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A Self-Monitoring Artificial Vascular Graft

Award Number: R44HL071359
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2002
PERIOD OF PERFORMANCE END DATE: 03/31/2015

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A Self-Monitoring Artificial Vascular Graft - DESCRIPTION (provided by applicant): Several hundred thousand people in the USA each year require artificial blood vessels, "grafts", to be placed in their legs because of failing circulation. Sixty thousand of these patients require artificial prosthetic grafts. Unfortunately, many of the artificial grafts become occluded in just a few years (almost 40 % fail within a year), leading to leg amputation. The overall goal of this program is to improve the lives of people requiring artificial vascular grafts by decreasing the need for amputation. In addition to improving quality of life, there will be a substantial reduction in cost to the medical system. In earlier phases of this SBIR program, a "smart graft" was successfully developed and tested; a smart graft not only carries blood, but also measures the blood flow and, by means of an implanted transceiver, wirelessly transmits these measurements to a base station outside the body. The base station alerts a physician to an impending graft occlusion if the smart graft's measurements show impending occlusion. The purpose of this Renewal proposal is to bring the development of the smart graft to the point of readiness for human trials, the last step before commercialization To do so, the smart graft will be enhanced by adding pressure measuring to flow measuring, improving the validity of its measurements. (It also allows doubling the battery-life). The improved smart grafts will be implanted in dogs along with a controllable stenosis, already developed for this program. By monitoring the flow and pressure in the graft as the stenosis is increased causing the graft to occlude, the changes in flow and pressure that show impending graft failure can be determined. These signs of imminent graft failure will be validated in the final part of the program in which smart graft life in one leg of a dog will be compared with the survival of a conventional graft in the other leg. The trial is designed to show that smart grafts will significantly increase graft life and therefore reduce amputations. In addition, the trial will demonstrate the safety of the smart graft, i.e. its biocompatibility and lack of side effects. With proof of graft efficacy and safety, human trials of smart grafts will be able to begin. Smart grafts will lead to far fewer amputations, both improving care and also reducing costs. PUBLIC HEALTH RELEVANCE: The artificial grafts needed to correct poor circulation in the legs frequently become occluded, which leads to amputation of the legs. We have developed a new graft that alerts the physician that the graft is occluding to allow timely intervention, and thus prevents graft failure. Reducing the number of amputations both improves quality of life and reduces costs.


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: 2014 ( Subtotal = $0 )
2014	2012	DVX LLC	PO BOX 368	KINGSTON	NJ	08528	SOMERSET	USA	Cardiovascular Diseases Research	000	6	3/24/2014	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2012 ( Subtotal = $448,481 )
2012	2012	DVX LLC	31 Airpark Rd	Princeton	NJ	08540	MERCER	USA	Cardiovascular Diseases Research	000	6	8/16/2012	NON-COMPETING CONTINUATION	$448,481
														Subtotal = $448,481

Issue Date FY: 2011 ( Subtotal = $468,372 )
2011	2011	DVX LLC	31 Airpark Rd	Princeton	NJ	08540	MERCER	USA	Cardiovascular Diseases Research	001	5	3/30/2011	NON-COMPETING CONTINUATION	$448,149
2011	2010	DVX LLC	31 Airpark Rd	Princeton	NJ	08540	MERCER	USA	Cardiovascular Diseases Research	000	4	1/11/2011	COMPETING CONTINUATION	$20,223
														Subtotal = $468,372

Issue Date FY: 2010 ( Subtotal = $672,879 )
2010	2010	DVX LLC	31 Airpark Rd	Princeton	NJ	08540	MERCER	USA	Cardiovascular Diseases Research	000	4	4/20/2010	COMPETING CONTINUATION	$672,879
														Subtotal = $672,879

Issue Date FY: 2005 ( Subtotal = $430,469 )
2005	2005	DVX LLC	PO BOX 368	KINGSTON	NJ	08528	SOMERSET	USA	Cardiovascular Diseases Research	000	3	9/9/2005	NON-COMPETING CONTINUATION	$430,469
														Subtotal = $430,469

Issue Date FY: 2004 ( Subtotal = $688,565 )
2004	2004	DVX LLC	PO BOX 368	KINGSTON	NJ	08528	SOMERSET	USA	Cardiovascular Diseases Research	000	2	8/31/2004	COMPETING CONTINUATION	$688,565
														Subtotal = $688,565

Grand Total All Awards = $2,708,766

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A Self-Monitoring Artificial Vascular Graft

Award Number: R44HL071359

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2002

PERIOD OF PERFORMANCE END DATE: 03/31/2015

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