Non-invasive cloud connected device for hemodynamic-guided therapy toimprove outcomes for heart failure patients

用于血流动力学引导治疗的非侵入性云连接设备，可改善心力衰竭患者的治疗结果

基本信息

批准号：
10012038
负责人：
Kaustubh Kale
金额：
$ 150万
依托单位：
AVENTUSOFT, LLC
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-06-01 至 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10012038
关键词：
Acute Algorithms Blinded Blood Blood Pressure Blood Pressure Monitors Brain natriuretic peptide Businesses Cardiac Catheterization Procedures Cellular Phone Cessation of life Clinic Clinic Visits Clinical Clinical Research Clinical Trials Clinical assessments Collaborations Complement Congestive Continuity of Patient Care Data Detection Development Devices Diagnosis Diuretics Early Diagnosis Echocardiography Electrocardiogram Emergency Care Enrollment Environment Etiology Event Florida Fluid overload Goals Gold Guidelines Health Professional Heart failure Home environment Hormones Hospital Charges Hospitalization Hospitals Human Resources Image Institutional Review Boards Intervention Lead Length of Stay Liquid substance Measurement Measures Medical Medical Device Methods Monitor Morbidity - disease rate Multi-Institutional Clinical Trial Multi-site clinical study Outcome Outpatients Pathway interactions Patient Recruitments Patient Representative Patients Performance Phase Physicians Prevention Public Health Pulmonary artery structure Quality of Care Randomized Risk Sampling Single-Blind Study Site Small Business Innovation Research Grant System Technology Testing Therapeutic Intervention Time Transducers Universities Validation Weight Work base biomaterial compatibility clinical practice commercialization cost design economic impact evidence base hemodynamics hospital readmission improved improved outcome innovation insight mortality novel portability pressure prospective standard of care time interval trend verification and validation

项目摘要

7. PROJECT SUMMARY/ABSTRACT This SBIR Fast-Track project will develop an innovative non-invasive cloud connected device for hemodynamic-guided therapy to improve outcomes in Heart Failure (HF) patients, validated through a multi- center clinical trial to support FDA 510(k) clearance. The standard telemonitoring interventions involving objective monitoring of blood pressure, weight, electrocardiograms, or rhythm strips for review, have not demonstrated reduction with respect to readmission for any reason or death of any cause within 180 days after enrollment. Invasive devices have demonstrated that ambulatory pulmonary artery pressures (PAPs) hemodynamic measurement allow more effective HF management leading to fewer hospitalizations. Thus, given the clinical and economic impact of HF hospitalizations, and in view of the risk and cost of invasive monitoring there is a need for non-invasive, affordable, accurate, absolute and actionable hemodynamic measurement methods that can monitor HF patients in the clinic and at home. Providing an effective method for early detection of congestion and guided therapy intervention to avoid hospitalization. The ability of a device to allow the management of HF patient across the continuity of care from the emergency department, to in- patient, to out-patient clinic, and to the home, would be of tremendous value. Towards this goal of HF management, Aventusoft has developed a novel non-invasive medical device (HEMOTAG) enabling specific measurements of hemodynamics, anywhere, anytime by anyone. Aventusoft has completed multiple Institutional Review Board approved clinical studies to demonstrate the major clinical advancement. Phase I and II activities will focus on larger multi-center clinical studies, enhancing the HEMOTAG technology for hemodynamic guided therapy to improve outcomes in heart failure patients, reducing HF hospitalization, mortality, morbidity, and improving quality of care through remote monitoring and timely intervention. Resulting in FDA 510(k) indications of use, for HEMOTAG guided treatment for HF patients. The development of a non- invasive, accurate and easy-to-use solution that can provide actionable targets measurements without requiring an echocardiogram imaging or right heart catheterization, will have great potential not only for HF management but for many other etiologies as well. Aventusoft’s HEMOTAG provides a complement or replacement for expensive devices currently required for measuring the pulmonary artery pressures. The HEMOTAG device can enable reliable, accurate, absolute, actionable and easy-to-use application by healthcare professionals and by patients at home, for the early detection of congestive exacerbations due to fluid overload. It overcomes the limitations of cost, size, accessibility and availability of skilled personnel requirements of existing devices. HEMOTAG verification and validation would be completed during the Phase II. Followed by commercialization in Florida and nationwide, based on the business partnerships and clinical collaborations established to help create a commercially successful product.

7。项目摘要/摘要这个SBIR快速轨道项目将开发创新的非侵入性云连接设备血液动力学引导的治疗以改善心力衰竭（HF）患者的预后，通过多种中心临床试验以支持FDA 510（k）清除。涉及的标准远程监控干预措施客观监测血压，体重，心电图或节奏条以进行审查，尚未出于任何原因或死亡的任何原因在180天内出于任何原因或死亡而显示出降低注册。侵入性装置表明，卧床肺动脉压力（PAP）血液动力学测量可提供更有效的HF管理，从而减少住院治疗。那，鉴于HF住院的临床和经济影响，以及侵入性的风险和成本监视需要非侵入性，负担得起，准确，绝对和可起作的血液动力学可以在诊所和家里监测HF患者的测量方法。提供有效的方法早期发现充血和指导治疗干预以避免住院。设备的能力为了使HF患者的管理在整个出现部门的护理连续性中，患者到门诊诊所和家中，将具有巨大的价值。达到HF的目标管理层，Aventusoft开发了一种新颖的非侵入性医疗设备（Shemotag），以实现特定任何人随时随地对血液动力学的测量。 Aventusoft已完成多个机构审查委员会批准了临床研究，以证明主要的临床进步。第一阶段 II活动将集中于更大的多中心临床研究，从而增强了Shemotag技术血液动力学指导疗法以改善心力衰竭患者的预后，减少HF住院治疗，通过远程监控和及时干预，死亡率，发病率和改善护理质量。结果在FDA 510（k）使用指标中，用于HF患者的血液引导治疗。非 - 的发展侵入性，准确且易于使用的解决方案，可以提供可行的目标测量值需要超声心动图成像或正确的心脏导管插入术，不仅对HF具有巨大的潜力管理，但也适用于许多其他病因。 Aventusoft的Shemotag提供了完成或替换目前所需的昂贵设备来测量肺动脉压力。这 Shemotag设备可以通过医疗保健专业人员和家里的患者，以早期发现由于流体超负荷。它克服了成本，规模，可及性和熟练人员的可用性的局限性现有设备的要求。在阶段将完成Shemotag验证和验证 ii。然后根据业务合作伙伴关系和临床在佛罗里达州和全国范围内进行商业化建立的合作旨在帮助创建商业上成功的产品。