TEMECULA, Calif.--(BUSINESS WIRE)--BrightWater Medical, Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s innovative ConvertX® Biliary Stent System for treatment of biliary obstructions. The biliary ducts carry bile from the liver and gallbladder to the small intestine. Patients with severe duct blockages or difficult anatomies – such as gastric bypass or liver transplant patients -- face serious complications including infection, sepsis, biliary cirrhosis or injury to the liver.

Today, most of these patients will either need to undergo two separate one-hour interventional procedures for stent placement or if considered poor candidates for the staged stent procedure, undergo a drain placement instead. If the biliary blockage is managed with a drain, the drain must be exchanged for a new one every 2-3 months, for life.

The ConvertX System is the first system to provide interventional radiologists with a percutaneous plastic biliary stent option. The system is designed to eliminate the need for the second invasive procedure and the associated risk, cost, and time. 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.
“Before this, we have had to treat these serious cases without having the right tools,” explained Saher S. Sabri, MD, Director of Interventional Radiology at MedStar Washington Hospital Center and Professor of Radiology at MedStar Georgetown University Hospital. “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.”

Biliary obstructions may be caused by tumors, gallstones, enlarged lymph nodes, cysts or strictures. IRs treat biliary obstructions that are more severe or anatomically challenging, such as in patients with gastric bypass or liver transplants, through two separate one-hour interventional procedures for stent placement.

“The Biliary Stent System was designed by IRs for IRs,” explained ConvertX System developer Bob Smouse, M.D., founder and CEO of BrightWater Medical and Professor of Radiology & Surgery at the University of Illinois College of Medicine. “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.”

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