ReCor Medical Reports 100% Responder Rate at One-Year Follow-up in Clinical Trial of Its Ultrasound-Based PARADISE™ Renal Denervation System for Treating Resistant Hypertension, a Major Risk Factor for Cardiovascular Disease
ReCor Medical reported one-year follow-up data on patients who have been treated via renal denervation for their resistant hypertension with the Company's PARADISE® System—the only CE-marked system for renal denervation that is based on ultrasound, not radiofrequency, energy. The data were presented at TCT 2012 from the podium by Peter Fitzgerald, M.D., Ph.D., Associate Professor of Medicine (Cardiology), Associate Professor of Electrical Engineering (by courtesy), and Co-Director of the Center for Research in Cardiovascular Interventions at Stanford University School of Medicine. Additionally, Dr. Fitzgerald serves as Director of Core Cardiovascular Analysis Lab at Stanford.
The data showed that 100% (15/15) patients have responded favorably to their PARADISE treatment. Three of these responders are now out to one-year follow-up. The accepted industry standard for a ‘responder' is defined as >10 mm Hg systolic office blood pressure reduction. The scientific literature demonstrates that only a 5 mm Hg reduction in blood pressure results in a 14% decrease in stroke, a 9% decrease in heart disease, and a 7% decrease in mortality.
“These preliminary clinical results, with all of the PARADISE patients responding to treatment, are very compelling and dramatically underscore a significant competitive advantage for ReCor's ultrasound-based PARADISE system compared to radiofrequency-based standard of care for treating resistant hypertension patients,” said Mano Iyer, CEO, ReCor Medical. “The benefit of our ultrasound approach is that PARADISE is designed to simultaneously penetrate much deeper into the tissue, up to 10 millimeters, and heat circumferentially, to target all of the renal nerves in one location. Our unique approach is in stark contrast to radiofrequency, which is limited with its depth of penetration to just a few millimeters, as well as its inability to heat circumferentially in any given location. Data presented at TCT 2012 concluded that renal nerves are actually much further at depth than previously thought, and run circumferentially around the renal arteries, which underscores the PARADISE ultrasound advantage.”
About ReCor Medical, Inc.
ReCor is a private venture-backed, early-stage company developing novel therapeutic ultrasound catheter technology. ReCor is backed by European and U.S. investors including Sofinnova Partners, one of the largest life science investors in Europe. The Company's PARADISE™ ultrasound catheter, which is CE-marked, is designed with the aim to allow complete circumferential denervation more consistently and efficiently than the standard of care radiofrequency ablation catheter. For more information about ReCor Medical, please visit www.recormedical.com.
NOTE: PARADISE™ is approved for sale in Europe; it is not approved for sale or investigational use in the United States.
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005 x108