LeMaitre Vascular, Inc., a Burlington, Massachusetts company, is trying to bring to the American market its endovascular UniFit™ Abdominal Stent Graft. The device has been sold in Europe for several years under the brand name EndoFit Aorto-Uni-Iliac Stent Graft. While endovascular AAA grafts are nothing new, this is another potentially exciting entrant in an increasingly competitive market.
LeMaitre Vascular, Inc. (Nasdaq: LMAT) today announced the first implant in the UNITE Clinical Trial of its UniFit(TM) Abdominal Stent Graft. The procedure was conducted at Emory University in Atlanta, Georgia.
The UNITE pivotal study 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. LeMaitre Vascular intends to enroll 90 patients in up to 14 centers in connection with the UNITE trial. These patients will be followed for at least one year prior to LeMaitre Vascular’s submission to the FDA of an application for premarket approval (PMA), which is prerequisite to commercial sale of the device in the United States. The primary effectiveness endpoint of the study is based on aneurysm exclusion as evaluated through one- year follow-up. The UNITE study compares the safety and efficacy of the UniFit Abdominal Stent Graft against open surgical abdominal aorta repair, because there are currently no aorto-uni-iliac endovascular stent grafts indicated for this use…
The UniFit Abdominal Stent Graft is a single-bodied aorto-uni-iliac stent graft used to treat an aortic aneurysm-a weakening and ballooning of the aorta–through a minimally invasive endovascular procedure. The device’s encapsulated design minimizes the extent to which its stents contact the blood stream or the vessel wall. This design also allows a wider range of stent graft sizes, including tapered and custom grafts, to fit a wider range of patient anatomies than many competing products. The UniFit Abdominal Stent Graft is currently sold in the European Union and a small number of other foreign jurisdictions and is not available for sale in the United States.