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Device for Rapid, Complete & Durable Occlusion of Wide-Neck Cerebral Aneurysms
Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43NS092184-01A1
Agency Tracking Number: R43NS092184
Amount:
$220,775.00
Phase:
Phase I
Program:
SBIR
Solicitation Topic Code:
106
Solicitation Number:
PA16-302
Timeline
Solicitation Year:
2016
Award Year:
2018
Award Start Date (Proposal Award Date):
2018-09-15
Award End Date (Contract End Date):
2019-08-31
Small Business Information
10900 S CLAY BLAIR BLVD, STE 200, Olathe, KS, 66061-1306
DUNS:
079301767
HUBZone Owned:
N
Woman Owned:
N
Socially and Economically Disadvantaged:
N
Principal Investigator
Name: F FRANANO
Phone: (816) 550-9177
Email: nfranano@metactivemedical.com
Phone: (816) 550-9177
Email: nfranano@metactivemedical.com
Business Contact
Name: F. FRANANO
Phone: (913) 440-4439
Email: nfranano@metactivemedical.com
Phone: (913) 440-4439
Email: nfranano@metactivemedical.com
Research Institution
N/A
Abstract
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 * Information listed above is at the time of submission. *