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Comprehensive Study Highlights Rigi10TM Malleable Penile Prosthesis Safety Outcomes Implanted Worldwide

The clinical study, titled “Safety Outcomes of the First Rigi10 Malleable Penile Prostheses Implanted Worldwide” provides a comprehensive evaluation of the safety of the Rigi10 Malleable Penile Prosthesis.

This study underscores the device’s status as a reliable solution for patients seeking treatment for erectile dysfunction (ED). Conducted between March 2019 and December 2022, it encompassed the participation of 605 first-time patients who were implanted with the Rigi10 by 46 high-volume, experienced implanters in 15 countries.

Survival calculations were performed at 12 months, 24 months, and 36 months, yielding Kaplan-Meier statistical survival curves with survival rates of 98.8%, 98.9%, and 99.2%, respectively. The device offers an efficient solution for addressing ED while ensuring exceptional safety and patient contentment. In this study, Rigi10 MPP was successful in treating ED in 603 out of 606 patients (99.5%). The paucity of revision operations was remarkable.

Compared to its competitors, notable features of Rigi10 include the supple bending capacity of its rods, simplifying implantation through a smaller corporotomy, and the availability of extra widths of rods that facilitate precise penile girth attainment. Support for this is evident in the study, which indicates that the 12 mm cylinder size, not offered by competitive devices, was the second most used cylinder width.

Rigi10’s safety was convincingly demonstrated; according to the results, Rigi10 MPP had no mechanical malfunctions, and the risk of prosthesis erosion (0.17%), infection (0.33%), or patient dissatisfaction (0.49%) was quite low. Less than 1% of all implants required reoperation for any reason.

The Rigi10 MPP, introduced in 2019, is a sterile, trimmable, and single-use implant that consists of two rods available in two lengths and six different widths, along with extender tips. The rods have stainless-steel wires, which are quite flexible, improving concealability under the patient’s clothing. The Rigi10 provides the required rigidity, comfort, and discretion to patients with ED.

Rigicon remains dedicated to advancing the field of prosthetic urology and providing patients with a safe and effective option for addressing ED. This study underscores Rigicon’s unwavering commitment to these goals.

About Erectile Dysfunction

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

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

About Malleable Penile Prosthesis

A malleable penile prosthesis is a medical device that allows an impotent patient 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 rods reside in the penis on either side. No tissue is removed to place the rods; the rods simply occupy spaces previously filled with blood when one was potent. The rods do not disrupt the flow of urine or ejaculate, and they do not alter the sensation of the penis. 

About Rigicon

Rigicon specializes in the research, development, and manufacturing of innovative prosthetic urology solutions, with 30 years of experience in urology. We focus on creating a comprehensive product portfolio for urologists 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: November 9, 2023