Author: Rigicon, Inc.

Rigicon proudly announces the publication of a clinical study article titled “Short-term revision rate of Rigicon Testi10™ testicular prosthesis in adolescents and adults: a retrospective chart review” in the International Journal of Impotence Research.

The study evaluated the safety and reliability of Rigicon’s Testi10™ in 427 patients, including 382 adults and 45 adolescents, who underwent implantation between February 2019 and August 2023 by 132 physicians from 45 centers in 26 countries.

The Kaplan-Meier calculation of survival from removal or revision was an impressive 99.8% for all patients at 54 months of follow-up.

The study highlights the generally safe nature of testicular prosthesis implantation and the very rare incidence of revision surgery required for Rigicon Testi10™.

Testicular prosthesis implantation is a valuable solution for the physical, cosmetic, and psychological challenges associated with testicular loss, which can affect males of any age due to conditions such as congenital issues, undescended testes, tumors, torsion, infection, or trauma.

With this publication, Rigicon reinforces its commitment to innovation and improving the quality of life for patients through the development of advanced prosthetic urology solutions backed by clinical research.

About Testicular Prosthesis 

A testicular prosthesis is a medical device used to simulate the appearance and feel of one or both testicles after they have been surgically removed due to conditions such as cancer, trauma, or congenital anomalies.

This device is an option when non-surgical treatments or the use of externally worn prosthetics are not desirable or effective.

The testicular prosthesis is designed to replicate the weight, shape, and texture of a natural testicle, enhancing cosmetic appearance and psychological well-being. It is typically made from silicone, which is inert and biocompatible, minimizing the risk of rejection or allergic reactions.

The testicular prosthesis is considered a safe and effective option for patients seeking to restore the appearance of their testicles after surgery. It is the preferred method for addressing the aesthetic concerns related to an empty scrotum and can be customized to match the size and firmness of the remaining natural testicle if present.

About Rigicon

Rigicon specializes in the research, development, and manufacturing of innovative prosthetic urology solutions, with 30 years of experience in urology. Rigicon continues to introduce cutting-edge technologies that improve patient outcomes and enhance the quality of life for those suffering from urinary conditions, including erectile dysfunction and urinary incontinence. Rigicon’s commitment to innovation and patient care continues to redefine industry standards and improve the quality of life for patients globally.

The new HL-LEVINE Combo Prosthesis Tool represents Rigicon’s commitment to innovation via collaboration with global physician partners.  Dr. Huseyin Luleci and Dr. Laurence Levine, both world-renowned prosthetic urology surgeons, worked together to create this innovative combination surgical tool.  The surgical tool is a combination HL dilator tool and the traditional Furlow instrument both used for penile implant surgery. This new tool was designed to help facilitate better patient outcomes by decreasing operating time and eliminating the need to switch between the Furlow and HL dilator during the implant procedure.

“By merging these two key devices, the HL-LEVINE Combo Prosthesis Tool brings enhanced efficiency and simplicity to urological surgery,” said Dr Luleci. “This is an important leap forward in making complex procedures more manageable and, importantly, reducing the patient’s time in the operating room.”

According to Dr. Levine “the HL-Levine Combo Prosthesis Tool facilitates easier dilation and penile implant insertion, helping to minimize potential surgical complications and promote better postoperative outcomes. By leveraging the design features of the two individual tools, the HL-LEVINE Combo Prosthesis Tool provides an innovative new option for surgeons to utilize during implant procedures.

About Erectile Dysfunction

Erectile Dysfunction, or ED, is the inability to achieve or sustain an erection suitable for sexual intercourse. ED is 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 implants 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’ of experience in Prosthetic 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.

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 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.

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.