August 11, 2023 – BD announced the enrollment of the first patient in the investigational device exemption (IDE) study, “ARCH.” The study is a global, prospective, multi-center, single-arm clinical study for the treatment of complications from portal hypertension, assessing the safety and effectiveness of the investigational BD Liverty™ TIPS Stent Graft.
More than 100 million people are living with some form of liver disease in the US, including cirrhosis. Cirrhosis can lead to portal hypertension, which is increased pressure within the veins that drain the liver. Common symptoms of portal hypertension are bleeding from veins in the esophagus and fluid build-up in the abdomen or chest. The creation of a TIPS is an interventional therapy aimed at decreasing the portosystemic pressure gradient and helping to relieve those symptoms.
The investigational BD Liverty™ TIPS Stent Graft is a novel, self-expanding, ePTFE encapsulated implant with the capability for a tailored expansion diameter in incremental steps to achieve the desired pressure gradient. It is deployed from a delivery system that provides control over each step of stent graft release.
The ARCH Study will include 175 patients at up to 40 clinical study sites across the United States and Europe. Follow-up for all treated patients will be performed at various points after treatment — starting at one month and ending at 24 months.