FDA clears BrightWater Medical biliary stent system

The U.S. Food and Drug Administration (FDA) has cleared the BrightWater Medical ConvertX^® Biliary Stent System for treatment of biliary obstructions, according to the Temecula, CA-headquartered company. BrightWater said that this is the first temporary stent cleared by the FDA for sale in the United States.

The ConvertX System provides interventional radiologists with a percutaneous plastic biliary stent option and is designed to eliminate the need for the second invasive procedure. Rather than a drain-to-stent exchange, the ConvertX System itself enables stent release in less than one minute during an in-office visit or at bedside without the need for sedation or repeated drain insertions.

In a press release, BrightWater stated that the binary stent system was designed by interventional radiologists, and is simple to use and deliver with standard interventional techniques. It also does not require additional physician training.

The ConvertX Biliary Stent System is part of BrightWater Medical’s ConvertX Stent Family, which includes the company’s innovative ConvertX Nephroureteral Stent System cleared by the FDA for treatment of ureteral obstructions. That system enables the IR to eliminate a second invasive interventional procedure in treating patients with severe ureteral blockages.