New Study Confirms Safety and High Satisfaction Rates of Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis for Erectile Dysfunction Treatment


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.


Release Date: May 8, 2023


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