权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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：
10117097
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 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10117097
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 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 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 detection method economic impact efficacy evaluation evidence base hemodynamics hospital readmission improved improved outcome innovation insight mortality novel portability pressure prospective remote monitoring standard of care telemonitoring 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. 项目总结/文摘