MINNEAPOLIS, April 23, 2015 /PRNewswire/ -- Coloplast, a leading medical device company, announced it has received approval from The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for changes in labeling of the Titan Inflatable Penile Prosthesis (IPP) instruction for use to incorporate ectopic reservoir placement. This approval is the first of its kind, and gives prosthetic surgeons a new, alternative surgical method for men undergoing IPP placement.
"This FDA approval reinforces Coloplast's commitment to prosthetic urology and advancing the surgical technique of prosthetic surgery," said Eric Halvorson, Coloplast Global Vice President and General Manager, Urology Care. "The clinical community expressed a need for ectopic reservoir placement, and can be confident about using the new surgical procedure with our innovative product."
Impact on the Clinical Community
Peer-reviewed publications supporting the new procedure indicate that 90% of high-volume prosthetic surgeons believe placing the reservoir in an ectopic location can be advantageous for patient safety1. In addition, Abdominal Wall/ATF (Anterior to Tranversalis Fascia) placement of an IPP reservoir is seen as a relatively simple technique that can avoid the possibility of catastrophic complications associated with traditional retroperitoneal reservoir placement1.
"Catastrophic bowel, bladder and vascular injuries related to inflatable penile implant reservoir placement can be tragic for everyone involved in a procedure," explained Dr. Paul Perito, Chief of Surgery at Coral Gables Hospital (Fla.). "Coloplast's efforts to gain approval for urologists to choose abdominal wall reservoir placement over traditional placement in the retropubic space has provided the necessary vehicle to drastically reduce the risk of these catastrophic injuries for patients."
Dr. Allen Morey, Professor, Department of Urology, University of Texas Southwestern Medical Center in Dallas (Texas), added, "Reservoir placement has long been one of the primary challenges of prosthetic urology, due to the neighboring vital structures encountered both placing and removing reservoirs deep in the pelvis. The submuscular abdominal wall reservoir location offers a safe alternative strategy with reduced risk of injury to surrounding pelvic organs. We have found submuscular abdominal wall placement to be well tolerated by patients and easy to teach and perform."
Improving Patient Life
The new surgical treatment option is an advantageous development for patients considering an IPP to help manage erectile dysfunction (E.D.). Approximately 30 million men suffer from E.D.2, and nearly one in every four men over sixty-five will experience some degree of the condition3. Coloplast's Men's Health products put men back in charge by restoring reliability and spontaneity to their lives and relationships.
"Coloplast delivers solutions for those with intimate healthcare needs – we work very closely with the people who use our products improve their quality of life," said Halvorson.
The Titan family of IPPs represents the next generation of innovation, and are designed to emulate the look and performance of a natural erection. These products have been developed in Coloplast's long standing tradition of listening and responding to customers, offering a dependable method of restoring sexual function.
For more information on the newly approved abdominal wall placement procedure for the Titan IPPs and other solutions that are available to treat E.D., visit www.coloplastmenshealth.com.
Danish medical device company Coloplast develops products and services designed to make life easier for people with very personal and private medical conditions. We start by listening to our users to better understand their needs, and then respond by bringing the best ideas to market in the form of medical devices and service solutions. Coloplast's businesses include ostomy care, urology care, continence care, and wound and skin care. With the development of a strong portfolio of new products and investments in a professional sales force, Coloplast now employs more than 8,500 people worldwide. In 2013, Coloplast received global recognition for having the best corporate reputation among patients (PatientView).
About Coloplast Surgical Urology
Coloplast Urology produces a range of surgical devices to help people who suffer from urological disorders such as erectile dysfunction (E.D.), urinary incontinence, weak pelvic muscles, kidney stones and enlarged prostates. We have two focus areas: Female Pelvic Health and Men's Pelvic Health. Both are dedicated to developing devices that can make life easier for people suffering from intimate urological disorders. Coloplast is in continuous dialogue with surgeons and nurses to improve less invasive surgical therapies for male and female incontinence. We are always working to constantly improve our products and streamline other surgical implant procedures.
To learn more about Coloplast, visit www.us.coloplast.com.
1. Doron S. Stember, MD, Bruce B. Garber, MD, and Paul E. Perito, MD. Outcomes of Abdominal Wall Reservoir Placement in Inflatable Penile Prosthesis Implantation: A Safe and Efficacious Alternative to the Space of Retzius. J Sex Med 2014;11:605–612
3. NIH Publication No. 09-3923. June 2009.