Atlanta, Ga. (October 12, 2023) – Piedmont Atlanta Hospital has treated 25 patients in the SPYRAL AFFIRM Clinical Study, making it the leading enrolling site in the United States, 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 and comorbidities (i.e., isolated systolic hypertension, diabetes, and chronic kidney disease).
Piedmont Atlanta Hospital also has consented 46 patients overall for the trial. David E. Kandzari, M.D., Chief of the Piedmont Heart Institute and Cardiovascular Service Line, is a national principal investigator for the trial.
High blood pressure (also known as hypertension) is a blood pressure reading that is higher than normal (or greater than 130/80 mm Hg). An estimated 1.28 billion adults aged 30-79 years worldwide have hypertension, with most (two-thirds) living in low and middle-income countries. Since high blood pressure often has no symptoms, many people don’t know they have it. Although approximately 1 in 5 adults (21%) with hypertension have it under control, an estimated 46% of adults with hypertension are unaware they have the condition, and less than half of adults (42%) with hypertension are diagnosed and treated. Increasing awareness is key to tackling the issue of hypertension given it is preventable, detectable, and treatable.
The blood pressure procedure known as the Symplicity Blood Pressure Procedure is a minimally invasive technique that targets specific nerves near the kidneys that can become overactive and cause high blood pressure. The procedure works by delivering radiofrequency (RF) energy to these overactive nerves to decrease their activity. Risks related to the investigational procedure include but are not limited to pain and/or a type of bruising known as hematoma.
“High blood pressure is a significant problem for people all around the world. For patients with hypertension, medication and/or lifestyle changes can help reduce blood pressure, but studies have shown that many people are still non-adherent to their hypertension medication regimen,” said Dr. Kandzari. “This study will evaluate if the Symplicity procedure can provide patients with a blood pressure reduction benefit that is ‘always on.’ We are proud to be involved in this innovative clinical program and look forward to the findings of the SPYRAL AFFIRM Clinical Study.”
Using a performance goal, the SPYRAL AFFIRM Clinical Study will enroll 1,000 patients with uncontrolled hypertension and associated comorbidities, such as isolated systolic hypertension, diabetes, and chronic kidney disease. The study will follow these patients for three years. This investigational device exemption trial was approved by the U.S. Food and Drug Administration (FDA) in June 2021 and will be conducted at 100 sites globally.
The SPYRAL AFFIRM Clinical Study is part of the SPYRAL HTN Global Clinical Program, adding to the safety and efficacy data for the Symplicity Spyral Renal Denervation System. The Symplicty Spyral renal denervation system is limited to investigational use in the United States, Japan, and Canada.
To learn more about the clinical study, please visit this link, or reach out to your physician.