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ReCor Medical Announces Completion of RADIANCE-HTN SOLO Hypertension Study

January 5, 2018 by maureensharkey

January 5, 2018 – Palo Alto, CA, for immediate release, – ReCor Medical announced today randomization of its 146th, and final, subject in the SOLO cohort of its RADIANCE-HTN study.  RADIANCE-HTN, ReCor’s study of its Paradise Renal Denervation System in people with hypertension, involves two study cohorts: “SOLO” – whose subjects are removed from anti-hypertensive medication, and “TRIO” whose subjects are put on standardized medication.  Both cohorts are randomized, blinded, sham-controlled, and powered independently for efficacy.

The RADIANCE-HTN 40 study centers – located in the US, France, Belgium, the Netherlands, Germany and the UK – enrolled 1,000 and randomized 165 study subjects in 2017.  The final SOLO subject was randomized at Massachusetts General Hospital, under the lead of Joseph Garasic, MD, interventional cardiologist and Randall Zusman, MD, Director of the MGH Hypertension Clinic.

Completion of the SOLO cohort of RADIANCE marks the largest blinded, sham-controlled, randomized and powered clinical study of renal denervation in an “off-meds” study design.  Lead enrollers were Yale Wang, MD, at the Minneapolis Heart Center; Florian Rader, MD at Cedars Sinai, Los Angeles; Melvin Lobo, MD, at St Bartholomew’s Hospital, London; and Joost Daemen, MD, at the Erasmus Heart Center, Rotterdam, NL.

“Leaders in the hypertension field understand that patients struggle to persevere with multi-drug regimens required to attain and maintain target blood pressure levels over their lifetimes.  The completion of enrollment into the SOLO arm of RADIANCE-HTN is highly significant as this cohort represents the vast majority of hypertensive patients,” commented Melvin Lobo, MD, Director of Barts BP Center of Excellence at St Bartholomew’s Hospital, London.  “If SOLO proves positive, then there may be a pathway, with additional study, to a reduction of medications, increased longer-term therapeutic options, and improved blood pressure control for our patients.”

“ReCor is very pleased to have finished the SOLO cohort of RADIANCE-HTN in record time.  It is a testimony to the interest of patients, and to the support of our study centers in the US and Europe,” commented Helen Reeve-Stoffer, ReCor Medical, VP Clinical Affairs.  “Given the 60-day time point for the SOLO primary efficacy measure, ReCor anticipates outcome analysis and associated publications starting mid-year in 2018.”

 

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Archive

  • Otsuka Medical Devices, Otsuka Holdings and ReCor Medical Announce Signing of Merger Agreement July 10, 2018
  • ReCor Medical Announces FDA Approval of IDE for Pivotal Study of Paradise® Ultrasound Denervation System for Treatment of Hypertension July 2, 2018
  • ReCor Medical Announces RADIANCE-HTN SOLO Hypertension Study Meets Primary Efficacy Endpoint, Pivotal Study Submission, and New Principal Investigator May 23, 2018
  • ReCor Medical To Release Clinical Trial Results May 23 at EuroPCR in Paris May 17, 2018
  • ReCor Medical Announces Completion of RADIANCE-HTN SOLO Hypertension Study January 5, 2018

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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. PARADISE and the Paradise Swirl logo are trademarks of ReCor Medical, Inc.
The PARADISE System is covered by US Patent No. 6763722, 9700372, 9707034, 9943666, 9981108; Other Patents Pending US and OUS.

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