BD Enrolls First Patient in Liverty TIPS Stent Graft IDE Trial

BD (Becton, Dickinson and Company) has enrolled the first patient in its ARCH investigational device exemption (IDE) study. The ARCH IDE study will evaluate BD’s Liverty TIPS (Transjugular Intraheptic Portosystemic Shunt) stent graft to treat complications from portal hypertension.
 
Cirrhosis of the liver can lead to portal hypertension, which is increased pressure in the veins in the esophagus and fluid buildup in the abdomen or chest. The interventional TIPS therapy is intended to decrease the portosystemic pressure gradient and help relive those symptoms.
 
The investigational Liverty TIPS stent graft is a self-expanding, ePTFE encapsulated implant that can provide tailored expansion diameter in incremental steps, in order to achieve the desired pressure gradient. It’s deployed from a delivery system that offers control over each step of stent graft release.
 
“The BD Liverty TIPS Stent Graft is part of our larger effort to work closely with our physician partners to develop and deliver innovations that simplify this complex and time-consuming procedure,” Tim Hug, VP and GM of global peripheral vascular disease at BD, told the press. “Similar to our BD Liverty TIPS Access Kit, the BD Liverty TIPS stent graft is also designed to provide the implanting physician a greater level of control in order to optimize procedural efficiency.”
 
The ARCH study will enroll 175 patients at up to 40 U.S. and European study sites. Follow up will we performed at various points after treatment, from one month to 24 months.