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June 5, 2024
Baylis’ PowerWire Pro RF Guidewire Used in First Commercial Case to Treat In-Stent Restenosis
June 5, 2024—Baylis Medical Technologies announced the completion of its first clinical use of the PowerWire Pro radiofrequency (RF) guidewire to cross a chronically occluded peripheral stent safely. The device utilizes RF energy to vaporize a channel through occlusions, allowing for successful crossing and subsequent revascularization of the iliocaval stent. In March, the company announced FDA 510(k) clearance of the PowerWire Pro RF guidewire to cross occluded peripheral vessels, including those with stents.
The initial procedure was performed in April 2024 by Mark Iafrati, MD, in Nashville, Tennessee.
According to the company, the patient had a chronically occluded stent that extended from the inferior vena cava down to the left common iliac vein. Previous attempts to cross the occlusion with mechanical tools were unsuccessful, likely because of the dense fibrotic nature of the occlusion. The patient was brought back and Dr. Iafrati performed the procedure with the PowerWire Pro RF guidewire.
“This marks a significant advancement in the treatment of patients with in-stent restenosis,” commented Dr. Iafrati in Baylis’ press release. “I was able to easily cross the occluded stents with the PowerWire Pro RF guidewire when my standard tools had failed.”
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