New Technology is Game-Changer for Suprapubic Catherization
BIGFORK, Montana and KITCHENER Ontario, Canada, Swan Valley Medical, Incorporated, together with St. Mary’s General Hospital announced that the T-SPeC® Surgical System was used in its first live human clinical cases on August 15, 2012, for the treatment of chronic urinary retention and to evaluate patient comfort and improved safety. Dr. Blair Egerdie, M.D., Vice President Medical Affairs, assisted by Dr. Larry Karsh, M.D.,Director, The Urology Center of Colorado Clinical Research Department and Swan Valley Medical, Incorporated Medical Advisory Board Member, placed suprapubic catheters by performing a Transurethral Suprapubic endo-Cystostomy (T-SPeC®) in these patients using the patented, new technology of the T-SPeC® Surgical System. This new instrument and technology utilizing an inside-out (transurethral-initiated) procedure was performed on four patients, of which three presented with neurogenic bladders, one was an MS patient, all had chronic bladder retention, two presented with urethra erosion, and one patient had a constricted bladder due to previous radiotherapy. The clinical procedures were administered through St. Mary's General Hospital in Kitchener Ontario, Canada on August 15, 2012. The Company’s CEO, Ronald Zook noted, “These live patient procedures represent another major milestone for our Company by continuing to validate the performance of our instrument outside the previous successful cadaver testing…”
The T-SPeC® procedure was performed on these patients all of whom have normal Body Mass Index (BMI), thus the T-SPeC® model T7 was used for all four procedures. Swan Valley Medical has also developed the T-SPeC® model T14 thereby offering physicians greater versatility with their clinical decision-making when treating patients with a variety of abdominal sizes/thicknesses. This model was designed to accurately create a surgical pathway up to a 14 cm abdominal thickness as commonly seen in obese and morbidly obese patients. The T-SPeC® T14 model is the world’s first instrument developed to enable the use of the suprapubic catheterization procedure for the morbidly obese patient in a minimally invasive way, allowing for same day surgery on an outpatient basis, without the use of an open procedure requiring post-op hospitalization. Egerdie was very pleased with the performance, ease of use and quickness of the procedures performed using the T-SPeC®. Egerdie explained, "I am very impressed with the T-SPeC® device. It converts a 2-3 day hospital stay, open operation, on very fragile patients, to a five-minute outpatient procedure. Its ease of use will enable all Urologists to rapidly adopt the technique to their surgical practice." The average duration of the first four procedures was under 5 minutes. Typically, using other standard SPC methods, the procedures would have taken twenty minutes or more to complete, creating additional stress on patients. Egerdie is preparing to perform additional cases in the upcoming weeks.
Swan Valley Medical developed the T-SPeC® Surgical System in response for the need of a faster, safer and more effective procedure than that of the current percutaneous trocar punch methods routinely used for SPC, the current industry standard. The "percutaneous punch needle" devices have documented reports of perforation of the Peritoneum Cavity and puncture of bowel, thereby resulting in high morbidity and patient mortality reported in several studies. Attempts to place an SPC in a patient with a neurogenic bladder or patients with BMI over 27 are extremely difficult and provide additional risk by attempting to puncture the bladder with a needle from outside the body. The innovative design of the T-SPeC® was developed as an SPC alternative by providing the point of incision from within the bladder (starting at the target), cutting up, out and away from the Peritoneum, bowel, rectum, and reproductive organs which are subject to penetration using other outside-in procedures. “The T-SPeC® will dramatically change the lives of patients who have chronic catheters and fulfills an unmet need in the healthcare industry. Just the ability to perform this procedure on an obese patient, alone, where currently there is no device out there, will be a game-changer.” Karsh explained. Egerdie and Karsh, using the T-SPeC® Surgical System administered a precise placement of all four suprapubic catheters. The ability to view the precise location of the exit track of the cutting blade was extremely beneficial to Egerdie, "This simple instrument will provide a revolutionary new way to care for patients. It's a safe departure from the standard procedure and has the potential to create new hope for patients by eliminating the trauma and embarrassment of insertion and removal of urethral catheters by family members or other caregivers." Karsh agreed that he sees the benefit to patients, the surgeon and the hospital where the T-SPeC® could become a standard of care when considering the placement of a suprapubic catheter. Karsh continued, “The engineering and thought that has been built into the T-SPeC® is outstanding. To be able to securely connect the catheter, unlike the Lowsely device, and place the suprapubic tube in such a fast, simple, precise way, is remarkable. It will easily be adopted by Urologists.”
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 has received ISO 13485 Certification, CE Certification, Health Canada and TGA Australia Registration thereby permitting the Company to place the T-SPeC® instruments into the European, Canadian and Australian marketplaces. More information about the Company can be found at www.swanvalleymedical.com.
The T-SPeC® Surgical System has undergone over 6 years of development and testing. The T-SPeC® Surgical System is available in two models and was developed to enable treatment of urinary retention and severe chronic incontinence in patients with a range of body sizes. The instrument enables surgeons to place a suprapubic urinary catheter by initiating the surgical procedure from inside the bladder under controlled guidance. Prior to use, the Company supplies detailed training materials and information needed for use of the T-SPeC® in a clear and concise manner. The steps of the procedure for using the T-SPeC® device are clearly defined and accompanied with anatomical representations which make the use of the instrument simple to visualize. To learn more, visit www.swanvalleymedical.com.
With international premarket regulatory clearances in-place, the company is developing international distribution networks through independent medical device distributors in Europe, Canada, and Australia. With those clearances in place, the Company is currently selling the T-SPeC® Surgical System to the approved international markets. In addition, the T-SPeC® Surgical System is currently being reviewed via a section 510(k) Notification by the U.S. Food and Drug Administration (FDA) for marketing clearance in the United States. The Company anticipates the completion of the FDA regulatory review in September, 2012.
Director of Marketing Communications