Cardiovascular, Research & Technology
Corewell Health Treats First Patients in Hypertension Clinical Trial
International study looks to enroll up to 1,000 patients
January 17, 2024
Grand Rapids, Mich., Jan. 17, 2024 – Corewell Health TM has treated its first patients in the SPYRAL AFFIRM Clinical Study and continues to enroll patients. The study evaluates the long-term safety, efficacy, and durability of the Medtronic Symplicity Spyral renal denervation system in patients with uncontrolled hypertension.
The procedure, which received US Food and Drug Administration approval in November, is a minimally invasive technique that targets specific nerves near the kidneys that can become overactive and cause hypertension, also known as high blood pressure. The procedure works by delivering radiofrequency energy to these overactive nerves to decrease their activity.
Corewell Health is one of 34 sites in the United States and one of just four sites in Michigan participating in the clinical study.
“The management of hypertension has been unchanged for many years even though it is preventable, detectable and treatable,” said Araya Negash, D.O., the primary investigator and an interventional cardiologist at Corewell Health who performed the procedure at Corewell Health in West Michigan. “Renal denervation with the Medtronic Symplicity Spyral system is a novel modality that may help reduce high blood pressure in patients with uncontrolled hypertension.”
Hypertension affects an estimated 1.28 billion adults worldwide. The goal of the clinical trial is to enroll 1,000 patients in the U.S. Dr. Negash and the study team at Corewell Health have enrolled five patients so far, and plan to enroll 40 patients over the next two years. Risks related to the procedure include, but are not limited to, pain and/or a type of bruising known as hematoma.
To learn more about the clinical study, please visit this link, or reach out to your physician.