The company has also obtained Investigational Device Exemption (IDE) approval to begin the Success clinical trial designed to evaluate the safety and effectiveness of its Solace bladder control system, a non-surgical alternative to involuntary urinary leakage.
Success clinical trial is the third prospective, multicenter, randomized clinical trial for the Solace bladder control system and will be conducted at 20 sites in US.
Solace Therapeutics president and CEO Bill Gruber said that the company is delighted with its 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 US," Gruber added.
The Guardian urethral sheath permits delivery and removal of the Solace bladder control balloon and can also be used during any routine cystoscopic procedure.
With a protective barrier, the sheath reduces introduction of bacteria into the urinary tract that can occur during routine urological procedures.
The Solace bladder control system is a small, lightweight device that floats within the urinary bladder. The CE Marked-device consists of the Solace bladder control balloon, Guardian urethral sheath and delivery and removal devices.
The Solace bladder control balloon eliminates or reduces involuntary urinary leakage. Acting as a shock absorber, the device reduces the temporary pressure changes in the bladder that cause urinary leakage.
The Solace bladder control balloon is placed into the bladder through the Guardian urethral sheath. Pressure reduction is immediate and the balloon can be removed at any time.
