FDA approves Francis Medical's water vapor ablation treatment for prostate cancer

The U.S. Food and Drug Administration (FDA) has granted clearance for Francis Medicals Vanquish system, designed to treat intermediate-risk prostate cancer. Vanquish utilizes a transurethral approach, guided by ultrasound and electromagnetic technology, to deliver thermal ablation through water vapor, targeting cancerous prostate tissue.

This approval follows results from Francis Medicals U.S.-based VAPOR 2 trial (NCT05683691), which assessed the safety and effectiveness of Vanquish in patients with localized Gleason Grade Group 2 (GGG2) prostate cancer. Data from the study showed that, after six months, 91% of the 110 patients with MRI-visible intermediate-risk disease were free of targeted cancer following a single Vanquish treatment.

Francis Medical reports that Vanquish can treat cancerous areas throughout the prostate, overcoming a limitation seen in other ablative therapies. Importantly, no serious device-related adverse events have been recorded in the study.

Mike Kujak, CEO of Francis Medical, stated that FDA clearance allows for a treatment option that carefully balances cancer control with quality of life. He added that the company will continue monitoring VAPOR 2 participants as it seeks to establish Vanquish as a first-line therapy that is effective against cancer yet gentle on patients.

Prostate cancer remains the most frequently diagnosed cancer among men in the U.S., affecting approximately one in eight men during their lifetime. AdvaMed, the Advanced Medical Technology Association, praised the FDA decision, highlighting that increased access to innovative medical technologies like Vanquish is crucial for enhancing patient care.

In the UK, prostate cancer is the most common cancer in men and second overall after breast cancer. Public awareness has increased following high-profile cases, including former Olympian Sir Chris Hoy and former Prime Minister David Cameron.

Despite this, the UK National Screening Committee recently advised against widespread prostate cancer screening, citing concerns over over-diagnosis and minimal reduction in mortality.

Author: Sophia Brooks