Rigicon Launches the Conti® Artificial Urinary Sphincter Systems

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Summary

Rigicon is globally launching two new artificial urinary sphincter models: ContiClassic® Artificial Urinary Sphincter and ContiReflex® Artificial Urinary Sphincter

Press Release

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.

Conti® Artificial Urinary Sphincter Systems offer unique features for the treatment of Urinary Incontinence. ContiReflex® AUS offers sophisticated intra-abdominal pressure regulation via its innovative pressure regulating balloon design.

Conti® Artificial Urinary Sphincter Systems are designed to offer decisive solutions to physiological and mechanical problems faced with conventional AUS systems. Both AUS models are designed to reduce urethral erosion and device fluid-loss, the two most common causes of treatment failure.

Conti® Artificial Urinary Sphincter Systems are available in a wide and new range of cuff sizes to offer the best fit to the patient’s urethral anatomy.

All components of the Conti® Artificial Urinary Sphincter Systems are offered with the HydroShield™ hydrophilic coating, giving the physician freedom to choose the aqueous solution dip of choice.

Additionally, the innovative design of the EasyClick™ Y-connectors will facilitate tandem occlusive cuff placement.

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.

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
  • Medicines
  • Being overweight
  • Changes with age
  • 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]          

[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

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.

About Rigicon

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.

Find out more at www.rigicon.com.

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