Device profile of the Ambicor two-piece inflatable penile prosthesis for treatment of erectile dysfunction: overview of its safety and efficacy

• Published in: Expert review of medical devices Vol. 18; no. 1; p. 9
• Main Authors: Simon, Daniel P, Alter, Kevin, Bajic, Petar, Levine, Laurence A
• Format: Journal Article
• Language: English
• Published: England 02.01.2021
• Subjects: Equipment and Supplies; Erectile Dysfunction - physiopathology; Erectile Dysfunction - therapy; Humans; Male; Patient Satisfaction; Penile Prosthesis - adverse effects; Product Surveillance, Postmarketing; Prosthesis Design; Ambicor; penile implant; two-piece penile prosthesis; sexual dysfunction; inflatable penile prosthesis; erectile dysfunction
• ISSN: 1745-2422
• DOI: 10.1080/17434440.2021.1853524

: Erectile dysfunction is one of the most common forms of male sexual dysfunction worldwide. Over the past several decades, the inflatable penile prosthesis has emerged as the gold standard surgical treatment for refractory erectile dysfunction. The vast majority of current penile implants are three-piece inflatable penile prostheses. However, the design of the two-piece inflatable penile prosthesis offers certain advantages for both the patient and surgeon, and may be the preferred penile implant for certain patient populations. : The Ambicor two-piece inflatable penile prosthesis (Men's Health Division, Boston Scientific, Marlborough, MA, USA) was introduced in 1994 by American Medical Systems (Minnetonka, MN, USA, now a subsidiary of Boston Scientific) and received further design improvements in 1998 to address early mechanical issues with the device. Currently, the Ambicor is the only two-piece inflatable penile prosthesis available in the United States. This review article aims to provide an overview of the Ambicor device and summarize the best available clinical data regarding outcomes and safety. : While two-piece devices account for a small minority of current penile implants, the Ambicor should be considered a safe, reliable, and effective option for appropriately selected patients with the advantage of avoiding blind reservoir placement.