FDA Clears Hydrophilic Silicone Catheters

Rochester Medical Corp. (Stewartville, MN) has received FDA clearance to market its newly developed hydrophilic silicone catheters. The company received clearance for its hydrophilic intermittent catheters, Foley catheters, and suprapubic urine drainage catheters.

The hydrophilic surface of these catheters becomes very slippery when wetted providing an extremely low friction surface.

"This essentially friction free surface will allow us to produce catheters that are extremely easy to insert and remove, and which should maximize comfort and minimize urethral irritation for patients using catheters," said Anthony J. Conway, Rochester president and CEO.

"The inherent advantages of silicone over latex and other materials will now be further enhanced by the new surface," Conway added. "In particular, patients who must intermittently catheterize themselves multiple times per day will find this hydrophilic surface on silicone to be extremely attractive."

The company also noted that, as previously announced, it continues to work toward an agreement with Maersk Medical for the sale of its standard silicone Foley private label business.

Edited by Ursula Jones