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Exchangeable Heart Valve for Tissue Engineering Applications

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
85822
Program Year/Program:
2007 / STTR
Agency Tracking Number:
HL088712
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
VALVEXCHANGE, INC.
c/o Ivan Vesely Greenwood Village, CO 80111-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2007
Title: Exchangeable Heart Valve for Tissue Engineering Applications
Agency: HHS
Contract: 1R41HL088712-01
Award Amount: $247,873.00
 

Abstract:

DESCRIPTION (provided by applicant): Each year, 70,000 patients in the United States need to have their diseased heart valves replaced. These patients can receive either bioprostheses made from animal tissues, or mechanical valves made from synthetic mater ials. Bioprostheses have few complications and are considered the ideal valve for most patients, but ultimately wear out last only about 12-15 years. Mechanical valves, on the other hand, because anticoagulation-related complications and used only if the p atient is too young to receive a bioprosthesis. The issue that drives the decision for a mechanical or bioprosthetic valve is the risk of reoperation - prosthetic valves are intended to be implanted once and should last the life of the patient. To address the problem of reoperative mortality, VXI has been developing an alternative approach - a rapidly exchangeable bioprosthetic valve. It is a two-component device, consisting of a permanent docking station that remains affixed to the patient's aorta, and a collapsible frame that supports the exchangeable leaflet set and plugs into the docking station. Exchange can be done quickly and safely, using minimally invasive tools or catheters, eliminating most of the risk of reoperation. With this technology, there is finally a tissue valve for mechanical valve patients. In an effort to broaden the use of the exchangeable valve technology, VXI is addressing an emerging technology - heart valve tissue engineering. Progress in this field has been hampered by the cost of the experimental model - the juvenile sheep that has a tissue-engineered valve implanted in the aortic position. At about 15,000 per experiment, scientists need to minimize the number of sheep and maximize the duration of the implant period. This appro ach limits the information that can be obtained from such experiments. If the animal experiments were to use an exchangeable valve, such as that developed by VXI, the animal need not be sacrificed. The valve can be explanted, examined, re-implanted, or exc hanged with a different tissue-engineered valve, without needing to sacrifice the animal. The objectives of this STTR proposal, therefore, are to (i) develop an exchangeable valve that can be fitted with leaflets composed biodegradable polymers typically u sed for tissue engineering, and (ii) evaluate the integrity of the tissue ingrowth into the exchangeable frame through tissue culture and mechanical testing. Hydrodynamic durability testing will also be done to (iii) ensure that there are no design flaws i n the complete valve assembly. Through this project, VXI will develop technologies that will serve the basic scientist engaged in tissue engineering. VXI will thus continue to advance the field of prosthetic valve technologies into new areas where innovati ve solutions for patients with heart valve disease are needed. Each year, 70,000 patients in the United States need to have their diseased heart valves replaced. These patients can receive valves made from animal tissues, or synthetic, man- made materials. Tissue valves have few complications and are considered the ideal valve for most patients, but ultimately wear out in about 12-15 years. Mechanical valves, on the other hand, cause blood clotting problems and the patients need to be on permanent blood thi nners, essentially living the life of a hemophiliac. The issue that drives the decision for a synthetic or tissue-based valve is the risk of reoperation. Although the first open- heart surgery is relatively safe, subsequent surgeries are far more risky. Ar tificial heart valves are intended to be implanted once and should last the life of the patient. To address the problem of reoperative complications, VXI has been developing an alternative approach - a rapidly exchangeable tissue valve. It is a two-compone nt device, consisting of a permanent docking station that remains in the patient, and a collapsible frame that supports the exchangeable tissue that ultim

Principal Investigator:

Ivan Vesely
3234819643
VESELY@VALVEXCHANGE.COM

Business Contact:


vesely@valvexchange.com
Small Business Information at Submission:

VALVEXCHANGE, INC.
VALVEXCHANGE, INC. c/o Ivan Vesely AURORA, CO 80045

EIN/Tax ID: 341858685
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Research Institution Information:
CHILDREN'S HOSPITAL LOS ANGELES
4650 SUNSET BLVD, Mailstop #84
LOS ANGELES, CA 90027-6062
RI Type: Domestic nonprofit research organization