Liverty™ TIPS Stent Graft

^* As of October 2026.

ARCH Study, a prospective, multi-center, single arm study of the Liverty™ TIPS Stent Graft. The primary safety endpoint was Freedom from Major Complications through 30 days post index procedure, which included device- and/ or procedure-related serious adverse events. Analyzed on a pre-specified basis, the primary safety endpoint result was 85.8% (151/176, p-value 0.4341), which did not meet the pre-defined performance goal of 85%. Analyzed on a post-hoc basis, where Grade 1 and Grade 2 hepatic encephalopathy events resolved by medical therapy alone were counted as successes, Freedom from Major Complications through 30 days post index procedure was 94.3% (166/176, p-value <0.0001). The primary effectiveness endpoint, Freedom from Shunt Dysfunction through 6 months post treatment completion was 90.4% (113/125, p-value 0.0002), compared to a PG of 78%, and was 83.7% (41/49) in 6-7 mm diameter shunts. Shunt dysfunction was defined as both a >50% reduction in stent lumen confirmed by direct shunt venography and a portosystemic gradient exceeding the post treatment completion value. The Intent-to-Treat (ITT) population consists of all participants who have signed the informed consent form and had the Liverty™ TIPS Stent Graft delivery system introduced, regardless of whether the device was implanted or if another device was implanted. The Modified Intent-to-Treat (mITT) population consists of any participants in the ITT population who had only Liverty™ TIPS Stent Graft(s) implanted at Index Procedure. Participants will be followed through 24 months. Data on file. BD. Tempe, AZ.  

Indications for Use: The Liverty™ TIPS Stent Graft is indicated for the treatment of complications of portal hypertension.  

Select Warnings: When placing a shunt with a final diameter of ≤8 mm, the leading 20 mm of the covered stent graft segment must be additionally dilated with an 8 mm balloon for at least 25 seconds to help reduce the risk of thrombosis. · Potential allergens: This device contains nitinol, an alloy made of nickel and titanium, tantalum and tungsten. · If multiple stent grafts are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol (nickel-titanium alloy)). · The potential benefits of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure should be carefully weighed against the potential risks. Consult clinical practice guidelines to identify special considerations for patients with pre-existing conditions, including, but not limited to: Congestive heart failure or severe cardiac valvular insufficiency; Elevated right or left heart pressure; Severe or moderate pulmonary hypertension.  

Select Precautions: The stent graft implant cannot be repositioned after complete deployment of the covered stent graft segment. · A stent graft which is misplaced and extends too far into the vena cava or portal vein may cause thrombosis and/or difficulties during liver transplant surgery. · The covered segment of the stent graft should line the entire parenchymal tract and hepatic vein to the hepatocaval junction. Inadequate coverage of the hepatic vein may lead to stenosis in an unlined hepatic vein segment. · The stent graft must not be post-dilated beyond 10 mm diameter. · Wait for 7 days after placement of the Liverty™ TIPS Stent Graft before performing surveillance ultrasound assessment of the shunt because air in the pores of the ePTFE may provide inaccurate information about the shunt patency.  

Potential Complications may include, but are not limited to: Cholestasis; Congestive heart failure; Embolism; Hemoperitoneum; Hepatic encephalopathy; Hepatic infarction; Liver failure/dysfunction; Peritonitis; Recurrence of Ascites; Renal failure. 

BD-180810