FRAMINGHAM, Mass. FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Guardian Urethral Sheath and Investigational Device Exemption (IDE) approval to begin the SUCCESS Clinical Trial. The SUCCESS Clinical Trial, the third prospective, multicenter, randomized clinical trial for the Solace Bladder Control System, will evaluate the safety and effectiveness of the system in 20 sites throughout the United States.
“We are delighted with our progress with the FDA. We are encouraged by the patient outcomes with the Solace Bladder Control System in previous and ongoing clinical studies, and we look forward to working with the FDA to bring this breakthrough technology to the 15 million women with SUI in the United States.” said Bill Gruber, President and CEO for Solace Therapeutics. “Women need cost-effective treatment alternatives for SUI that don’t require surgery and are reversible at any time.”
About SUI and the Solace Bladder Control System
SUI, the most prevalent form of incontinence among women, affects an estimated 140 million women worldwide. SUI is defined as the inability of the bladder to store urine during normal everyday physical activities without sudden increases in bladder pressure.
The Solace Bladder Control System is a non-surgical alternative to involuntary urinary leakage. The Solace Bladder Control Balloon is a small, lightweight device that floats within the urinary bladder. The balloon is designed to eliminate or reduce involuntary urinary leakage. It acts as a “shock absorber” to reduce the temporary pressure changes in the bladder that cause urinary leakage.
The Solace Bladder Control Balloon procedure is performed in the physician’s office. No fasting, medication or preparation is required before the procedure. The physician places the Solace Bladder Control Balloon into the bladder through the Guardian Urethral Sheath. Pressure reduction is immediate. The balloon can be removed at any time.
The Solace Bladder Control System, which consists of the Solace Bladder Control Balloon, Guardian Urethral Sheath and delivery and removal devices, received the CE Mark. Enrollment is complete in a randomized, controlled, post-market study in Europe.
Please visit www.stopsui.com for more information on the Solace Bladder Control System.
About the Guardian Urethral Sheath
The Guardian Urethral Sheath is a device used to simplify access into the bladder through its natural orifice, the urethra. The sheath permits delivery and removal of the Solace Bladder Control Balloon and can also be used during any routine cystoscopic procedure. The sheath includes a protective barrier designed to reduce introduction of bacteria into the urinary tract that can occur during routine urological procedures.
About Solace Therapeutics Inc.
Solace Therapeutics is dedicated to developing innovative, non-surgical and clinically effective devices that address unmet needs in lower urinary tract symptoms (LUTS). Our initial focus is on improving the quality of life for women whose daily life is disrupted by their incontinence. The company’s venture capital investors include New Enterprise Associates and Spray Venture Partners. Please visit www.solacetx.com to learn more about Solace Therapeutics, Inc.