First Patient in World Enrolled in RADIANCE-II Study for High Blood Pressure
First release of six-month follow-up data from earlier phase to be presented at ACC19
MINNEAPOLIS / March 17, 2019: The Minneapolis Heart Institute Foundation® (MHIF) has become the first clinical research site worldwide to randomize a patient in ReCor Medical’s RADIANCE-II multicenter clinical study. This study is the pivotal randomized blinded study of Recor’s Paradise® Ultrasound Denervation System for the treatment of high blood pressure.
High blood pressure affects more than one billion people worldwide, yet nearly one in three individuals struggle to control their blood pressure despite being on medication. For a growing subset of patients, medications either don’t work or are not tolerated, which puts them at greater risk of serious complications.
The study is evaluating the safety and effectiveness of the Paradise System, an investigational device that focuses on the nerves around the renal (kidney) arteries that may be overactive in patients with high blood pressure. During a minimally invasive procedure, surgeons place a small, flexible catheter into the renal arteries leading to the kidneys and then deliver ultrasound energy to the tissues around the renal arteries to decrease over-activity of the nerves.
Under the leadership of Minneapolis Heart Institute® cardiologist and MHIF researcher Dr. Yale Wang, MHIF is one of the leading global centers involved in studying the system. MHIF acquired 66 consents and performed 14 randomizations in the ongoing RADIANCE-HTN SOLO study, which completed randomization in December 2017. Two-month results presented in May 2018 at EuroPCR 2018, with simultaneous publication in The Lancet, showed that the SOLO Cohort met its primary efficacy endpoint and demonstrated a statistically significant reduction in blood pressure in hypertensive patients. Results demonstrated a 6.3 mmHg greater reduction in daytime ambulatory systolic blood pressure at two months by endovascular ultrasound renal denervation (RDN) compared with a control procedure.
“We are pleased to be a world leader in this important research on an innovative and promising treatment for people with essential and resistant hypertension, particularly for those patients who may not have many other options,” said Dr. Wang.
On March 17, 2019, researchers presented six-month follow-up data from the SOLO Cohort at the American College of Cardiology’s 68th Annual Scientific Session in New Orleans. Researchers reported six-month results following the addition of a recommended standardized stepped-care antihypertensive treatment to the randomized treatment. Compared with a control procedure where no RDN treatment is applied, the blood pressure-lowering effect of endovascular ultrasound RDN was maintained at six months with less prescribed antihypertensive medications.
About the Minneapolis Heart Institute Foundation®
The Minneapolis Heart Institute Foundation (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, it is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.
- Scientific Innovation and Research — MHIF is a recognized research leader in the broadest range of cardiovascular medicine and population health initiatives. Each year MHIF leads more than 175 active research projects and publishes more than 175 peer-reviewed abstracts. Cardiologists, hospitals and communities around the world adopt MHIF protocols to save lives, improve care and create healthier living opportunities.
- Education and Outreach — MHIF provides more than 10,000 hours of education each year putting its research into practice to improve outcomes. And, MHIF leads cutting-edge, transformative population health research to connect, engage, inform and empower individuals and communities to improve their health.
The Minneapolis Heart Institute Foundation’s work is funded by generous donors and sponsors and supports research initiatives of Minneapolis Heart Institute® at Abbott Northwestern Hospital. Minneapolis Heart Institute® physicians provide care for patients at Abbott Northwestern Hospital in Minneapolis and at 38 community sites across Minnesota and western Wisconsin. More information can be found at https://mplsheart.org
About ReCor Medical, Inc.
ReCor Medical is a medical device company that designs and manufactures the Paradise® System, a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent global 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. The Paradise System has been studied in clinical trials of approximately 300 patients to date. For additional information visit www.recormedical.com.