Atlanta (March 29, 2022) – David E. Kandzari, M.D., an interventional cardiologist with Piedmont Heart Institute, treated the first patient in the SPYRAL AFFIRM clinical trial at Piedmont Atlanta Hospital. Dr. Kandzari, who is Chief of the Piedmont Heart and the Cardiovascular Service Line; Director, Interventional Cardiology of the Piedmont Heart; and Chief Scientific Officer for Piedmont Healthcare, is serving as one of two global principal investigators on the study.
Medtronic (NYSE:MDT) announced the initiation of the SPYRAL AFFIRM study in November; Dr. Kandzari treated the first patient in December. The study evaluates the long-term safety, efficacy, and durability of the Medtronic Symplicity™ Spyral Renal Denervation System in real-world patients with uncontrolled hypertension and comorbidities such as diabetes (type 2), isolated systolic hypertension, and chronic kidney disease.
“At Piedmont, we are changing health care and participating in trials like this allows us to offer the most innovative treatments to our patients,” Dr. Kandzari said. “We are proud to have treated the first patient in the SPYRAL AFFIRM study at Piedmont Atlanta and look forward to reviewing the data at the conclusion of the trial.”
Using a performance goal, this clinical study will enroll up to 1,000 real-world patients with uncontrolled hypertension and associated comorbidities, such as isolated systolic hypertension, diabetes, and chronic kidney disease. SPYRAL AFFIRM 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.
“Through the strong investment in our clinical program, the AFFIRM study will expand RDN research into a variety of patient groups,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. “The AFFIRM clinical study adds to our body of evidence for RDN and will help us further answer questions about the use of this procedure in more complex, real world patients such as those with isolated systolic hypertension, diabetes and chronic kidney disease.”
The SPYRAL AFFIRM clinical study is part of the SPYRAL HTN Global Clinical Program, adding to the safety and efficacy data for RDN. Along with the real-world data from the Global SYMPLICITY Registry, when combined with commercial experience, there have been more than 20,000 procedures performed with Medtronic RDN technology.
The clinical program is backed by the most rigorous and extensive patient experience studied in the presence and absence of medication and in patients with high baseline cardiovascular risk.