Author: admin2024

A recent study conducted by esteemed prosthetic urology implanters Steven K. Wilson (CA, USA), Mariano Rossello (Spain), Pedro Maria (NY, USA), and Lexiaochuan Wen (MA, USA) has shown promising safety outcomes and high patient satisfaction rates for the Infla10 Three-Piece Inflatable Penile Prosthesis (Rigicon, New York) as a treatment option for patients with erectile dysfunction who have not responded to conservative therapies or prefer a definitive solution.

The study included 535 patients who underwent Infla10 implantation between June 2019 and April 2022, with 103 surgeons from 26 centers participating. Patients were followed up to evaluate the safety of the device, with factors such as revision/explantation, reoperation for infection, mechanical failure, and medical reasons being recorded. Statistical analysis was performed using SPSS 25.0 (IBM, US) and Kaplan Meier survival statistics.

The Infla10 Three-Piece Inflatable Penile Prosthesis features a new-generation hydrophilic coating on all external surfaces, including the reservoir, which allows for compatibility with various antibiotics tailored to the patient’s needs. This innovative design has contributed to the positive results observed in the study.

These findings further demonstrate the safety and effectiveness of the Infla10 Three-Piece Inflatable Penile Prosthesis, solidifying its position as a reliable treatment option for patients with erectile dysfunction.

About Erectile Dysfunction

Erectile Dysfunction, or ED, is the inability to achieve or sustain an erection suitable for sexual intercourse. ED is actually a common male sexual disorder and may maintain a permanent course as some men cannot have any erection for the remaining part of their life. ED might have a deep impact on the quality of life and social relationships of the patient.

ED may be basically caused by various diseases and disorders including heart disease, diabetes, pelvic area damage due to surgery, accidents or radiation therapy, benign prostatic hyperplasia (BPH, which is non-cancerous enlargement of the prostate tissue), disorders associated with low testosterone levels, Parkinson’s disease, and other neurologic diseases.

About Inflatable Penile Prosthesis (Three–Piece Inflatable Penile Prosthesis)

Inflatable devices, the most common type of penile implant used, can be inflated to create an erection, and deflated at other times. Three-piece inflatable implants use a fluid-filled reservoir implanted under the abdominal wall, a pump and a release valve placed inside the scrotum, and two inflatable cylinders inside the penis. (Source: Mayo Clinic)

Penile implant surgery is considered a gold standard therapy for men with erectile dysfunction.

About Rigicon

Rigicon specializes in the research, development, and manufacturing of innovative urological solutions with 30 years’ experience on Urology. We focus on creating a comprehensive product portfolio for urologist(s) around the world. Committed to improving the quality of life for patients, Rigicon focuses on providing cutting-edge treatments that address various urological conditions, including erectile dysfunction and urinary incontinence.

Rigicon is globally launching two new artificial urinary sphincter models: ContiClassic Artificial Urinary Sphincter and ContiReflex Artificial Urinary Sphincter. Rigicon announces that the ContiClassic Artificial Urinary Sphincter and the ContiReflex Artificial Urinary Sphincter models have recently received CE Mark Approval and are 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 external urethral 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. The global roll-out of Conti Artificial Urinary Sphincter Systems will continue throughout 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

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.

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References

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

Rigicon, Inc. announces that the U.S. Food and Drug Administration (FDA) has cleared Rigi10 Malleable Penile Prosthesis for implantation into the corpora cavernosa of the penis for men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse.

Rigi10 is easy to implant and easy to use. The Flexible Rod Technology™ enables higher bending angles with no spring-backs. Rigi10 is offered in 5 different diameters and 2 sizes for a better fit to the patient’s anatomy.

Infla10 is the next-generation inflatable penile prosthesis designed with years of experience in urology. Infla10 incorporates a hydrophilic coating on all external component surfaces to facilitate rapid and strong absorption of the solution on the device and promote easier device implantation. Innovative Rapid-Pump™ mechanism offers greater ease and speed for patients when inflating and deflating the prosthesis. Infla10 AX version offers the patients anatomical girth and length expansion addressing concerns regarding post-operative penile shortening.

Penile Prosthesis is for treating erectile dysfunction, a condition affecting more than 200 million men annually worldwide, with nearly 50% of men over 60 suffering from moderate to severe symptoms.[1,2]

About Erectile Dysfunction

Erectile Dysfunction, or ED, is the inability to achieve or sustain an erection suitable for sexual intercourse. ED is actually a common male sexual disorder and may maintain a permanent course as some men cannot have any erection for the remaining part of their life. ED might have a deep impact on the quality of life and social relationships of the patient.

ED may be basically caused by various diseases and disorders including heart disease, diabetes, pelvic area damage due to surgery, accidents or radiation therapy, benign prostatic hyperplasia (BPH, which is a non-cancerous enlargement of the prostate tissue), disorders associated with low testosterone levels, Parkinson’s disease, and other neurologic diseases.

About Malleable Penile Prosthesis (Semi-Rigid Penile Prosthesis)

A malleable penile prosthesis is a medical device that allows an impotent male to achieve an erection. The malleable implant consists of two rods that are always hard but pliable. All components are concealed within the body and cannot be seen from the outside. The penile implant cylinders reside in the penis on either side. No tissue is removed to place the rods; the rods simply occupy spaces that were previously filled with blood, when one was potent. The rods do not disrupt the flow of urine or ejaculate. The rods do not alter the sensation of the penis.

About Inflatable Penile Prosthesis (Three-Piece Inflatable Penile Prosthesis)

Inflatable devices, the most common type of penile implant used, can be inflated to create an erection and deflated at other times. Three-piece inflatable implants use a fluid-filled reservoir implanted under the abdominal wall, a pump and a release valve placed inside the scrotum, and two inflatable cylinders inside the penis. (Source:Mayo Clinic)

Penile implant surgery is considered a gold standard therapy for men with erectile dysfunction.

About Rigicon

Rigicon designs and manufactures innovative urological implants with 30 years experience on Urology. We focus on creating a comprehensive product portfolio for urologist(s) around the world. Our commitment is to deliver high quality and innovative urology products to our valued patients and physicians.

[1] US Census Bureau.

[2] Aytac IA et al (1996) – The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJUI, 84: 50-6.e seeking and treatment for urinary incontinence in a diverse population”, J Urol. 2007;177:680–684