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.
RONKONKOMA, N.Y., May 8, 2023 /PRNewswire-PRWeb/ -- New Study by Renowned Experts Confirms Safety and High Satisfaction Rates of 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.
Rigicon, a leading medical device company based in New York, specializes in the research, development, and manufacturing of innovative urological solutions. 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.
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.
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 study revealed a mean follow-up of 24.2 months (range: 7-36 months) and a mean patient age of 56.23 years. The mechanical failure rate was 2.24%, while explantation due to patient dissatisfaction was 0.19%. Additionally, the study reported a 0.19% rate of both Peyronie's failed correction and infection, and a 0.37% rate of component displacement. The survival analysis of the device at 12, 24, and 36 months showed a respective 96.6%, 97.8%, and 96.8% rate until surgical intervention was needed.
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. Rigicon's continued dedication to advancing urological solutions, coupled with the positive results from this study led by renowned experts, paves the way for improved patient care and quality of life.
Media Contact
Jessica Miranda, Rigicon,Inc., 1 8882029790, [email protected]
SOURCE Rigicon,Inc.
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