ARRAY: A novel polymeric mesh for prophylactic antibiotic protection of cardiac implantable electronic devices

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PROJECT SUMMARY 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.