LeMaitre eyes US market with UniFit abdominal stent graft trial:
This article was originally published in Clinica
Moving its single-body aorto-uni-iliac stent graft closer to the US market, LeMaitre Vascular has begun a pivotal FDA-approved clinical trial of the product. The study - UNITE - will evaluate the safety and effectiveness of the company's UniFit abdominal stent graft in the treatment of aorto, aorto-iliac, and/or iliac aneurysms. It is expected to enrol 90 patients in up to 14 centres. Patients will be followed-up for at least one year, after which the Burlington, Massachusetts firm hopes to file a premarket approval application (PMA) for permission to sell the device in the US. UniFit is currently sold in Europe and in a small number of other countries.