Becton, Dickinson and Company (BD) announced that its Liverty™ TIPS Stent Graft has received a CE Mark, allowing the device to be sold throughout the European Union. The approval follows positive safety and effectiveness data from the ARCH clinical trial, which will be presented at the Society of Interventional Radiology meeting on April 12 2026.
The Liverty™ TIPS Stent Graft is a next‑generation, adjustable‑diameter stent (6‑10 mm) designed for transjugular intrahepatic portosystemic shunt (TIPS) procedures in patients with portal hypertension. The single‑arm ARCH study demonstrated that the device can be deployed safely and effectively, and the upcoming presentation will provide the first peer‑reviewed evidence of its performance in a real‑world setting.
The CE Mark opens a significant market opportunity. The global portal hypertension treatment market was valued at $4.49 billion in 2024 and is projected to reach $6.5 billion by 2035, growing at a CAGR of 3.4%. The TIPS segment itself is expected to grow at a CAGR of 6.1% through 2033, underscoring the potential for a new, differentiated product in a high‑growth niche.
BD’s interventional portfolio has been a key growth driver for the company. In Q1 FY2026, the BD Interventional segment generated $1.33 billion in revenue, up 5.8% year‑over‑year, and contributed to the company’s overall revenue of $5.25 billion, a 1.6% increase from the prior year. The company’s FY2026 guidance calls for low single‑digit revenue growth and adjusted earnings per share of $12.35–$12.65, reflecting confidence in continued momentum in its core interventional businesses.
The Liverty™ TIPS Stent Graft differentiates itself from competitors such as Medtronic and Boston Scientific by offering an adjustable diameter and a range of stent lengths, giving interventional radiologists greater flexibility during procedures. BD’s leadership has emphasized the company’s focus on interventional therapies as part of its New BD strategy, positioning the device as a strategic addition to its portfolio.
In the United States, the Liverty™ TIPS Stent Graft remains investigational. BD has not yet announced a timeline for FDA approval, but the company’s ongoing clinical data collection and regulatory engagement suggest a future launch in the U.S. market.
The CE Mark approval is a milestone that strengthens BD’s competitive position in the EU, expands its interventional footprint, and adds a new revenue stream in a growing market. The device’s launch aligns with BD’s broader strategy to focus on high‑growth interventional products and to capitalize on the increasing prevalence of liver disease worldwide.
The announcement also coincides with BD’s recent corporate transformation, including the spin‑off of its Life Sciences & Diagnostic Solutions segment and the combination with Waters Corporation. These moves are intended to sharpen the company’s focus on interventional and diagnostic solutions, positioning BD for long‑term growth in high‑margin markets.
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