AURORA | A company with roots in the Fitzsimons Life Science District just received the go-ahead from the FDA to market its product in the United States.
Swan Valley medical Inc. announced in late October that its T-SpeC catheter device received FDA clearance to market, sell and distribute the device around the country. The FDA approval follows similar clearances in Canada, Europe and Australia.
“This is a big milestone,” said Tim Braun, director of marketing communications at the company’s Bigfork, Mont. headquarters.
The company had an engineering office at the Fitzsimons redevelopment Authority’s Bioscience Park Center building at 12635 E. Montview Blvd. for several years before moving its Colorado operations to a production facility in Denver last summer.
Braun said the company has received a slew of requests from hospitals looking to buy the device.
Swan Valley officials have said they hope T-SpeC it will tap a $2 billion market that sees millions of catheter insertions each year.
T-SpeC — which stands for Transurethral Suprapubic Endo-Cystotomy — is used to insert a suprapubic catheter, meaning a catheter that extends from inside the bladder, out through the abdomen, not the typical catheter that drains the bladder using a tube extending from the bladder out the urethra. According to the National Institutes of Health, suprapubic catheters are often used when patients have urinary incontinence, urinary retention or various types of surgery. They can also be used for patients who are paralyzed.
T-SpeC uses an inside-out method to insert the device, going through the urethra and poking a hole from inside the bladder out through the abdomen. From that hole, doctors can insert a catheter into the bladder.
Many catheters are inserted using an outside-in technique, where a doctor pokes a hole into the bladder from outside the abdomen. But Swan Valley officials say that technique can be risky because if the doctor misses the bladder, they could puncture other nearby organs, including the intestines.
Company officials have also said the device is unique because it is disposable, meaning there is no risk of infection from improperly cleaned devices.
Ronald E. Zook, president and CEO of Swan Valley, said the approval means the company’s technology can quickly get into the hands of urologists.
“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,” he said in a statement. “We are very excited to be able to share this advancement with the US medical community.”