BD (NYSE:BDX) announced today that it completed the enrollment of the first patient in a trial of its Liverty TIPS stent graft.
Franklin Lakes, New Jersey-based BD’s ARCH FDA investigational device exemption (IDE) study evaluates the safety and effectiveness of Liverty. The global, prospective, multi-center, single-arm clinical study looks at the investigational device in the treatment of complications from portal hypertension.
It will include 175 patients across up to 40 clinical study sites in the U.S. and Europe. The study includes follow-up for all treated patients at various points after treatment, starting at one month and ending at 24 months.
Dr. Ziv J. Haskal enrolled the first patient in the trial in Charlottesville, Virginia.
“The BD Liverty TIPS stent graft gives us the desired flexibility and diameter options needed to tailor TIPS to specific patient needs, to maximize control of their ascites and/or bleeding while limiting encephalopathy and overshunting risks,” said Haskal. “With this investigational device, our hope is we will be able to improve the care and quality of life of patients with portal hypertension.”
More about the BD Liverty TIPS stent graft
TIPS, an intervention therapy, potentially decreases the portosystemic pressure gradient and helps relieve portal hypertension symptoms. Those symptoms include bleeding from the veins in the esophagus and fluid build-up in the abdomen or chest.
BD designed the Liverty TIPS stent graft as a novel, self-expanding, ePTFE encapsulated implant. It features the capability for a tailored expansion in diameter in incremental steps to achieve the desired pressure gradient.
The delivery system that deploys Liverty provides control over each step of stent graft release, according to a news 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,” said Tim Hug, VP and GM of global peripheral vascular disease at BD. “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.”