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A universal TET system for implanted life support systems

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL078499-02A1
Agency Tracking Number: HL078499
Amount: $1,237,200.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Timeline
Solicitation Year: 2008
Award Year: 2008
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
ABIOMED, INC. 22 CHERRY HILL DRIVE
DANVERS, MA 01923
United States
DUNS: 050636737
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 () -
Business Contact
Phone: (978) 777-5410
Email: rstewart@abiomed.com
Research Institution
N/A
Abstract

DESCRIPTION (provided by applicant): The ultimate objective of this proposed program is the commercialization of a universal transcutaneous energy transfer (TET) system with a high performance implantable battery. This integrated power system will be adapt
able to a host of next generation fully implantable mechanical circulatory support (MCS) systems. To date, fully implantable systems (i.e. the combination of an implantable electric MCS system and a TET system allowing electrical power transfer across the
intact skin) appear to be the most promising approach to eliminating the risk of exit site infection altogether. Most MCS systems in clinical use today require either cannulae (if the blood pump is extracorporeal) or drivelines (if the blood pump is intrac
orporeal) to cross the patient's skin. With such percutaneous designs, infection at the exit site is a primary cause of morbidity and mortality during long term management of patients. Under Phase I of the program, the feasibility of the digital, fault-tol
erant TET system was demonstrated. Abiomed's analog TET system for the FDA-approved AbioCor Implantable Replacement Heart was redesigned using digital circuits, enhanced for fault-tolerance, and reconfigured for improved spatial coupling. Digital versions
of both the implanted TET (iTET) and external TET (eTET) electronics were prototyped and tested. A preferred TET configuration was then selected as the basis for the Phase II program. Under the proposed Phase II program, Abiomed's key innovation will be a
universal TET system, integrated with an implantable battery pack having very high capacity (60 Wh) and cycle life (gt1,000 charge/discharge cycles). A digital, fault-tolerant TET architecture and novel solid state lithium battery chemistry will be employe
d. Sold as an original equipment manufacturer (OEM) product, this flexible power system will bring the survival and quality of life benefits of fully implantable technology to an increased number of patients through a host of MCS systems. Under the continu
ed program, the design and feasibility testing of the universal TET system will be completed. Based on the success of our Phase II program, private funding would enable further development and design qualification activities in anticipation of commercial l
aunch of the universal TET product. Abiomed would partner with at least one other company to integrate the universal TET system into the partner's MCS system; transfer the universal TET system to manufacturing and produce clinical units for the partner; an
d provide technical support while the partner completes system-level safety and compliance testing, conducts clinical trials, and seeks regulatory approval for its MCS system. PUBLIC HEALTH NARRATIVE: Existing schemes for powering implantable mechanical ci
rculatory support (MCS) systems pose the risk of infection at cable exit sites, particularly during long term use. Transcutaneous energy transmission (TET) systems reduce this risk by delivering electrical power across the intact skin, but this technology
has not yet come into widespread use. The universal TET system and high performance implantable battery proposed in this research would offer a general purpose, highly reliable means of powering a host of next generation MCSSs. This original equipment manu
facturer (OEM) product would therefore both improve patient quality-of-life and enhance commercialization of MCS technology for long term applications.

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

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