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Results from the pivotal RADIANCE II Trial Presented at TCT

BOSTON – September 18, 2022 – Findings from the large scale, pivotal, multicenter, sham-controlled RADIANCE II randomized trial found that endovascular ultrasound renal denervation (uRDN) was superior in lowering blood pressure (BP) compared with a sham procedure.

Findings were reported today at TCT 2022, the 34^th annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

Although uRDN has been shown to lower BP in patients with both mild-to-moderate hypertension (HTN) and HTN resistant to a triple combination pill, the sample sizes of prior trials have been limited. RADIANCE II is the largest individually powered randomized trial designed to determine the safety and effectiveness of uRDN among patients with uncontrolled mild-to-moderate hypertension

Patients with HTN (seated office BP ≥140/90 mmHg and <180/120 mmHg) on no more than two anti-HTN medications underwent a four-week observation time during which they were taken off all HTN medications. Those who remained clinically stable after the observation period and whose BP remained elevated with daytime ambulatory systolic BP (ASBP) greater than or equal to 135/85 mmHg but less than 170/105 mmHg underwent anatomic screening with CTA/MRA. Those with qualifying renal artery anatomy proceeded to renal angiography, and if angiography re-confirmed suitability for uRDN, they were then randomized 2:1 to receive bilateral uRDN of the main and accessory (≥3 mm) renal arteries or a sham procedure.

Between March 2019 and May 2022, a total of 150 patients received uRDN and 74 underwent a sham procedure. Baseline characteristics including ambulatory blood pressure and the number of anti-hypertensive medications were similar between both groups. The primary efficacy endpoint was the change in ASBP at two months. The change in ASBP was -7.9 mmHg for the uRDN group compared to -1.8mmHg for the sham group. The between-group difference was -6.3 mmHg (95%CI, -9.3 to -3.2, p<0.0001. In addition, the secondary efficacy endpoints of change in 24-hour, nighttime, home, and office systolic blood pressure showed statistically and clinically significant reductions (∆5-7 mmHg versus sham). There were also no major adverse events in either group through 30 days.

“The pivotal RADIANCE II trial is the largest individually powered randomized study to confirm the superiority of endovascular uRDN in lowering blood pressure compared to a sham procedure,” said Ajay J. Kirtane, MD, SM, Professor of Medicine, Columbia University Irving Medical Center, Director, Cardiac Catheterization Laboratories, New York-Presbyterian/Columbia University Irving Medical Center and Chief Academic Officer, Columbia Interventional Cardiovascular Care. “These positive outcomes build upon prior trial results demonstrating that uRDN lowers blood pressure across the spectrum of hypertension. This is an important next step in providing optimal care for patients and we look forward to continuing research to determine whether the blood pressure lowering effect of uRDN remains durable and safe over time.”

The study funded by ReCor Medical, Inc.

Dr. Kirtane reported the following disclosures: institutional funding to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CSI, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, Shockwave Medical, and Merck. In addition to research grants, institutional funding includes fees paid to Columbia University and/or the Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr. Kirtane controlled the content. He also reported consulting from IMDS and travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is one of the world’s leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 30 years, CRF has helped accelerate medical breakthroughs and educated doctors on the latest treatments for heart disease. CRF’s centers of excellence include the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Now in its 34^th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit www.crf.org and www.tctconference.com.

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