The SIRONA trial will enroll up to 10 patients at two European sites. The primary safety endpoint is freedom from adverse events related to use of the system through 30-days post sensor implantation. Accuracy of the Cordella PA Pressure Sensor readings as compared to a fluid-filled PA pressure measurement taken by right heart catheterization (RHC) at 90-days is the primary efficacy endpoint.
About Endotronix
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Endotronix, Inc., a medical technology company, is developing an integrated platform to provide comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. The company's solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data system and at-home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure. Learn more at http://www.endotronix.com.
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1Abraham WT, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomized control study. Lancet. 2011 Feb 19;377(9766):658-66
2 Abraham WT, Adamson PB, et al. (2015, March). Pulmonary artery pressure management in heart failure patients with reduced ejection fraction significantly reduces heart failure hospitalizations and mortality above and beyond background guideline-directed medical therapy. Abstract 902-04 presented at ACC 2015, San Diego, California.
SOURCE Endotronix, Inc.
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