BD (Becton, Dickinson) has announced the US commercial launch of its BD Liverty transjugular intrahepatic portosystemic shunt (TIPS) stent graft. According to the company, the next-generation TIPS system is designed to give physicians greater flexibility to tailor treatment for patients with portal hypertension.
In a recent press release, the company details that the system is intended to offer deployment accuracy and control, and to allow treatment to be tailored to individual patient anatomy, disease progression and clinical goals. The device enters the US market with established clinical and physician experience in Europe. It is supported by six-month interim results from the prospective, multicentre ARCH clinical study, which enrolled 177 patients. BD describes ARCH as the first and only investigational device exemption (IDE) study with clinical data on small TIPS diameters (6–7mm).
“The Liverty TIPS stent graft was designed to give physicians more flexibility during TIPS procedures,” said Rob Righi, vice president and general manager of the Vascular Platform, Peripheral Intervention at BD. “By offering the longest length TIPs stent graft on the market and tailored shunt diameter sizing, the system helps physicians make real-time treatment decisions for patients with complications of portal hypertension.”
The stent graft has an expandable diameter of 6–10mm to address patient-specific haemodynamics, and covered stent lengths of 4–10cm, which BD says are the longest commercially available. It uses a fully sheathed, tri-axial delivery system designed for deployment accuracy, control and ease of use. Highly visible radiopaque markers and a marker band aid visualisation and placement under fluoroscopy, and the delivery system allows sheathless tracking through the liver parenchyma.
Ziv Haskal, principal investigator of the ARCH trial and professor of radiology and surgery at the University of Virginia, Charlottesville, USA said: “I’ve helped develop a lot of existing TIPS technology. Device innovation is intended to advance every operator’s daily expertise. What stands out using the Liverty TIPS stent graft is the unique ease of delivering the device into position and controlling it during deployment. The ability to accommodate the new range of intended TIPS diameters and longer lengths will help physicians best tailor treatment to each patient.”
With US commercial availability, the Liverty TIPS stent graft expands BD’s interventional portfolio and reinforces the company’s commitment to advancing treatment options for patients with complications of portal hypertension.
