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

ARRAY：一种新型聚合物网，用于心脏植入电子设备的预防性抗生素保护

基本信息

批准号：
10600803
负责人：
Jiayi Yu
金额：
$ 100万
依托单位：
21MEDTECH LLC
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-02-01 至 2025-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10600803
关键词：
Address Amino Acids Animal Model Animals Antibiotic Therapy Antibiotics Bacteria Cardiovascular system Cefazolin Colony-forming units Cyclic GMP Data Development Device Removal Devices Dose Drug Kinetics Electronics Esters Exhibits Film Financial Hardship Formulation Goals Gram-Negative Bacteria Hernia Hospital Costs Hospitalization Hour Implant In Vitro Incidence Infection Infection prevention Inflammatory Response Kinetics Label Licensing Marketing Methods Minocycline Modeling Morbidity - disease rate Operative Surgical Procedures Oryctolagus cuniculus Outcome Patients Pharmaceutical Preparations Pharmacodynamics Phase Polyesters Polymers Population Postoperative Period Preparation Procedures Quality of life Rattus Residual state Rifampin Risk Safety Series Skin Sterilization Surgical Replantation Thick Time Titanium Urea aging population biodegradable polymer biomaterial compatibility cardiac implant clinically relevant combat commercialization comorbidity comparative controlled release copolymer design dosage drug release profile implant associated infection implantable device implantation improved in vivo infection burden infection management infection rate innovation microbial mortality non-opioid analgesic novel pathogen prevent prophylactic risk selection safety assessment soft tissue standard of care stoichiometry success surgery outcome tissue repair

项目摘要

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.

项目概要 21MedTech, LLC 正在开发 ARRAYTM 抗生素负载信封，以满足对新方法的需求解决与心血管植入电子设备 (CIED) 相关的不断上升的感染率。那里 2011 年植入了 150 万个 CIED，而且这个数字还在继续增长。 1% 到 4% 之间植入会导致感染，这可能会导致严重的发病率和死亡率。死亡率如果不移除装置，CIED 相关口袋感染的发生率可高达 66%，最高可达 18% 去除装置和抗生素治疗。为了解决需要其他方法来减少或防止针对这些感染，21MedTech 正在开发 ARRAY 包膜以提供长期保护。阵列包膜采用新型生物可吸收聚合物薄膜，有助于利福平的控制释放和 CIED 手术植入后局部使用米诺环素。包络高度可调，可实现控制超过药物释放和降解时间，并已被证明在体内具有高度生物相容性。在此之前直接进入II期提案，21MedTech已在体外证明了包膜材料的安全性和有效性并已证明在 28 天内控制释放利福平和米诺环素的可行性。 21MedTech 还展示了比市售 TYRXTM 包膜更好的药物释放曲线在体外，在前 24 小时内表现出爆发释放 (>90%)。该提案的目标是优化抗生素从包膜中释放，评估安全性和有效性，并确定有效剂量明确的动物模型。这些目标的成功将推动 ARRAY 获得 FDA 批准。 ARRAY 信封的商业化将改善 CIED 手术结果并提高患者质量通过减少 CIED 相关感染来提高生活质量。