BD’s Liverty TIPS Device for Treatment of Portal Hypertension to Be Studied in ARCH

August 10, 2023—BD (Becton, Dickinson and Company) announced the enrollment of the first patient in ARCH, an investigational device exemption study assessing the safety and effectiveness of the BD Liverty transjugular intrahepatic portosystemic shunt (TIPS) stent graft for the treatment of complications from portal hypertension.

The investigational Liverty TIPS stent graft is a self-expanding, expanded polytetrafluoroethylene-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. TIPS interventional therapy is aimed at decreasing the portosystemic pressure gradient and helping to relieve those symptoms, noted the company.

According to BD, the global, prospective, multicenter, single-arm ARCH clinical 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 1 month and ending at 24 months.

The first patient in ARCH was enrolled by the study’s global principal investigator, Ziv J. Haskal, MD, Professor and Vice Chair, Department of Radiology and Medical Imaging/Interventional Division, University of Virginia School of Medicine in Charlottesville, Virginia.

“The BD Liverty TIPS stent graft gives us the desired flexibility and diameter options needed to tailor TIPS to specific patient needs, to maximize control of their ascites and/or bleeding while limiting encephalopathy and overshunting risks,” commented Dr. Haskal in the company’s press release. “With this investigational device, our hope is we will be able to improve the care and quality of life of patients with portal hypertension.”