Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Infection resistant surface for ventricular assist device (VAD) transcutaneous dr

Award Number: R44HL117480
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/16/2013
PERIOD OF PERFORMANCE END DATE: 07/31/2016

Group Awards By:

View Award Description

Infection resistant surface for ventricular assist device (VAD) transcutaneous dr - DESCRIPTION (provided by applicant): Infection is a common and frequently very serious complication associated with medical implants. Man-made materials, including those used to fabricate ventricular assist devices (VADs), compromise the body's ability to fight infection in tw ways. First, by breaching skin with transcutaneous cannulae and drivelines, and second, by eliciting a foreign body reaction which results in scarring near the implant surface that creates an environment where bacteria can thrive outside the reach of the body's immune system. Currently available infection resistant materials typically rely on the release of antimicrobial substances. Though effective over the short-term, the released drugs can compromise normal healing and exacerbate the problem of isolating the implant surface from the body's immune defenses. Ension proposes development of an infection resistant surface designed to promote normal healing for application to the transcutaneous drivelines of ventricular assist devices. The proposed surface will incorporate a three-pronged approach to infection resistance; a low adhesion surface designed to prevent or hinder the attachment of microbes, controlled release of antimicrobial agents, and a natural collagen surface that promotes tissue integration. The innovation of the surface lies in going beyond the partial solution of acute antimicrobial release (such as the silver-impregnated gauze typically used in VAD transcutaneous driveline applications) to an engineered surface that also promotes optimal healing response of the adjacent tissue. The normal healing response near the surface generates tissue devoid of scarring and chronic inflammation, assuring a normal immune response and thus improving long-term infection resistance. Preliminary in vitro testing using prototype surfaces demonstrated that the proposed surface facilitates fibroblast adhesion (a part of normal healing), resists attachment of bacteria, and avoids causing toxicity that would hinder normal healing. The proposed Fast Track project will refine the most promising prototype surface and apply it to polyurethane substrate material (Phase I Specific Aim 1), fabricate and test implants treated with the optimized surface for biocompatibility in mice (Phase I Specific Aims 2 and 3), and perform detailed in vivo evaluation of infection resistance in pigs (Phase II). The Phase II in vivo testing will include groups of pigs implanted with bacterial challenge at implant, with periodic bacterial challenges following implant, and "unchallenged" controls (Phase II Specific Aim 2). Fluorescence labeling and confocal microscopy will be used to determine the types and numbers of cells at or near the implant surface and their spatial distribution (Phase II Specific Aim 3). These methods also allow detection of fibrin and collagen in the same tissue samples. The data obtained will be compared both to controls and to established data observed during normal healing. The surface is expected to show improvement over untreated controls with respect to healing response, bacterial adhesion, local infection and systemic signs of infection. Successful completion of the Fast Track project plan will result in a surface ready for qualification testing, regulatory approval, and subsequent commercialization.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2014	ENSION INC	240 WILLIAM PITT WAY	PITTSBURGH	PA	15238	ALLEGHENY	USA	Cardiovascular Diseases Research	000	2	12/20/2016	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $880,733 )
2014	2014	ENSION, INC	240 WILLIAM PITT WAY	PITTSBURGH	PA	15238	ALLEGHENY	USA	Cardiovascular Diseases Research	001	2	7/18/2014	EXTENSION WITH OR WITHOUT FUNDS	$880,733
2014	2013	ENSION, INC	240 WILLIAM PITT WAY	PITTSBURGH	PA	15238	ALLEGHENY	USA	Cardiovascular Diseases Research	000	1	11/20/2013	NEW	$0
														Subtotal = $880,733

Issue Date FY: 2013 ( Subtotal = $391,529 )
2013	2013	ENSION, INC	240 WILLIAM PITT WAY	PITTSBURGH	PA	15238	ALLEGHENY	USA	Cardiovascular Diseases Research	000	1	9/15/2013	NEW	$391,529
2013	2013	ENSION, INC	240 WILLIAM PITT WAY	PITTSBURGH	PA	15238	ALLEGHENY	USA	Cardiovascular Diseases Research	001	1	11/20/2013	NEW	$0
														Subtotal = $391,529

Grand Total All Awards = $1,272,262

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Infection resistant surface for ventricular assist device (VAD) transcutaneous dr

Award Number: R44HL117480

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/16/2013

PERIOD OF PERFORMANCE END DATE: 07/31/2016

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer