Bigfork, Montana, October 31, 2012 – Swan Valley Medical, Incorporated, a medical device company focused on development and manufacturing of innovative medical instruments, announced today that the company’s T-SPeC® (Transurethral Suprapubic endo-Cystostomy) Surgical System received the U.S. Food and Drug Administration (FDA) clearance to market, sell and distribute in the United States. The company has previously received ISO 13485 Certification, CE Mark Clearance, Health Canada Certification and the TGA Australia Registration. The Company is currently marketing in the E.U. through its independent distribution partners and expects to immediately develop the U.S. market.
The T-SPeC® Surgical System, available in two models, was developed to allow placement of suprapubic catheters in patients with a range of body sizes by initiating the surgical procedure from inside the bladder under controlled guidance. Suprapubic catheterization is typically utilized by physicians as a long-term catheterization solution to facilitate drainage of urine from the bladder for patients with spinal cord injuries, or under treatment for urinary retention and severe chronic incontinence.
The current industry standard is a blind percutaneous needle punch catheterization method that is associated with clinical reports of death and life-threatening injuries, presenting significant risks to patients1. “The engineering and thought that has been built into the T-SPeC® is outstanding. To be able to place the suprapubic catheter in such a fast, simple, precise way, is remarkable. It will easily be adopted by Urologists everywhere,” said Larry Karsh, MD, Director, The Urology Center of Colorado Clinical Research Department and Swan Valley Medical, Incorporated Medical Advisory Board member.
“This is a major milestone that our team has been focused on since the inception of the company,” said Ronald E. Zook, President & CEO of Swan Valley Medical, Incorporated. “The FDA clearance represents a global landmark in allowing our innovative T-SPeC® technology to benefit hundreds of thousands of patients here in the U.S., as well as, currently being available to over 27,000 international urologists. We are very excited to be able to share this advancement with the U.S. medical community.”
About Swan Valley Medical, Incorporated:
Founded in 2006, Swan Valley Medical, Incorporated, is a medical device company initially focused on development and commercialization of sophisticated urological surgical instruments incorporating new approaches combined with new technologies to enhance and improve upon existing surgical devices and procedures. The Company is based in Bigfork, MT, with R&D and manufacturing offices in Denver, CO. The Company is currently developing its E.U. sales channels and actively marketing its T-SPeC® Surgical System in the E.U. through its distribution partners. More information about the Company can be found at www.swanvalleymedical.com.
The T-SPeC® Surgical System has undergone over 6 years of research and testing. The instrument enables surgeons to place a suprapubic urinary catheter by initiating the surgical procedure from inside the bladder under controlled guidance, thereby offering surgeons an alternative to blind percutaneous needle punch catheterization methods or the highly invasive open procedures that require hospitalization and long patient recovery time. The T-SPeC® is available in two model sizes to allow treatment of patients with a range of body sizes and abdomen thicknesses. Now, suprapubic catheterization can be efficiently addressed with the Company’s T-SPeC® Surgical System with a ten minute, same-day-outpatient, minimally invasive procedure. To learn more, visit www.swanvalleymedical.com.
1 Ahluwalia RS, e. a. The surgical risk of suprapubic catheter insertion and long-term sequelae. The Royal College of Surgeons of England – Urology. 2006; (88): 210-213