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News & Events

ReCor Medical Announces IDE Approval for RADIANCE-HTN Hypertension Clinical Trial

February 22, 2016 by Recor Medical

PALO ALTO, Calif. and AMSTERDAM, Feb. 22, 2016 /PRNewswire/ — ReCor Medical, Inc. announced today that it has received FDA IDE approval for the RADIANCE-HTN clinical trial to evaluate the effect of the ReCor Paradise™ Renal Denervation System on blood pressure in patients with hypertension.

RADIANCE-HTN is a blinded, randomized and sham-controlled trial designed to evaluate the blood pressure lowering effect of the Paradise System in two patient populations: those with essential hypertension on two or fewer antihypertensive medications, and those with treatment-hypertension on a minimum of 3 antihypertensive medications.

“RADIANCE-HTN will be led by two Co-Primary Investigators (Co-PIs): Professor Michel Azizi, MD PhD (Georges Pompidou Hospital, Paris, France) and Dr. Laura Mauri, MD, MSc (Brigham & Women’s Hospital, Boston, MA). The study is approved to enroll 292 patients at up to 40 investigational sites, and will be conducted in the US, UK, France, Germany, and The Netherlands. Initial patient enrollment is anticipated in the first quarter of 2016.

Professor Azizi, Co-PI and lead author of the landmark DENER-HTN study, commented; “Many patients across the hypertension spectrum, together with their physicians, are struggling to control their blood pressure. The RADIANCE-HTN trial design will allow us to evaluate the efficacy of the Paradise System in a broad population of hypertensive patients across the hypertension spectrum.”

“There is strong scientific rationale for this study to evaluate renal denervation as a treatment for hypertension,” added Co-PI Dr. Mauri. “We believe that the Paradise System, with its unique combination of circumferential, ultrasound-based nerve ablation and water-based cooling for arterial protection, will be able to denervate the renal nerves with a low incidence of adverse events. RADIANCE-HTN’s blinded, randomized trial design, including standardization of antihypertensive treatment, will allow a robust assessment of the blood pressure reductions important to patients and their physicians.”

Leslie Coleman, DVM, ReCor Vice President of Regulatory and Medical Affairs commented; “We believe that our innovative trial design, evaluating patients both off and on a standard antihypertensive drug regimen, will provide unique insights into the blood pressure effect of our Paradise System.”

“FDA IDE approval of the RADIANCE-HTN trial positions ReCor as one of the few companies in the field who are investing in randomized, blinded and sham-controlled studies with the co-leadership from the hypertension and interventional physician communities,” commented ReCor CEO Andrew M. Weiss. “We believe that this physician partnership is essential for the future establishment of RDN as a standard of care for the treatment of hypertension.”

More information on RADIANCE-HTN can be found at: https://clinicaltrials.gov/ct2/show/NCT02649426?term=radiance&rank=3

About ReCor Medical, Inc. 

ReCor Medical is a private, venture-backed, medical device company that designs and manufactures a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic option for treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation.

For more information about ReCor Medical, please visit www.recormedical.com or contact Andrew M. Weiss, President & CEO, ReCor Medical at aweiss@recormedical.com / +1-650-542-7700.

SOURCE: ReCor Medical

Filed Under: News

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The PARADISE™ system is approved for sale in markets regulated by the CE mark.
Investigational Device in the US, Limited by US Federal Law to Investigational Use Only in the United States
© ReCor Medical, Inc. All rights reserved 2021. PARADISE, RADIANCE, and the Paradise Swirl logo are trademarks of ReCor Medical, Inc.
The PARADISE System is covered by US Patent Nos. 6763722, 8715209, 9352171, 9358401, 9700372, 9707034, 9943666, 9981108, 10039901, 10230041, 10350440, 10368944, 10456605; Corresponding Patents OUS; Other Patents Pending US and OUS.

recormedical.com is ReCor Medical, Inc.’s United States web site (the Site). We control and operate this Site from the United States of America. This Site is intended for use by United States residents only and contains information regarding the Paradise System, which is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. If you are a non-U.S. resident, you may access this Site solely at your own risk and are responsible for compliance with local laws and regulations, if applicable. The trademarks, service marks and logos displayed on www.recormedical.com are registered and unregistered trademarks of ReCor Medical, Inc. PARADISE, RECOR MEDICAL, and the swirl design are ReCor Medical’s trade marks registered in the United States, the European Union, and Japan.

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