BD launches expandable liver shunt stent graft in the U.S.

Overview

Updated 1 hour ago

BD began selling a liver shunt device in the U.S. that lets physicians choose the shunt's diameter during the procedure, from 6 to 10 millimeters. The Liverty is the first TIPS system with clinical data on 6-7 mm shunts, the sizes tied to the lowest risk of the procedure's worst side effect.

TIPS, short for transjugular intrahepatic portosystemic shunt, treats portal hypertension by creating a new channel through the liver. Bigger shunts control blood pressure better but let more blood bypass the liver, raising the risk of hepatic encephalopathy, a toxin-driven confusion that can progress to coma. BD's ARCH trial of 177 patients found no severe encephalopathy cases in people with 6-7 mm shunts, a result that could reshape how physicians size TIPS.

Why it matters

A shunt that starts small and enlarges only when needed could cut the encephalopathy that has limited TIPS for decades.

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Key Indicators

90.4%

Freedom from shunt dysfunction at 6 months

Primary efficacy endpoint of the ARCH trial, meeting the 78% performance goal.

177

Patients in the ARCH trial

177 patients across 26 centers in the U.S., France, and Germany.

100%

Technical success rate

176 of 176 shunt creations succeeded in the trial.

Severe encephalopathy in 6-7mm shunts

No grade 3+ hepatic encephalopathy cases among patients with the smallest shunts.

6-10mm

Expandable shunt diameter range

Physicians can post-dilate the device to any size within this range during the procedure.

Voices

Curated perspectives — historical figures and your fellow readers.

People Involved

Dr. Ziv Haskal

Principal investigator of the ARCH trial

Professor of radiology and surgery at the University of Virginia

Rob Righi

Vice president and general manager, Vascular Platform, Peripheral Intervention at BD

Leads BD's interventional portfolio including the Liverty launch

Organizations Involved

BD (Becton, Dickinson and Company)

Medical technology company

Manufacturer and U.S. distributor of the Liverty TIPS Stent Graft

Global medical technology company headquartered in Franklin Lakes, New Jersey.

Bard Peripheral Vascular, Inc. (BPV)

Device manufacturer (BD subsidiary)

PMA applicant for the Liverty TIPS Stent Graft

BD subsidiary that submitted the premarket approval application for the Liverty.

U.S. Food and Drug Administration

Federal regulatory agency

Approved the Liverty via premarket approval on September 25, 2026

The FDA's Center for Devices and Radiological Health reviewed the ARCH study and approved the device.

Timeline

2026 October 2026

3 events Latest: Today

October 2026
BD announces U.S. commercial launch
Today Launch

BD began selling the Liverty in the U.S., citing the ARCH study and European experience as supporting evidence.
Today
September 2026
FDA approves the Liverty TIPS Stent Graft
Regulatory

The FDA granted premarket approval under PMA P250050 for treatment of complications of portal hypertension.
September 25th, 2026
2026
ARCH trial six-month results presented
Clinical Data

Investigators presented 90.4% freedom from shunt dysfunction, no severe encephalopathy in 6-7mm shunts, and 100% technical success.
2026

Scenarios

Guidelines Adopt Small-Diameter TIPS as Initial Standard

Likely Resolves by End of 2028

Discussed by: Interventional radiology and hepatology guideline committees, including AASLD and SIR

If real-world adoption of the step-up approach matches trial outcomes, major liver disease and interventional radiology societies could update guidance to recommend starting with 6-7 mm shunts and enlarging only if pressures require. The ARCH data showed lower encephalopathy rates with small shunts and comparable clinical success for ascites control (84.8% in small-shunt patients). A guideline shift would cement the approach as the default for TIPS creation.

Rival Adjustable TIPS Device Reaches U.S. Market

Possible Resolves by End of 2029

Discussed by: Competing device manufacturers including W.L. Gore (Viatorr)

The leading TIPS device maker, W.L. Gore, and others may develop competing expandable-diameter systems. FDA approval of a rival device within three years would validate the small-shunt paradigm and show competitive response to BD's first-mover advantage in the U.S. Gore's Viatorr has held the covered TIPS market since the mid-2000s and would likely respond to protect share.

Post-Market Data Reveals Higher-Than-Expected Complication Rates

Possible Resolves by Q2 2028

Discussed by: FDA review documents and interventional radiology literature

The FDA approval summary noted thrombosis in small shunts during the trial that led to a protocol change requiring pre-dilation of the leading covered section with an 8 mm balloon. If real-world operators skip this step or encounter complications in more complex patients, post-approval studies or MAUDE reports could show higher complication rates than the trial. That would slow adoption and prompt additional training requirements.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

Early 2000s

Covered TIPS stents replace bare metal (2000s)

Polytetrafluoroethylene-covered TIPS stents, led by Gore's Viatorr, replaced bare metal stents for transjugular intrahepatic portosystemic shunts. Bare metal stents clogged from tissue overgrowth within months; the ePTFE lining improved patency dramatically but locked the shunt at a fixed 10 mm diameter.

Then

Shunt patency improved sharply, reducing the need for repeat interventions to keep shunts open.

Now

The covered stent became the standard TIPS device, but the fixed diameter left physicians unable to tailor shunt size to individual patients.

Why this matters now

The Liverty carries the covered-stent design forward and adds adjustable diameter, the next step in the same iterative improvement that covered stents began.

Late 1980s

TIPS procedure introduced (late 1980s)

German interventional radiologists developed the transjugular intrahepatic portosystemic shunt as a minimally invasive alternative to surgical portosystemic shunting for portal hypertension. The procedure creates a new channel between the portal and hepatic veins to decompress the liver's blood flow.

Then

TIPS spread worldwide through the 1990s as a treatment for variceal bleeding and refractory ascites.

Now

TIPS became standard care but the fixed shunt size and encephalopathy risk limited broader use, particularly in patients with milder liver dysfunction.

Why this matters now

The Liverty's adjustable diameter directly targets the encephalopathy limitation that has constrained TIPS since the procedure's introduction.