MECHANICAL AUXILIARY VENTRICLE

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 3246
Amount: $369,000.00
Phase: Phase II
Program: SBIR
Awards Year: 1987
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
70 Gallogly Road, Pontiac, MI, 48055
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Adrian Kantrowitz
 Principal Investigator
 (313) 493-6440
Business Contact
Phone: () -
Research Institution
N/A
Abstract
THIS PROJECT ADVANCES THE DEVELOPMENT OF A MECHANICAL AUXILIARY VENTRICLE (MAV) FOR THE TREATMENT OF INTRACTABLE CHRONIC LEFT VENTRICULAR FAILURE. THE LONG-TERM OBJECTIVE IS TO QUALIFY THE MAV SYSTEM FOR FDA APPROVAL FOR THE SYSTEM'S COMPONENTS ARE AN AVALVULAR PUMPING CHAMBER IMPLANTED IN THE DESCENDING THORACIC AORTA, AN EXTERNAL PNEUMATIC POWER SOURCE, AND A PERCUTANEOUS ACCESS DEVICE (PAD). CLINICAL TRIAL OF AN EARLIER VERSION OF THE MAV IN 3 PATIENTS CONFIRMED SUBSTANTIAL HEMODYNAMIC EFFICACY FOR PERIODS UP TO 96 DAYS, BUT SHOWED THE PAD TO BE FAILURE-PRONE. IN LATER LABORATORY STUDIES IT WAS FOUND THAT THE BLOOD PUMP'S CONSTITUENT LAYERS COULD HARBOR CELLULAR DEBRIS, FORMING A NIDUS OF INFECTION. SINCE THEN, RESEARCH AND DEVELOPMENT OF A NEW PAD HAVE RESULTED IN PROMISE OF A STABLE DEVICE, AND A NEW SINGLE-LAYER IMPROVED DESIGN OF THE PUMPING CHAMBER HAS ALSO BEEN EVOLVED. THE OBJECTIVE OF PHASE I STUDIES IS TO CONFIRM THAT THE REDESIGNED PUMPING CHAMBER IS READY FOR LONG-TERM IN VIVO EVALUATION. THE MAV, IMPLANTED IN 5 CALVES, WILL BE PUMPED ON A 6-HOUR-ON, 6-HOUR-OFF SCHEDULE FOR 6 WEEKS. THIS WILL PROVIDE A TEST OF THE ADEQUACY OF THE AORTIC SUTURE LINE. THROUGHOUT THE STUDY, CLOTTING PARAMETERS WILL BE SCREENED. THE ANIMALS WILL THEN BE SACRIFICED SO THAT THE MAV AND ADJACENT TISSUES CAN BE EXAMINED AND A CAREFUL SEARCH FOR EMBOLI

* Information listed above is at the time of submission. *

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