Gore's enrolls the 1st patient in a clinical trial of its Excluder iliac branch devices in treatment of patients with common iliac artery aneurysms.
W.L. Gore & Associates this week enrolled its 1st patient in a study of its Excluder iliac branch devices, evaluating the implants in treatment of common iliac artery aneurysms or aorto-iliac aneurysms.
The prospective, multi-center, non-randomized, single-arm study is designed to assess the safety and effectiveness of the devices, in conjunction with the Excluder AAA endoprosthesis, as it isolates the common iliac artery from systemic blood flow and preserves blood flow in the external iliac and internal iliac arteries.
The 1st patient was treated at St. Anthony's Medical Center, in St. Louis, Missouri, Gore said.
"Providing the best possible patient care and fulfilling unmet clinical needs require constant innovation. Gore is committed to advancing these innovations through collaboration with the clinical community," Aortic Business Unit Leader Ryan Takeuchi said in prepared remarks. "We are excited that endovascular specialists globally are expressing such a high level of interest in the study and in iliac artery repair solutions."
The Newark, Del.-based company won CE Mark approval in the European Union for its Excluder iliac branch stent graft. Gore also landed pre-market approval from the FDA for its 25cm Viabahn stent graft.
The FDA asks medical device manufacturers to submit documentation about controls they have in place...
Medical device and pharmaceutical companies paid out $3.5 billion to doctors and hospitals during the...
Endo International agrees to settle as many as 20,000 lawsuits filed in U.S. courts against its...
Acutus Medical secured $26.2 million in new funding for its cardiac mapping technology.