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Venous Window Access Catheter For Hemodialysis

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
89006
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
CA139608
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
VITAL ACCESS, INC.
VITAL ACCESS, INC. 2302 PRESIDENTS DR, STE C SALT LAKE CITY, UT 84120-2340
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: Yes
 
Phase 2
Fiscal Year: 2009
Title: Venous Window Access Catheter For Hemodialysis
Agency: HHS
Contract: 4R44CA139608-02
Award Amount: $1,057,200.00
 

Abstract:

DESCRIPTION (provided by applicant): A novel, venous window access device (VWAD), anastomotic tool, and minimally invasive, image-guided surgical procedure to provide hemodialysis for patients suffering from End Stage Renal Disease (ESRD) have undergone ea rly stage development. The device can serve as a destination therapy or as a bridge device to provide temporary access during maturation of an arteriovenous (AV) fistula. The device consists of a percutaneous access conduit, anastomosed to a central vein , i.e. the right jugular vein, that serves as an percutaneous access port. Dialysis is performed (three times weekly) by advancing a dual lumen, disposable catheter down the access conduit and into the vein. When not in use, the percutaneous access conduit is back filled with anti-microbial solution and is completely isolated from the circulation by an occluding obturator. The disposable obturator is removed and replaced between dialysis sessions. The technology has several advantages: 1) Anastomosis of the access conduit to the outside of the vein allows the device to reside outside the continuous blood path in the vein, as opposed to conventional, indwelling dialysis catheters. 2) The outdwelling configuration of this device will reduce thrombus, stenosi s of the healthy vein, and potential for blood communication with the sinus tract. Preliminary in vitro and in vivo studies have identified procedural and design improvements required to reduce this system to clinical practice. The objective of this SBIR f ast track proposal is to complete the clinical configuration design, build prototypes, perform in vitro performance and safety testing, and verify in vivo performance with chronic implants in sheep. This project will allow completion of development of a cl inical configuration and prepare for Phase II clinical testing and final regulatory submission leading to commercialization of this concept.

Principal Investigator:

Steven W. Johnson

Business Contact:


sjohnson@vital-access.com
Small Business Information at Submission:

VITAL ACCESS, INC.
VITAL ACCESS, INC. 2302 PRESIDENTS DR, STE C SALT LAKE CITY, UT 84120

EIN/Tax ID: 120541090
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No