Virtua Health is now enrolling patients in the global SPYRAL AFFIRM Clinical Study, which evaluates the long-term safety, efficacy, and durability of the Medtronic Symplicity Spyral™ Renal Denervation System in patients with uncontrolled hypertension and associated medical conditions. Virtua performed the state’s first renal denervation procedure using the Symplicity system at its Mount Holly hospital in January 2024.

The procedure is an adjunctive treatment for patients whose hypertension (high blood pressure) cannot be sufficiently regulated through lifestyle changes and medication. About one in three adults worldwide – 1.1. billion people – have hypertension.¹

Many people with hypertension have no symptoms and are possibly unaware of their compromised health. Others may experience the symptoms of hypertension, such as kidney or heart dysfunction, before being appropriately diagnosed.²

“Increasing awareness is key to tackling the issue of hypertension given it is preventable, detectable, and treatable,” said Virtua interventional cardiologist Kintur Sanghvi, MD, FACC, FSCCAI. “Virtua is pleased to provide the Symplicity blood pressure procedure to qualified patients and, starting now, to participate in the clinical study.” 

The SPYRAL AFFIRM Clinical Study will enroll up to 1,300 patients worldwide and monitor the participants for three years. Additionally, up to 100 subjects from prior SPYRAL clinical program studies will be included and followed for two more years.

Symplicity Spyral is clinically proven to help reduce high blood pressure,^3-5 which can lower serious health risks.⁶ The procedure uses 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 radiofrequency energy to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind. 

To date, Dr. Sanghvi and his team have performed the renal denervation procedure for more than a dozen patients at Virtua Health.

“I have been pleased with the improvements I’ve seen among my patients thus far. It has reaffirmed my belief that renal denervation represents a significant stride forward in how we mitigate hypertension,” Dr. Sanghvi said. “By participating in the study, Virtua’s patients will contribute to our collective understanding of how to effectively treat hypertension and change lives.”

A Lifetime of High Blood Pressure
Chris Grasso, 61, of Manasquan, N.J., was diagnosed with high blood pressure in his early 20s and has been treated with medications for uncontrolled high blood pressure since his early 30s.

“My blood pressure was 210/160—totally out of control—and my medications were increased every year,” he explained. “In addition, my anxiety level was extremely high because my doctors told me that I had a high risk of suffering a stroke.”

When his cardiologist told Chris that medical options to treat his high blood pressure were becoming scarce, he mentioned a clinical trial assessing the treatment of uncontrolled high blood pressure with renal denervation. Chris began researching and was devastated to learn that the trial had recently closed.

His research, however, led him to Dr. Sanghvi, who explained that although Chris was a perfect candidate for the procedure, FDA approval was required before he could begin performing it. Fortunately, the timing was on Chris’ side this time, and FDA approval followed shortly after that conversation. In February 2024, Chris became the second patient to undergo the Medtronic Symplicity Spyral™ renal denervation procedure at Virtua.

Because the SPYRAL AFFIRM Study is ongoing, Chris’ specific blood pressure measurement cannot be shared, but he is delighted by his personal progress. Within two weeks, his blood pressure decreased and his anxiety regarding an increased risk of stroke disappeared. Over the next six months, his blood pressure continued to drop, and he feels like he truly has a new lease on life.

“This procedure was life-changing,” he said. “Dr. Sanghvi saved my life.”

To learn more about the clinical study, please visit this link, or reach out to your physician.

¹World Health Organization. Hypertension fact sheet. Available at: https://www.who.int/news-room/fact- sheets/detail/hypertension. Accessed February 4, 2022.

² Heart.org. Why High Blood Pressure is a "Silent Killer". 17 November 2017. https://www.heart.org/en/health-topics/high-blood-pressure/why-high-blood-pressure-is-a-silent-killer

³Kandzari DE, Böhm M, Mahfoud F, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. The Lancet. 2018 Jun 9;391(10137):2346-2355.

⁴Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomized, sham-controlled trial. The Lancet 2020; Published online March 29, 2020. DOI: 10.1016/S0140-6736(20)30554-7.

⁵Townsend RR, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. The Lancet. 2017;390:2160–2170.

⁶Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. The Lancet. 2016;387:957-67