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Resorbable Antimicrobial Envelope to Prevent Infection of Implanted Cardiac DevicesAward last edited on: 2/17/2024
Sponsored Program
STTRAwarding Agency
NIH : NHLBITotal Award Amount
$2,195,642Award Phase
2Solicitation Topic Code
837Principal Investigator
Glenn BrunnerCompany Information
Phase I
Contract Number: 1R41HL137519-01A1Start Date: 9/1/2018 Completed: 8/31/2019
Phase I year
2018Phase I Amount
$200,000Public Health Relevance Statement:
Narrative Through the development of an antimicrobial envelope for cardiovascular implantable electronic devices (CIEDs), i.e., pacemakers and implantable cardioverter-defibrillators, Saranas will greatly reduce the incidence of infections associated with the implants. Reducing the number of CIED-related infections will also greatly reduce the cost-of-care for these patients, which increase by $50,000 per patient when an infection is acquired.
Project Terms:
Adoption; Antibiotics; Miscellaneous Antibiotic; Antibiotic Drugs; Antibiotic Agents; Combined Antibiotics; Antibiotic Drug Combinations; Antibiotic Combinations; Antifungal Agents; antifungals; anti-fungal drug; anti-fungal agents; anti-fungal; Therapeutic Fungicides; Antifungal Drug; Bacteria; Bacterial Infections; bacterial disease; Cardiovascular system; circulatory system; Heart Vascular; Cardiovascular Organ System; Cardiovascular Body System; Cardiovascular; Complication; Electronics; electronic device; Patient Care; Patient Care Delivery; Growth; ontogeny; Tissue Growth; Generalized Growth; Hydrolysis; In Vitro; Incidence; Infection; Minocycline; mortality; Patients; Printing; Production; Quality of life; QOL; Surgical Replantation; Replantation; Reimplantation; Research; Rifampin; Rimactane; Rifampicin; Rifadin; Benemycin; Risk; Genus staphylococcus; Staphylococcus; Staphylococcus aureus; Staph aureus; S.aureus; S. aureus; S aureus; Surveys; Survey Instrument; Technology; Testing; Time; Microbial Biofilms; biofilm; Catheters; polycaprolactone; Custom; Implantable Cardioverter-Defibrillators; Implantable Defibrillators; base; improved; incision; Otomy; Surgical incisions; Surface; Phase; Evaluation; Physical activity; cardiac rhythm; heart rhythm; antibacterial; anti-bacterial; Antibacterial Agents; Anti-Bacterial Agents; Exposure to; Shapes; Source; Operative Surgical Procedures; surgery; Surgical Procedure; Surgical Interventions; Surgical; Operative Procedures; Infection prevention; Prevent infection; cytotoxicity; Lytotoxicity; novel; member; Devices; Pacemakers; Stimulators, Electrical, Pace; Pace Stimulators; Property; methicillin resistant Staphylococcus aureus; methicillin-resistant S. aureus; Methicillin Resistant S. Aureus; Methicillin Resistant S Aureus; MRSA; Effectiveness; prevent; preventing; Address; Length; Retrieval; Filament; Small Business Innovation Research; SBIR; Small Business Innovation Research Grant; urinary; developmental; Development; anti-microbial peptide; antimicrobial peptide; cost; designing; design; resistant; Resistance; anti-microbial; antimicrobial; Implant; implantation; FDA approved; resistance strain; resistant strain; three dimensional printing; 3D printer; 3-D printer; 3-D print; 3D Print; care costs; cardiac implant; cardiodevice; cardiac device
Phase II
Contract Number: 2R44HL137519-02A1Start Date: 9/1/2018 Completed: 6/14/2024
Phase II year
2022(last award dollars: 2023)
Phase II Amount
$1,995,642Public Health Relevance Statement:
PROJECT NARRATIVE Infections related to the implantation of cardiovascular implantable electronic devices or CIEDs occur at high frequency (up to ca. 20% of the interventions) and are associated with a 2-fold increase in mortality rate. A solution that delivers a potent anti-infective locally that can eradicate resistant bacterial strains, fungal species, and is efficacious against biofilms is currently missing. N8 Medical is developing a bioresorbable polymeric envelope, that stabilizes the implanted pacemaker and eliminates a broad spectrum of pathogens (including resistant bacteria and fungi) causing CIED infections, through the application of ceragenins, a novel class of anti-infectives designed to mimic naturally occurring antimicrobial peptides.
Project Terms:
Anti-Infective Agents; Anti-Infective Drugs; Anti-Infectives; Anti-infective Preparation; AntiInfective Drugs; AntiInfectives; Antiinfective Agents; communicable disease control agent; Anti-Inflammatory Agents; Anti-Inflammatories; Anti-inflammatory; Antiinflammatories; Antiinflammatory Agents; antiinflammatory; Antibiotics; Antibiotic Agents; Antibiotic Drugs; Miscellaneous Antibiotic; Antifungal Agents; Antifungal Drug; Therapeutic Fungicides; anti-fungal; anti-fungal agents; anti-fungal drug; antifungals; Bacteria; Biological Assay; Assay; Bioassay; Biologic Assays; Candida; Monilia; Candida albicans; C albicans; C. albicans; C.albicans; Cardiovascular system; Cardiovascular; Cardiovascular Body System; Cardiovascular Organ System; Heart Vascular; circulatory system; Cephalosporins; Chlorhexidine; Coagulase; Electronics; electronic device; fungus; Gluconates; gluconic acid; Glycolates; glycolic acid; Goals; Growth; Generalized Growth; Tissue Growth; ontogeny; Health; In Vitro; Infection; Medical Device; Methods; Minocycline; Morbidity - disease rate; Morbidity; mortality; New Zealand; Patients; Permeability; Polymers; Production; Chrysemonas; Flavimonas; Pseudomonas; P aeruginosa; P. aeruginosa; Pseudomonas pyocyanea; Pseudomonas aeruginosa; Public Health; Domestic Rabbit; Rabbits; Rabbits Mammals; Oryctolagus cuniculus; Benemycin; Rifadin; Rifampicin; Rimactane; Rifampin; Risk; Safety; Staphylococcus; Genus staphylococcus; surgical site infection; Surgical Wound Infection; Testing; fabric; Textiles; Time; Vancomycin; Virus; poly(lactide); polylactide; Generations; Microbial Biofilms; biofilm; Antibiotic Resistance; Resistance to antibiotics; Resistant to antibiotics; antibiotic drug resistance; antibiotic resistant; Medical Care Costs; medical costs; bacterial resistance; Bacteria resistance; Bacteria resistant; Bacterial resistant; resistance to Bacteria; resistance to Bacterial; resistant to Bacteria; resistant to Bacterial; base; Defibrillators; Electric Shock Cardiac Stimulators; Stimulators, Electrical, Cardiac, Shock; Label; improved; Procedures; Surface; Acute; Chronic; Clinical; Phase; Medical; FDA Device Approval; Food and Drug Administration Device Approval; Antibacterial Agents; anti-bacterial; antibacterial; Anti-Bacterial Agents; Antibiotic Premedication; Antibiotic Prophylaxis; Industrial Product; infectious organism; Infectious Agent; Life; mechanical; Mechanics; Frequencies; Side; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Operative Surgical Procedures; Prevent infection; Infection prevention; biocompatibility; biomaterial compatibility; Lytotoxicity; cytotoxicity; membrane structure; Membrane; bioresorbable polymer; degradable polymer; biodegradable polymer; genotoxicity; microbial; Immunomodulation; immune modulation; immune regulation; immunologic reactivity control; immunomodulatory; immunoregulatory; immunoregulation; novel; Devices; Abscission; Extirpation; Removal; Surgical Removal; resection; Excision; Pace Stimulators; Pacemakers; Property; Intervention Strategies; interventional strategy; Intervention; epsilon-caprolactone; caprolactone; Skin; MRSA; Methicillin Resistant S Aureus; Methicillin Resistant S. Aureus; methicillin-resistant S. aureus; methicillin resistant Staphylococcus aureus; Effectiveness; preventing; prevent; Address; Dose; in vivo; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Preparation; Characteristics; safety study; preclinical study; pre-clinical study; antimicrobial peptide; anti-microbial peptide; cost; design; designing; cost effective; Resistance development; Resistant development; developing resistance; pathogen; Resistance; resistant; antimicrobial; anti-microbial; Implant; implantation; prototype; in vitro testing; product development; clinical practice; Sterilization; Secure; liver injury; Injury to Liver; hepatic damage; hepatic injury; liver damage; cardiac resynchronization therapy; systemic toxicity; Electrospinning; efficacy study; in vivo evaluation; in vivo testing; cardiac implant; cardiac device; cardiodevice; renal damage; damage to kidney; kidney damage; 2019-nCoV; 2019 novel corona virus; 2019 novel coronavirus; COVID-19 virus; COVID19 virus; CoV-2; CoV2; SARS corona virus 2; SARS-CO-V2; SARS-COVID-2; SARS-CoV-2; SARS-CoV2; SARS-associated corona virus 2; SARS-associated coronavirus 2; SARS-coronavirus-2; SARS-related corona virus 2; SARS-related coronavirus 2; SARSCoV2; Severe Acute Respiratory Coronavirus 2; Severe Acute Respiratory Distress Syndrome CoV 2; Severe Acute Respiratory Distress Syndrome Corona Virus 2; Severe Acute Respiratory Distress Syndrome Coronavirus 2; Severe Acute Respiratory Syndrome CoV 2; Severe Acute Respiratory Syndrome-associated coronavirus 2; Severe Acute Respiratory Syndrome-related coronavirus 2; Severe acute respiratory syndrome associated corona virus 2; Severe acute respiratory syndrome corona virus 2; Severe acute respiratory syndrome coronavirus 2; Severe acute respiratory syndrome related corona virus 2; Wuhan coronavirus; coronavirus disease 2019 virus; coronavirus disease-19 virus; hCoV19; nCoV2; infection rate; rate of infection; efficacy validation; validate efficacy