MHIF Celebrates a Research Milestone: US FDA Approval of ReCor’s Renal Denervation Technology for Patients with Hypertension

Dec 8, 2023
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Recor Device

The Minneapolis Heart Institute Foundation celebrates a research milestone – and ultimate indication of the importance of research – with the U.S. Food and Drug Administration (FDA) approval of a new treatment for patients living with hypertension. In the last month, ReCor Medical’s Paradise™ Ultrasound Renal Denervation is a first-of-its-kind ultrasound-based renal denervation technology designed to lower blood pressure by denervating overactive sympathetic nerves surrounding the renal arteries. MHIF has been involved in the research of this technology with ReCor since it began in 2016 and was the highest enroller of patients in the U.S. (second highest in the world) of all the clinical sites that participated in the research that was part of the FDA review.

MHIF’s contribution to this research is significant thanks to the multi-disciplinary team of physicians led by Dr. Yale Wang, in collaboration with Drs. Richard Bae, Nedaa Skeik and Desmond Jay, as well as members of the MHIF research team throughout the years of research, including JoAnne Goldman, Amy McMeans, and the late Rose Peterson. Dr. Wang was the only interventional cardiologist trained for this procedure, enrolling every patient in the multiple ReCor RADIANCE clinical studies (multiple trials and updated protocols).

“This is a great example of the impact of research in advancing innovative technologies for patients,” said William Katsiyiannis, MD, President, Allina Health Minneapolis Heart Institute®. “I want to recognize that Dr. Wang, along with support from his partners and members of the research team have made an important contribution through research that resulted in a new treatment option for the many patients living with hypertension.”

Hypertension is the leading contributor to disease burden worldwide, resulting in increased cardiovascular morbidity and mortality, poorer quality of life, and higher costs to health systems. About one-third of the patients treated for hypertension remain uncontrolled despite lifestyle changes and taking more than three medications. The new Paradise system is now available as an adjunct treatment option for patients who have been unable to achieve blood pressure goals with standard lifestyle changes and oral medications.

Congratulations to the amazing team who have collaborated on this research and helped advance care for patients living with hypertension! This milestone that is a great example of the impact that the MHIF Mission can deliver across all the cardiovascular research that happens here.

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