21MedTech, LLC is developing the ARRAYTM antibiotic-loaded envelope to address the need for novel methods to tackle rising rates of infections associated with cardiovascular implantable electronic devices (CIEDs). There were 1.5 million CIEDs implanted in 2011 and that number continues to grow. Between 1% and 4% of implantations result in infection, which have potential for severe morbidity and mortality outcomes. The mortality rate from CIED associated pocket infections can be as high as 66% if the device is not removed and up to 18% with device removal and antibiotic therapy. To address the need for additional methods to reduce or prevent these infections, 21MedTech is developing the ARRAY envelope for longer-term protection. The ARRAY envelope employs a novel bioresorbable polymer film that facilitates the controlled release of rifampin and minocycline locally following surgical implantation of a CIED. The envelope is highly tunable, enabling control over drug release and degradation time, and has been shown to be highly biocompatible in vivo. Prior to this Direct to Phase II proposal, 21MedTech has demonstrated safety and efficacy of the envelope material in vitro and in vivo and has demonstrated feasibility with controlled release of rifampin and minocycline over 28 days. 21MedTech has also shown improved drug release profiles over the commercially available TYRXTM envelope in vitro, which exhibits a burst release (>90%) in the first 24 hours. The goals of this proposal will be to optimize release of antibiotics from the envelope, assess safety and efficacy, and to determine the effective dose in a well-defined animal model. Success with these goals will advance the ARRAY envelope towards FDA clearance. Commercialization of the ARRAY envelope will improve CIED surgical outcomes and improve patient quality of life by reducing CIED associated infections.
Public Health Relevance Statement: PROJECT NARRATIVE There is an urgent need for the development of innovative methods to manage infections associated with cardiovascular implantable electronic devices (CIEDs). Within this project, 21MedTech is developing a novel bioresorbable envelope that releases a controlled amount of antibiotics over time to reduce CIED associated infections. Success with these goals and FDA clearance will enable release of an innovative product that will improve morbidity and mortality outcomes in patients with CIEDs.
Project Terms: aminoacid; Amino Acids; Animals; Antibiotic Agents; Antibiotic Drugs; Miscellaneous Antibiotic; Antibiotics; Bacteria; Cardiovascular system; Cardiovascular; Cardiovascular Body System; Cardiovascular Organ System; Heart Vascular; circulatory system; Cefazolin; comorbidity; co-morbid; co-morbidity; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Electronics; electronic; electronic device; Esters; Exhibits; Goals; Gram-Negative Bacteria; Cyclic GMP; Guanosine Cyclic Monophosphate; cGMP; Hernia; Hospitalization; Hospital Admission; implantable device; biomedical implant; implant device; indwelling device; In Vitro; Incidence; Infection; Kinetics; Marketing; Methods; Minocycline; Morbidity - disease rate; Morbidity; mortality; Patients; Drug Kinetics; Pharmacokinetics; Polyesters; Polymers; polymer; polymeric; Postoperative Period; Post-Operative; Postoperative; Quality of life; QOL; Oryctolagus cuniculus; Domestic Rabbit; Rabbits; Rabbits Mammals; Rattus; Common Rat Strains; Rat; Rats Mammals; Surgical Replantation; Reimplantation; Replantation; Rifampin; Benemycin; Rifadin; Rifampicin; Rimactane; Risk; Safety; Time; Titanium; Ti element; Urea; Carbamide; Elaqua XX; Urea Carbamide; Ureaphil; Film; dosage; Label; improved; Procedures; Residual; Residual state; Phase; Series; Hospitalization cost; Hospital Costs; soft tissue; Licensing; non-narcotic analgesic; non-opiate analgesic; non-opioid; non-opioid therapeutics; nonnarcotic analgesics; nonopiate analgesic; nonopioid; nonopioid analgesics; non-opioid analgesic; Antibiotic Therapy; Antibiotic Treatment; bacterial disease treatment; bacterial infectious disease treatment; Hour; prophylactic; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Infection prevention; Prevent infection; Colony-forming units; biomaterial compatibility; biocompatibility; copolymer; stoichiometry; success; biodegradable polymer; bioresorbable polymer; degradable polymer; Animal Model; Animal Models and Related Studies; model of animal; microbial; novel; Devices; Device Removal; Pharmacodynamics; controlled release; Modeling; Skin; Inflammatory Response; Thickness; Thick; preventing; prevent; Address; Dose; Data; in vivo; Preparation; preparations; Development; developmental; designing; design; Outcome; pathogen; Population; innovate; innovative; innovation; risk selection; clinical relevance; clinically relevant; Implant; implantation; comparative; commercialization; aged population; population aging; aging population; combat; standard of care; Sterilization; tissue repair; Formulation; surgical outcome; surgery outcome; cardiac implant; safety assessment; infection management; implant related infection; implant associated infection; financial burden; financial distress; financial strain; financial stress; Financial Hardship; drug release profile; burden of infection; infection burden; rate of infection; infection rate
