Tactra™ Malleable Penile Prosthesis has been launched in the United States for the treatment of erectile dysfunction (ED), a condition that affects more than half of men over 40.1 The new penile prosthesis is the first new innovation in penile implants from Boston Scientific in more than 10 years and represents an evolution in the design of malleable penile implants to offer the patient and his partner a more authentic, natural feeling erection.
Boston Scientific received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Tactra Penile Prosthesis on April 16, 2019.
The device is currently available in the United States and is expected to be available in Europe, Canada, Latin America, Asia Pacific and Saudi Arabia later this year.
Boston Scientific notes the Tactra Penile Prosthesis utilizes natural feeling dual-layer silicone and includes a Nitinol core to optimize comfort, rigidity and durability for effective penetration and concealment.The easy-to-use implant is manually lifted up for intercourse and manually pushed down when not in use.
With 69,000 new U.S. penile implant candidates a year2, patients have varying needs and goals when it comes to ED treatment. The Tactra Penile Prosthesis provides urologists with another option to offer patients, particularly those with limited dexterity, and may allow them to treat more ED patients who are appropriate for a penile prosthesis.
Mohit Khera, MD, MBA, MPH, professor of Urology, Baylor College of Medicine said: “The technological improvements in the Tactra Penile Prosthesis have allowed for a durable, natural-feeling erection with a device that is easier for surgeons to implant and allows for more patient comfort,” said Dr. Mohit Khera, MBA, MPH, professor of Urology, Baylor College of Medicine. “This device will expand the number of patients with ED that we can treat via penile prosthesis.”
Dave Pierce, senior vice president and president, MedSurg, Boston Scientific added, “The U.S. launch of the Tactra Penile Prosthesis is another example of how Boston Scientific continues to innovate to meet the needs of physicians and their patients to improve overall patient care,” said Dave Pierce, senior vice president and president, MedSurg, Boston Scientific.
1 Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61.
2 U.S. incidence rate from Dymedex AMS Men’s Health – select market questions 28 MAR 2014.