RONKONKOMA, N.Y. (PRWEB) May 07, 2020
Rigicon announces that ContiClassic® Artificial Urinary Sphincter and the ContiReflex® Artificial Urinary Sphincter models have recently received CE Mark Approval and is initially available in all major European markets.
ContiClassic® Artificial Urinary Sphincter and ContiReflex® Artificial Urinary Sphincter are implant devices that treat Urinary Incontinence (UI). Conti® Artificial Urinary Sphincter Systems are indicated to treat urinary incontinence due to intrinsic sphincter deficiency in cases such as incontinence following prostate surgery. Conti® Artificial Urinary Sphincter Systems are designed to restore the function of the normal (healthy) urinary sphincter that restricts urine flow out of the bladder.
Global roll-out of Conti® Artificial Urinary Sphincter Systems will continue through-out 2020.
A multi-center clinical trial, “Evaluation of the Rigicon Conti® Artificial Urinary Sphincter Systems for the Treatment of Patients with Urinary Incontinence (ERASE UI)”, is scheduled for 2020 Q4.
A.Melih Luleci (VP, Global Operations) added, "Rigicon will continue to expand its offering in prosthetic urology market. We are targeting to launch Conti® Artificial Urinary Sphincter Systems and Infla10® Inflatable Penile Prosthesis in the US market around 2022/Q3."
About Urinary Incontinence
Urinary incontinence (UI) is the involuntary loss of urine. Patients suffering from Urinary incontinence are unable to control the release of urine from the bladder. While Stress Urinary Incontinence is the most common type, there are different types of urinary incontinence. Stress urinary incontinence is the unexpected leakage of urine when an outside pressure occurs with activities such as heavy lifting, coughing, sneezing, laughing, or exercise. This outside pressure causes the already weakened bladder to leak urine.
Weakened urinary sphincters may be caused by: Surgery in the pelvic area or the prostate, injury to the urethra, medicine, being overweight, changes with age and other causes Urinary incontinence is a significant problem, affecting tens of millions of patients. UI is estimated to affect 1 out of 10 males, with increasing prevalence associated with aging. Men with Urinary Incontinence have a higher rate of depression and are more likely to decrease participation in activities (e.g., decrease work hours, change employment, or take voluntary early retirement)1
The majority of patients who experience weekly urinary incontinence do not seek care for it. Many who sought treatment believe that none was provided and many who received treatment continue to have troubling symptoms.2
About Artificial Urinary Sphincter
Artificial Urinary Sphincter (AUS) is a medical device specifically designed to treat urinary incontinence.
Artificial Urinary Sphincter is a surgical treatment option when non-surgical or behavioral treatment options fail.
AUS will mimic the role of a healthy urinary sphincter (the two muscles controlling the exit of urine from the bladder through the urethra) AUS will close the urethra preventing urine leakage. The patient will squeeze a pump located in his scrotum to release the cuff over the urethra and void. The cuff will return to its closed state in around 2 minutes to prevent urine leakage after voiding. The artificial urinary sphincter is widely regarded as the gold standard for the treatment of Urinary Incontinence.
Rigicon, Inc. designs and manufactures innovative urological implants with a keen focus on creating a comprehensive product portfolio and a commitment to deliver high quality and innovative urology products for patients and physicians all over the world.
1 Irwin DE, Milsom I, Kopp Z, Abrams P, Cardozo L., “Impact of overactive bladder symptoms on employment, social interactions and emotional well-being in six European countries” BJU International. 2006;97:96–100.
2 Harris S.S., Link C.L., Tennstedt S.L., “Care seeking and treatment for urinary incontinence in a diverse population”, J Urol. 2007;177:680–684