Robert Segin, CPA Executive VP and chief financial officer | Virtua Health
Robert Segin, CPA Executive VP and chief financial officer | Virtua Health
Virtua Health has commenced patient enrollment for the SPYRAL AFFIRM Clinical Study. This global study aims to assess the long-term safety, efficacy, and durability of the Medtronic Symplicity Spyral Renal Denervation System in patients with uncontrolled hypertension. Virtua Health performed New Jersey's first renal denervation procedure using this system at its Mount Holly hospital in January 2024.
The procedure serves as an additional treatment for those whose high blood pressure cannot be adequately managed through lifestyle changes and medication. "Increasing awareness is key to tackling the issue of hypertension given it is preventable, detectable, and treatable," stated Dr. Kintur Sanghvi, a cardiologist at Virtua Health.
The SPYRAL AFFIRM Clinical Study plans to enroll up to 1,300 patients globally, monitoring them over three years. It will also include up to 100 subjects from previous studies who will be followed for an additional two years.
Symplicity Spyral has been clinically proven to reduce high blood pressure using a minimally invasive technique that targets nerves near the kidneys responsible for elevated blood pressure levels. The process involves inserting a thin tube into the artery leading to the kidney and administering radiofrequency energy to calm nerve activity without leaving any implants behind.
Dr. Sanghvi and his team have already conducted this procedure on more than a dozen patients at Virtua Health. "I have been pleased with the improvements I’ve seen among my patients thus far," Dr. Sanghvi remarked.
One patient, Chris Grasso from Manasquan, N.J., shared his experience with uncontrolled high blood pressure since his early twenties. After participating in this procedure in February 2024, Grasso reported significant improvement in his condition within weeks: "This procedure was life-changing," he said.
For more information about this clinical study or participation details, interested individuals are encouraged to consult their physicians or visit the provided link.
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