LeMaitre Vascular Receives IDE Approval To Begin 'Unite' UniFit Abdominal Stent Graft Pivotal Study
LeMaitre Vascular announced that it has received approval from the United States Food and Drug Administration for an investigational device exemption supplement to conduct its UNITE Aorto-Uni-Iliac Stent Graft Clinical Trial.
This 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 had previously received conditional FDA approval for its IDE supplement.
"Although we had initiated two study sites based upon conditional approval, many other hospitals, though eager to participate, have been waiting for the FDA to remove conditions. We expect that this new approval will help us drive enrollment through a broad range of study sites," said George W. LeMaitre, the company's Chairman, President and CEO. "We believe surgeons need a singled-body aorto-uni-iliac stent graft to help combat aneurysmal disease and we are excited to begin implanting devices in our pivotal study."
LeMaitre Vascular intends to enroll 90 patients in up to 14 centers. These patients must be followed for at least one year prior to LeMaitre Vascular's submission to the FDA of an application for PMA approval. 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 the primary treatment of aorto, aorto-iliac, and/or iliac aneurysms.
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 prevents its stents from contacting the blood stream or the vessel wall. This design 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.
The FDA's IDE approval applies only to the investigational use of UniFit Abdominal Stent Grafts that have been sterilized with ethylene oxide gas, a relatively common means of sterilizing medical devices. LeMaitre Vascular also sterilizes its UniFit Abdominal Stent Grafts sold outside the United States with hydrogen peroxide, a newer and generally faster means of sterilizing medical devices. Hydrogen peroxide sterilization enables the more rapid production of customized stent grafts. LeMaitre Vascular intends to continue to work with the FDA to resolve their questions regarding this method of sterilization with the intent of ultimately seeking PMA approval of the hydrogen peroxide-sterilized UniFit Abdominal Stent Graft.