Device for Rapid, Complete & Durable Occlusion of Wide-Neck Cerebral Aneurysms

ABSTRACT Metactive Medical is developing the Ballstent Microcatheteran innovative medical device for the endovascular embolic treatment of cerebral aneurysmswhich are a common cause of strokeThe key component of the device is the Ballstentan expandabledetachablegold metal balloon that can be pleated and folded at the distal end of a delivery microcatheteradvanced into an aneurysm sac over a guidewireexpandedpositioned to occlude the aneurysm neckand held in place by standard embolic coils that are delivered through the guidewire lumen of the device into the aneurysm sac behind the expanded BallstentThe device is then electrolytically detached from the delivery microcatheterThis combined Ballstent and coils approach enables the treatment of a wide range of aneurysm shapes and sizes since the Ballstent is sized to the diameter of the aneurysm neck while the coils are used fill in the remainder of the sacA pilot preclinical study with the Ballstent Microcatheter in a well acceptedlargewide neckvenous pouchterminal carotid artery aneurysm model in canines demonstrated immediate and complete aneurysm occlusion after treatmentwhich was maintained out todaysWhen compared to the Ballstent and coils treatmentthe use of coils alone requireddevices to fill the aneurysm sac and could not completely occlude the aneurysmeither acutely ordays laterWide neck sidewall aneurysms have been successfully treated with the Ballstent and coils approach as wellThe objective of the proposed Phase I program is to demonstrate that the treatment of wide neck bifurcation and sidewall aneurysms with Ballstent and coils is superior to coils onlyflow diverting stentsand intrasaccular flow diverters in acute and chronic aneurysm occlusionThe research also aims to demonstrate non inferiority of the Ballstent and coils approach on important safety measures including aneurysm rupture during treatment and thromboembolic eventsBased upon the success of Phase Ia Phase II program will complete verification andampvalidation of the final Ballstent Microcatheter design in several sizes and prepare for a first in human clinical trial PROJECT NARRATIVE Approximatelyof adults in the U Shave an abnormal outward bulge of an artery in the brain called a cerebral aneurysm that can rupture without warningoften leading to strokeMinimally invasive procedures have been developed to treat cerebral aneurysms using a catheter to pack the aneurysm sac with many small metal coilsblocking blood flow into the aneurysm and reducing the likelihood of aneurysm ruptureHoweverthesecoilingprocedures are long and complexhave substantial rates of complicationsand fail to fully treat the aneurysm aboutof the timeMetactive Medical is developing the Ballstent Microcathetera novel and innovative medical device for the treatment of cerebral aneurysm that can be used with coils to immediatelycompletelyand persistently occlude a wide range of cerebral aneurysm types and sizes