IR Update: FDA Clears Emerging Prostate Tissue Ablation System for Intermediate Risk PCa

The Food and Drug Administration (FDA) has granted 510(k) clearance for use of the Vanquish Water Vapor Ablation System in treating patients with intermediate-risk prostate cancer (PCa).

Utilizing transurethral ultrasound and electromagnetic guidance, the Vanquish system enables convective ablation of cancerous prostate tissue, according to Francis Medical, the developer of the device.

Preliminary biopsy research has reportedly demonstrated that a single treatment with the Vanquish system eliminated targeted magnetic resonance (MRI) visible intermediate-risk disease in 91 percent of 110 patients at six months.

Francis Medical noted the Vanquish system is currently being evaluated in a prospective multicenter study (VAPOR2) involving 235 patients with intermediate-risk, localized PCa.

"Patients with intermediate risk prostate cancer currently weigh oncologic risk with quality of life in their treatment decision making," said Samir Taneja, M.D., senior vice president of Northwell Health and a VAPOR 2 co-principal investigator. "It is exciting to see FDA clearance of this promising technology, with the early results showing that water vapor may provide an efficacious option for prostate cancer management with lower risk of side effects as compared to conventional therapies."