Solace Therapeutics Inc. won CE Mark approval in the European Union for its intravesical system to treat female stress urinary incontinence.
The Framingham, Mass.-based medical device maker said its device is a small, quarter-sized balloon that floats inside the bladder. Inserted via catheter during an out-patient procedure, the balloon is designed to relieve the pressure fluctuations within the bladder that lead to incontinence.