The FDA approved the ConvertX Biliary Stent System for the treatment of biliary obstructions, according to a press release from BrightWater Medical.
The ConvertX Biliary Stent System was designed to provide interventional radiologists with a percutaneous plastic biliary stent option that enables stent release in less than 1 minute during an in-office visit or at bedside. It also eliminates the need for the second invasive procedure and its associated risks, cost and time.
“Before this, we have had to treat these serious cases without having the right tools,” Saher S. Sabri, MD, director of Interventional Radiology at MedStar Washington Hospital Center, said in the release. “The ConvertX is a significant paradigm change that enables the [investigational radiologist] to be involved in percutaneous temporary plastic stent placement for benign and malignant biliary disease. It allows us to treat with one less invasive procedure for the patient, reducing radiation exposure for the patient and staff.”
The ConvertX Stent product line was featured at the Advanced Interventional Management Symposium in New York City in November 2018 as the lead presentation during the “New and Innovative Technologies” section.
“It is simple to use and deliver with standard interventional techniques and does not require additional physician training,” Bob Smouse, MD, founder and CEO of BrightWater Medical and ConvertX System developer, said in the release. “Before the ConvertX, the absence of a percutaneous plastic stent was a huge product gap in the device armamentarium of the [investigational radiology].”