The Valley Hospital is Now Enrolling Qualified Patients in SPYRAL AFFIRM Clinical Study

The Valley Hospital is now enrolling patients in the SPYRAL AFFIRM Clinical Study, which evaluates the long-term safety, efficacy, and durability of the Medtronic Symplicity Spyral™ Renal Denervation System – also known as the Symplicity blood pressure procedure – in patients with uncontrolled hypertension and associated comorbidities, such as diabetes and chronic kidney disease.

High blood pressure – also known as hypertension – affects one-third of the adult population – or about 1.1 billion people worldwide. Since high blood pressure often has no symptoms, many people do not know they have it.

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. After mild sedation, the doctor inserts a thin tube into the artery leading to the kidney. The doctor then administers energy to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.

This procedure is approved in the United States for use as an adjunctive treatment – a therapy used in conjunction with a primary treatment option – for those patients who have uncontrolled hypertension and have found that medication and lifestyle modifications do not adequately control their blood pressure.  

Rajiv Tayal, MD, Director of the Cardiac Catheterization Laboratory and the Structural Heart Program at The Valley Hospital, will lead the SPYRAL AFFIRM study at The Valley Hospital.

“Through our participation in the SPYRAL AFFIRM study, we look forward to furthering the treatment of uncontrolled hypertension,” said Dr. Tayal. “I am proud that our hospital is one of the 100 centers globally selected for this study.”

According to study sponsor Medtronic Vascular, the SPYRAL AFFIRM Clinical Study will treat up to 1,300 patients with uncontrolled hypertension. The study will follow these patients for three years. Additionally, up to 100 subjects from prior SPYRAL clinical program studies will be enrolled into AFFIRM and followed for two more years. This study will be conducted at approximately 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, according to Medtronic.

To learn more about this clinical study, please visit ValleyHealth.com/SPYRALAFFIRM.