Iridium-electrode inhaled Nitric Oxide generator for treatment of hypoxic respiratory failure in neonates

铱电极吸入一氧化氮发生器治疗新生儿缺氧性呼吸衰竭

• 批准号: 9199502
• 负责人: Philip E Silkoff
• 金额: $ 75.45万
• 依托单位: THIRD POLE, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9199502
• 关键词: Acute; Adult; Air; American; Anesthesia procedures; Animals; Breathing; Catheterization; Childhood; Clinical; Clinical Research; Clinical Trials; Complex; Computer software; Custom; Data; Development; Devices; Electrodes; Ensure; Etiology; Factor Analysis; Gases; General Hospitals; Goals; Grant; Heart failure; Hospitals; Human; Hypoxia; Infant; Inhalation Therapy; Intervention; Interview; Iridium; Laboratories; Life; Literature; Lung; Maps; Marketing; Massachusetts; Mechanical Ventilators; Medical; Medical Device; Medicine; Modeling; Monitor; National Heart, Lung, and Blood Institute; Neonatal Intensive Care Units; Nitric Oxide; Nitrogen Dioxide; Oxygen; Patients; Penetration; Phase; Price; Probability; Pulmonary Hypertension; Readiness; Reporting; Research; Respiratory Failure; Safety; Series; Small Business Innovation Research Grant; System; Technology; Testing; Therapeutic Equivalency; Time; United States Food and Drug Administration; Vasodilation; Vasodilator Agents; Visit; Work; abstracting; base; cost; design; electric impedance; experience; healthy volunteer; inhaled nitric oxide; neonate; novel; particle; programs; prototype; pulmonary arterial hypertension; respiratory; safety testing; sensor; success; uptake; usability; user-friendly

Abstract We propose to develop a medical device building on an existing clinical prototype that generates medical grade nitric oxide (NO) from air for inhalation. An iridium-electrode inhaled NO generator will supersede existing devices which utilize NO cylinder supply chains and complex bedside administration systems, and vastly increase worldwide access to this lifesaving pediatric selective pulmonary vasodilator. Inhaled NO produces pulmonary vasodilation without systemic vasodilation, which is a significant issue with other currently available therapies. In December 1999, the US Food and Drug Administration (FDA), approved inhaled NO for the treatment of hypoxic term or near-term infants with hypoxic respiratory failure (HRF) since which time inhaled NO has been a life-saving intervention for hospitalized infants to treat acute pulmonary hypertension. Our collaborators in the Zapol lab at MGH recently reported on data obtained from testing a 110V AC-powered bedside NO generating device in a lamb model of pulmonary artery hypertension (PAH). This prototype was subsequently tested in a human proof of concept (POC) trial in 6 healthy volunteers and to date 5 patients with PAH in the MGH catheterization lab. Third Pole and the Zapol lab have commenced work under NHLBI B-BIC/NCAI grant #U54HL119145 to optimize the electrode design of an NO generator for use with mechanical ventilators and anesthesia machines. We will develop an iridium-electrode NO generator with expert clinician input under FDA design controls which will serve as a basis for clinical bioequivalence studies anticipated to be required for regulatory approval. Development in the academic setting has not yet been conducted under formal FDA design controls, a requirement for obtaining IDE status and entering broader clinical trials. An iridium-electrode inhaled NO generator, with optimal materials and design will enable worldwide provision of NO inhalation therapy for infants with HRF.

抽象的 我们建议在现有临床上开发医疗设备建筑物 产生医学级一氧化氧化氧化氧化物（NO）以吸入的原型。 虹膜电极吸入没有发电机将取代现有的设备 使用没有气缸供应链和复杂的床头给药系统， 并大大增加了全世界享受这种救生的儿科选择性的机会 肺血管扩张剂。 吸入无全身性会产生肺部血管舒张 血管舒张，这是其他当前可用疗法的重要问题。 1999年12月，美国食品药品监督管理局（FDA）批准 吸入NO治疗缺氧期或近期婴儿缺氧 从那以后，呼吸衰竭（HRF）吸入的时间却是挽救生命的 住院婴儿治疗急性肺动脉高压的干预措施。 我们在MGH的Zapol实验室中的合作者最近报告了数据 通过测试110V AC驱动的床边无生成设备获得 肺动脉高压（PAH）的羔羊模型。这个原型是 随后在人类的概念证明（POC）试验中测试了6个健康 在MGH导管实验室中，志愿者和5例PAH患者。第三 Pole和Zapol Lab已在NHLBI B-BIC/NCAI Grant下开始工作 ＃U54HL119145，以优化无生成器的电极设计 机械呼吸机和麻醉机。 我们将与专业临床医生一起开发一个没有发电机的虹膜电极 FDA设计控件下的输入将作为临床的基础 预计将需要进行监管批准的生物等效性研究。 在学术环境中的发展尚未根据正式进行 FDA设计控件，获得IDE状态并进入更广泛的要求 临床试验。带有最佳材料的虹膜电极没有发电机 设计将使无婴儿疗法在全球范围内为婴儿提供 与HRF。