BrightWater Medical Announces FDA Approval of ConvertX Biliary Stent System as a Minimally Invasive Alternative for Biliary Obstruction Treatment

VCBeat (WeChat Official Account: vcbeat) learned from foreign media that on March 25 (U.S. local time), BrightWater Medical, based in Mountain View, California, announced that its ConvertX Biliary stent system had received FDA approval. The system is indicated for the treatment of severe biliary obstructions, including a range of complications in patients following gastric bypass surgery or liver transplantation, such as sepsis, biliary cirrhosis, and liver injury.

BrightWater Medical is a medical device company primarily serving radiologists by providing them with medical devices for treating ureteral obstructions in patients. The company was founded by Dr. Bob Smouse, Professor of Radiology and Surgery at the University of Illinois College of Medicine. Dr. Smouse has over twenty years of extensive experience in radiology, clinical medicine, and endovascular surgical research. BrightWater Medical is currently developing the ConvertX Biliary biliary stent system, which will be integrated into radiology-related procedural workflows.

ConvertX Biliary is the first percutaneous plastic biliary stent system designed for interventional radiologists, serving as an alternative to invasive surgical procedures for treating biliary obstruction. This system reduces the costs and time associated with secondary interventions during procedures, enabling stent placement or deployment in under one minute. It eliminates the need for stent exchanges and obviates the requirement for patient sedation or repeated insertion attempts.

It is worth noting that the ConvertX Biliary Stent System is part of BrightWater Medical’s ConvertX stent portfolio, which also includes the company’s innovative ConvertX Nephroureteral Stent System. Approved by the FDA for the treatment of ureteral obstruction, this system can replace secondary invasive interventional procedures in patients with severe ureteral blockage.

Biliary obstruction causes bile to flow from the liver and gallbladder through the pancreas into the duodenum. The obstruction may be caused by tumors, gallstones, lymph node enlargement, biliary stricture, and other factors. If biliary obstruction is not treated promptly, severe complications may arise, such as infection, sepsis, biliary cirrhosis, or liver damage.

Currently, the primary method for treating biliary obstruction is ERCP (Endoscopic Retrograde Cholangiopancreatography). Physicians use an endoscope to place a stent via the patient’s mouth and stomach, thereby opening the obstructed bile duct and restoring normal bile flow. However, this treatment presents several inconveniences. First, the stent placement procedure can take up to one hour, and patients are required to carry an external drainage bag after the procedure. Furthermore, two weeks after discharge, once the hepatic puncture site has healed, a second surgical intervention is necessary to replace the drainage tube with a stent.

Fortunately, the ConvertX Biliary System developed by BrightWater Medical avoids many of the drawbacks associated with ERCP. The ConvertX Biliary System not only eliminates the need for patients to undergo two separate procedures but also enables the placement of ConvertX Biliary temporary stents in patients who were previously considered unsuitable for ERCP treatment. While traditional therapies for biliary obstruction are performed by gastroenterologists, the ConvertX Biliary System allows radiologists to participate in the intervention, thereby optimizing the management of biliary obstruction.

Dr. Saher S. Sabri, Chief of Radiology at MedStar Washington Hospital Center, stated: “Previously, we treated these severe biliary obstructions without appropriate medical tools. The introduction of ConvertX Biliary represents a significant shift, allowing us to place it in patients with both benign and malignant biliary obstructions. This facilitates treatment via less invasive procedures and reduces radiation exposure for both patients and staff.”

Dr. Bob Smouse led the development of ConvertX Biliary, stating, “In accordance with the American College of Radiology (ACR) practice guidelines, the ConvertX Biliary temporary stent is equipped with eight out of nine optional devices for biliary obstruction. Physicians can perform stent interventions without requiring additional training.”

BrightWater Medical was founded in 2011 and completed a $5.2 million Series A financing round led by OSF Ventures on May 24, 2016.

(Compiled by Wang Chan)