Onset Medical Receives FDA Clearance for Urological Access Device

Onset Medical has announced that the FDA has granted clearance to begin marketing the company's Pathway Ureteral Access Device in the U.S.

The primary clinical application for the Pathway Ureteral Access Sheath is to perform ureteroscopy procedures for the removal of kidney stones. The Pathway Ureteral Access Sheath allows minimally invasive ureteral access in a manner that is less traumatic to both the kidney and ureteral tract compared to devices currently in use. By eliminating a number of surgical maneuvers, use of the Pathway may reduce procedural time, surgical expense and patient recovery time.

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. The FDA has previously provided Onset 510(k) clearance to market specific designs of the Pathway Percutaneous Access Sheath for use in nephrostomy procedures.