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Preclinical Testing of a Novel Flow Diverting Stent for Treating Intracranial Aneurysms

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42NS074576-03
Agency Tracking Number: R42NS074576
Amount: $2,949,208.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 101
Solicitation Number: PA14-072
Timeline
Solicitation Year: 2014
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-02-15
Award End Date (Contract End Date): 2020-01-31
Small Business Information
466 FOOTHILL BLVD
La Canada Flintridge, CA 91011-3518
United States
DUNS: 024185420
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 COLIN KEALEY
 (323) 491-0894
 ckealey@mednet.ucla.edu
Business Contact
 LEON EKCHIAN
Phone: (310) 479-3100
Email: lekchian@neurosigma.com
Research Institution
 MAYO CLINIC ROCHESTER
 
200 1ST ST SW
ROCHESTER, MN 55905-0001
United States

 Domestic nonprofit research organization
Abstract

DESCRIPTIONprovided by applicantThe purpose of this project is to develop an improvedminimally invasive treatment for intracranial aneurysmsIntracranial aneurysms are spherical outpouchings of blood vessels in the head that result from weakness in the vessel wallUnruptured aneurysms are present in approximatelyof the general populationand rupture can be devastating with a high morbidity and mortalityIn recent years a new type of minimallyinvasive endovascular device to treat aneurysms has been introduced to the marketThese devicesknown as flow diverting stentsare composed of a tubular metal mesh and are placed in the parent artery to cover the neck of the aneurysm being treatedThe small pores in the mesh prevent blood from entering the aneurysmwhich causes blood trapped inside the aneurysm to become stagnant and clotThe aneurysm then undergoes a process of healing with the stent acting as a scaffold for reconstruction of the parent arteryDespite their successfirst generation flow diverters suffer from a number of limitations such as delayed aneurysm occlusionoften on the order of monthsand the need for multiple devices per patient to achieve complete occlusionIn as many asof patients complete occlusion is never achievedNeuroSigma s next generation flow diverter is based on Thin Film NitinolTFNtechnologyTFN is an advanced biomaterial fabricated on silicon wafers that overcomes many of the limitations associated with first generation flow divertersResults from animal studies suggest that the TFN flow diverter gives superior rates of aneurysm occlusion and faster parent artery repair than first generation devicesThe purpose of this project is to build upon these intriguing findings an develop a "rapid occlusion" flow diverterwhere placement of a single device results in speedydefinitive aneurysm repairAt the completion of this project the TFN flow diverter will be ready t begin firstin human studies as an improved treatment for the millions who suffer from intracranial aneurysms worldwide

* Information listed above is at the time of submission. *

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