Indiana medical device giant Cook Medical announced the launch of a new clinical study, the 1st of its kind evaluating the safety and effectiveness of its Zilver Vena venous self-expanding stent.
The VIVO study will enroll select adult patients experiencing limiting leg pain, leg swelling or skin discoloration or a healed or active lower leg ulcer, according to a Cook statement.
Researchers will assess the safety and efficacy of the device at 1 year following treatment, with additional follow-up through 3 years following implantation
"This is an important trial which is intended to objectively assess the endovenous correction of symptomatic iliofemoral vein stenosis with a stent designed for this specific purpose," co-lead investigator Dr. Anthony Comerota said in prepared remarks. "It is a privilege to be a part of this crucial prospective trial."
The VIVO trial will enroll up to 243 patients from 30 participating sites in the U.S. and in the Asia-Pacific region, Cook reported. The study is the 1st of its kind in the U.S. to assess treatment with an iliofemoral venous stent, co-lead investigator Dr. Lawrence "Rusty" Hoffman noted, adding that he is "looking forward to the study initiation."
Cook Medical has made strides with its Zilver line of stents, winning premarket approval in November 2012 for the Zilver PTX stent, making it the 1st drug-eluting stent approved by the FDA for treatment of peripheral artery disease.