FDAnews Device Daily Bulletin

Onset Initiates Clinical Use of Pathway Ureteroscopy Access Device

June 6, 2005

Onset Medical has begun clinical use of its Pathway Ureteral Access Device in the U.S., designed to perform ureteroscopy procedures for the removal of kidney stones and to manage other conditions within the urinary tract in a minimally invasive fashion.

The Pathway Access Technology is a new and different approach to procedures requiring minimally invasive access to remote sites within the body. The Pathway enters the body at a diameter approximately 50 percent of the size of conventional access devices. Once placed in the body, it is expanded, using radial force to create a large internal diameter.

The first patient was successfully treated at Duke University Hospital in Durham, N.C., by Glenn Preminger, professor of urologic surgery and director of the Duke Comprehensive Kidney Stone Center. Onset will now conduct a 30-patient clinical study to assess the superiority of the Pathway compared to conventional ureteroscopy devices. The company received FDA 510(k) clearance to market the Pathway in March 2005.