Stent system for biliary obstructions gains FDA clearance

BrightWater Medical, a medical device company based in Temecula, California, announced that its new stent system for treating biliary obstructions has gained FDA approval.

The ConvertX Biliary Stent System was developed to save patients with severe duct blockages from undergoing two separate interventional procedures; with the system, they only undergo one procedure. The stent can also be drained during office visits in less than one minute.

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

“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 in Washington, D.C., said in the same statement. “The ConvertX is a significant paradigm change that enables the interventional 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.”