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Medical Devices / Regulatory Affairs / Submissions and Approvals

Medtronic Nabs Dual Approval for Renal Denervation System

Dec. 10, 2013

Minnesota-based device giant Medtronic plans a phased commercial roll-out of the 4 Fr multi-electrode Symplicity Spyral catheter and Symplicity G3 radio frequency (RF) generator in the EU and Australia, following the system’s approval by regulators in both markets.

The Symplicity Spyral catheter and Symplicity G3 generator are currently available in many places in Germany and the Netherlands, Medtronic spokeswoman Wendy Dougherty told Device Daily Bulletin. The catheter features four electrodes that are able to deliver either simultaneous or selective RF energy into the renal artery wall to disrupt the output of overactive sympathetic nerves.

According to Michael Böhm, chair of the Department of Internal Medicine at the University of Saarland in Germany, the multi-electrode Symplicity system builds on Medtronic’s single-electrode Symplicity system “by helping significantly reduce ablation time.”

The 4 Fr catheter is compatible with a 6 Fr guide catheter and is delivered across a 0.014 inch guide wire via a rapid exchange system. Due to its nonocclusive design, the catheter will not obstruct renal blood flow during the procedure, Medtronic said.

Medtronic estimates that about 1.5 billion people worldwide will have hypertension by 2025. Given that 30 percent to 50 percent of people with hypertension are treatment-resistant, “we estimate the potential market size for RDN for this indication to be approximately 4 million patients in the U.S., 4 million patients in Japan and 5 million patients in Europe,” Dougherty said.

“However,” she added, “it is important to note that these numbers are estimates and not all patients may be appropriate for RDN as comorbidities and other factors may make them ineligible.” — Nick Otto

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