BrightWater Medical, a mid-stage medical device company focused on radiology, has received clearance from the US Food and Drug Administration (FDA) for its ConvertX Biliary Stent System to treat biliary obstructions.


Image: US FDA has cleared the BrightWater Medical’s ConvertX biliary stent system. Photo: Courtesy of The U.S. Food and Drug Administration/Wikimedia.

The medical device company said that the patients with severe duct blockages or gastric bypass or liver transplant patients may either undergo two separate one-hour interventional procedures for stent placement or a drain placement instead, depending on the affordability for the procedures.

Biliary obstructions may be caused by tumors, gallstones, enlarged lymph nodes, cysts or strictures and the treatment procedure involving a drain placement requires the drain to be exchanged with a new one for every two to three months.

The company clams that its new ConvertX System forms the first system to provide a percutaneous plastic biliary stent option for interventional radiologists and it has designed the system to eliminate the need for the second invasive procedure and the associated risk, cost, and time.

BrightWater Medical said that instead of a drain-to-stent exchange, its ConvertX System itself facilitates stent release in less than one minute during an in-office visit or at bedside without the need for sedation or repeated drain insertions.

Washington Hospital Center director of interventional radiology and professor of radiology at MedStar Georgetown University Hospital Saher Sabri said: “Before this, we have had to treat these serious cases without having the right tools.

“The ConvertX is a significant paradigm change that enables the IR 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.”

Interventional Radiologists treat biliary obstructions that are more severe or anatomically challenging, like in patients with gastric bypass or liver transplants, through two separate one-hour interventional procedures for stent placement.

BrightWater Medical said that the new ConvertX Biliary Stent System is part of its ConvertX stent family that comprises FDA cleared innovative ConvertX Nephroureteral Stent System for treatment of ureteral obstructions.

ConvertX Nephroureteral Stent System allows the radiologists to eliminate a second invasive interventional procedure in treating patients with severe ureteral blockages.

BrightWater Medical founder and CEO and professor of radiology & surgery at the University of Illinois, College of Medicine Bob Smouse said: “The Biliary Stent System was designed by IRs for IRs. It is simple to use and deliver with standard interventional techniques and does not require additional physician training.

“Before the ConvertX, the absence of a percutaneous plastic stent was a huge product gap in the device armamentarium of the IR. According the ACR Practice Guidelines1, a temporary plastic stent is the device-of-choice in 8 out of 9 bile duct blockages and now the IR has that stent option.”