SMILE Heart Failure Clinical Trial Primary Results Presented at HFSA 2019
Study results indicate that the non-invasive ReDS™ system for monitoring pulmonary congestion significantly reduces the leading cause of hospitalizations in the US when used as intended.
Sep 16, 2019, 18:47 ET
PHILADELPHIA, Sept. 16, 2019 /PRNewswire/ -- Today at the Heart Failure Society of America Annual Meeting Dr. William T. Abraham the SMILE national principle investigator presented the results of the study as a late breaking trial. The study examined use of ReDS™ non-invasive remote monitoring of pulmonary congestion for the management of heart failure patients. The SMILE trial demonstrated that when used as intended, REDS-guided heart failure management prevented 58% of heart failure readmissions. Data was collected from 268 patients by 43 centers across the United States, constituting the largest RCT to date on the impact of ReDS™ on managing heart failure. Patients were recruited for the study during hospitalization and followed for up to 9 months at home. Daily measurements were taken using ReDS™ with the goal of keeping lung fluid within the normal range of 20%-35%. Data aggregated in the cloud was sent to physicians to monitor and adjust medication with the goal to keep patients fluid status balanced and avoid readmission.
"The results show that with an accurate and absolute measurement of lung fluid content, physicians have actionable information to help make treatment decisions," said Dr. Abraham, Professor of Medicine at The Ohio State University. "When ReDS measurements are taken regularly by patients and physicians use this information to guide therapy, the SMILE trial demonstrates a reduction in hospital readmissions for heart failure."
"This much data aggregated from so many high-powered centers is a huge step in showing the value ReDS can deliver heart failure patients," said Amir Ronen, Sensible Medical CEO. "We will continue to innovate and expand on the evidence generated with the SMILE Study."
About the ReDS™ & ReDS™ Pro systems
The ReDS™ system is an accurate measurement tool to evaluate pulmonary congestion providing additional information to assist a physician in their assessment of a patient's condition. Two days ago, Sensible Medical announced the ReDS™ PRO, utilizing the same technology of the ReDS™ optimized for point-of-care use. Assessment with the aid of ReDS™ technology has helped physicians at facilities across the country to better manage their patients' heart failure, with the goal of avoiding readmission.
For additional information about the capability at Sensible Medical Innovations contact Eran Kurman,
Or for information about ReDS™ or Sensible Medical please contact info@sensible-medical.com
Contact: Eran Kurman, VP Sales & Marketing
Phone: 917-434-4202
Email: Eran.K@sensible-medical.com
SOURCE Sensible Medical
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