugsIn one arm of the studythe axillary arteries of four dogs were treated bilaterally using amm Blockstent on one side and amm AmplatzerVascular Plug IIAVPon the other sideAcutelyall four Blockstent treatments resulted in immediate and complete vessel occlusion by angiographywhile all four AVPtreatments requiredminutes to achieve vessel occlusionAtdaysall four Blockstent treatments demonstratedocclusion whereas all four AVPtreatments showed rapiddirect flow through deviceIn a second arm of the studythe internal thoracic arteries of four dogs were treated bilaterally using amm Blockstent on one side and amm Amplatzer Vascular Plug IVAVPon the other sideAcutelyall four Blockstent treatments resulted in immediate and complete vessel occlusion by angiographywhile all four AVPtreatments requiredminutes to achieve vessel occlusionAtdaysthree of four Blockstent treatments demonstratedocclusion whereas all four AVPtreatments showed rapiddirect flow through deviceIn an acute study of eight dogs with induced right carotid artery bleedingthree of fourmm Blockstent treatments demonstrated immediate cessation of flow and bleeding after placement of a single devicewith a fourth showing a minimal amount of residual bleeding that was stopped by placing a second deviceAll four of themm AVPtreatments showed blood flow through the device and rapid bleeding after device placementand three of four treatments showed blood flow through the device and bleeding at the end of the five minute observation periodThe proposed Phase II SBIR program would fund the development of a quality management system at Metactivein vitro and in vivo design verification and validation studiesand US and EU regulatory filings to support the market launch of the Blockstent Microcatheter PROJECT NARRATIVE Aboutpeople worldwide receive treatment each year to stop the flow of blood in selected arteries and veins using catheter delivered devicesincluding patients with life threatening bleedingcancerand blood vessel diseases such as aneurysmsarteriovenous fistulasand arteriovenous malformationsThe devices currently used for these procedures include coiled wires and wire mesh plugsThese devices cause blood to clotleading to blood vessel blockageAlthough preferable to open surgerythe devices can be difficult to place preciselyoften take substantial time to work completelyand do not always provide long term vessel closureall of which reduces their effectivenessMetactive MedicalIncis developing the Blockstent Microcatheteran innovative medical device that can be placed quickly and precisely and results in immediatecompleteand permanent blockage of arteries and veins