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A 3D Printed Resorbable Antimicrobial Envelope to Prevent Infection of Implanted Cardiac Devices

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL137519-01A1
Agency Tracking Number: R41HL137519
Amount: $200,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA17-303
Timeline
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-01
Award End Date (Contract End Date): 2019-08-31
Small Business Information
807 KINNEAR ROAD, SUITE 100
Columbus, OH 43212-1489
United States
DUNS: 063409728
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 GLENN BRUNNER
 (614) 946-4178
 gbrunner@n8medical.com
Business Contact
 KENNETH LEACHMAN
Phone: (877) 686-3338
Email: kleachman@n8medical.com
Research Institution
 SOUTHWEST RESEARCH INSTITUTE
 
6220 CULEBRA RD
SAN ANTONIO, TX 78238-5166
United States

 Federally funded R&D center (FFRDC)
Abstract

ABSTRACT
Infection is a serious and potentially fatal complication of surgery to deliver cardiovascular implantable electronic
devicesCIEDsi epacemakers and implantable cardioverter defibrillatorsUntreated device related
infection is associated with mortality rates as high asCurrentlyonly one antibiotic impregnated mesh has
been FDA approved for placement in surgical incisions to reduce infections associated with the implantation of
CIEDsHoweverstaphylococci bacteriawhich are commonly found in CIED infectionshave well documented
resistance to the combination antibiotics used in the meshMoreoverthe antibacterials can promote the growth
of fungiia source of rarebut highly fatal CIED infectionsThe use of the currentbulky implantable mesh
envelops increase surgical pocket sizewhich can restrict a patientandapos s physical activities and increase the chance
of infectionAnd the meshitselfcontributes to the space constraints of the surgical pocketwhich reduces the
size of the CEIDs that can be accommodatedyet the vast majority of patients would prefer larger devices that
last longerIncreasing the length of time between device retrievals and reimplantations would improve the quality
of life for patients while decreasing the risk of infections associated with surgeryThe objective of this Phase I
SBIR proposal is to useD printing to fabricate a biodegradable polycaprolactonePCLbased antimicrobial
envelopeto be fitted outside of cardiac rhythm deviceswhich will prevent infections after surgical implantationThe hypothesis is that a slow degradationhydrolysisof the PCL envelope will gradually release a novel
antimicrobial compoundCSAa cerageninfor antimicrobial and anti fungal activityCSAis a synthetic
non peptide compoundwith no pre existing pool of resistancethat mimics the activity of the bodyandapos s endogenous
antimicrobial peptidesThe proposed device will be the first to prevent fungal colonization of cardiac deviceswhile still providing superior and longer lasting inhibition of bacterial growthMoreoverthe customization
allowed byD printing will also minimize surgical pocket space constraintsTo advance this antibiotic mesh
technologya PCL filament forD printing applications will be developed that is loaded with the antimicrobialCSAThe elution profiles of the filament will be evaluated and the in vitro efficacy of CSAwill be testedNextenvelopes composed of antibiotic loaded filament will be fabricatedD printingfollowing a design that
accommodates a pacemakerAndfinallythe antimicrobial and anti fungal properties of the PCL envelope will
be demonstrated and its cytotoxicity evaluatedIt is expected that incorporation of CSAinto aD printed
biodegradable mesh will either prevent or significantly reduce biofilm formation on CIEDs when exposed to daily
inocula of Staphylococcus aureusMRSAfor at leastdaysThis project will pioneer the melding of a novel
antimicrobial with aD printingPCL filamentthereby enabling the production of custom fit envelops for
pacemakers and facilitating trouble free surgical implantationNarrative
Through the development of an antimicrobial envelope for cardiovascular implantable electronic devicesCIEDsi epacemakers and implantable cardioverter defibrillatorsSaranas will greatly reduce the incidence
of infections associated with the implantsReducing the number of CIED related infections will also greatly
reduce the cost of care for these patientswhich increase by $per patient when an infection is acquired

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

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