Francis Medical’s Vanquish Water Vapor System Receives the US FDA 510(k) Clearance for Prostate Tissue Ablation

Shots:

• FDA has granted 510(k) clearance to Vanquish Water Vapor System for prostate tissue ablation in pts with intermediate-risk, localized prostate cancer
• Clearance was supported by 12mos. follow-up data on 110 pts first enrolled in the ongoing VAPOR 2 trial (n=235) assessing Vanquish System across the US, with longer-term to support PMA submission
• 6mos. biopsy data showed a 91% elimination rate of targeted MRI-visible ≥GGG2 disease after a single procedure, with effective treatment across all prostate locations. Pts reported minimal pain, & by 12mos., 93% were extremely satisfied or satisfied & 94% felt the treatment was a wise choice

Ref: Francis Medical | Image: Francis Medical | Press Release

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