Multi-Functional Guidewire for Peripheral Vasculature

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$199,756.00
Award Year:
2013
Program:
SBIR
Phase:
Phase I
Contract:
1R43HL117424-01
Award Id:
n/a
Agency Tracking Number:
R43HL117424
Solicitation Year:
2013
Solicitation Topic Code:
NHLBI
Solicitation Number:
PA12-088
Small Business Information
251 N. Illinois Street, INDIANAPOLIS, IN, 46204-
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
804419740
Principal Investigator:
WILLIAM COMBS
(317) 377-0300
wcombs@flowco-inc.com
Business Contact:
JENNIFER RHODES
(317) 377-0300
jrhodes@3dtholdings.com
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): Over 8 million Americans have peripheral vascular disease (PAD). Percutaneous transluminal artery (PTA) treatment of severe PAD involves the use of balloons and stents, but delivery of these therapies is often suboptimal due to inaccuracies in angiographic assessment of vessel size or a lack of proper functional vessel assessment. Additional tools aid clinicians in accurately determining vessel size and function, but these are often unused because of the added time, cost, training, and interpretation required. Guidewires are used in every interventional procedure, so the ability of a guidewire to provide not only a stable platform for therapy delivery, but also a diagnostic tool for vessel structure and function would bevaluable. We have developed a fully functional 0.035 LumenRECON (LR) guidewire that has the same mechanical properties as a standard Wholey workhorse guidewire, but also uses electrical impedance technology to assess vessel lumen size and stenosis pressure drop. Thus, the guidewire provides a 3-in-1 functionality (i.e. one workhorse guidewire that acts as a platform for therapy delivery, vessel sizing, and stenosis pressure drop assessment). In this Phase I proposal, we will perform a pre-clinical study tovalidate the functionality of our 0.035 LumenRECON (LR) guidewire as a standard workhorse guidewire for vessel navigation and an accurate diagnostic tool for luminal sizing and pressure drop measurements in large animals. To accomplish the Phase I objectives, the safety, along with accuracy and repeatability of the sizing (specific aim #1) and pressure drop (specific aim #2) measurements will be assessed in domestic swine and measured against current clinically used tools, such as intravascular ultrasound(IVUS), quantitative angiography (QA), and pressure wires. This proposal addresses the significant and growing national epidemic of PAD and addresses an area that is growing, yet often overlooked. Successful completion of the proposed Aims will allow us to translate our research findings into a device that could drastically improve the treatment of PAD. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Determination of arterial lumen size and function is critical, but often not assessed adequately during peripheral interventions. The objective of this Phase I SBIR is to validate a novel 0.035 workhorse-type guidewire that provides 3 in 1 functionality as a standard navigational system, as well as a tool for vessel sizing and stenosis pressure drop assessment.

* information listed above is at the time of submission.

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