Safe Medical Design (San Francisco) said that FDA has cleared its Signal Catheter for commercialization in the United States.

The 100% silicone foley catheter features a novel hub design allowing the catheter to reduce excessive balloon pressure in the event the catheter is improperly placed. Each year in the United States there are as many as 500,000 interventions due to trauma from catheter placement, according to a 2012 study published in the Journal of Urology. Catheter complications are often underreported, with some publications estimating there are closer to 500,000 incidences, according to the company.

“This is a monumental shift in a field that has changed very little for the better part of 25 years, despite the over 20 million catheter placements annually in the United States alone,” said CEO David Aaronson, M.D., said in a prepared statement. “Our device, the Signal Catheter, has the potential to protect patients from unnecessary pain and other complications, while also addressing an issue that costs hospitals $184 million annually.”

“The accidental inflation of a traditional catheter in the urethra can cause painful, long-lasting and costly damage to patients,” added Cedars-Sinai Medical Center urologist Maurice Garcia, M.D., Safe Medical Design’s founder. “The data we presented at the 2018 American Urological Association  annual meeting demonstrates that accidental inflation of the catheter’s balloon within the urethra using SMD’s Signal Catheter results in significantly lower intraurethral balloon pressures.”

The company plans to begin distribution as part of its early access program this month.