Irvine, Calif.-based Endologix, Inc. (NSDQ:ELGX) won conditional Investigational Device Exemption (“IDE”) approval from the FDA to begin U.S. clinical trials to evaluate their Ventana renal stent graft system.
Endologix plans to start enrolling patients in trials before the end of this year to evaluate the success of the Ventana system, a stent graft for the endovascular repair of renal aortic aneurysms. It is designed for use with the company’s AFX endovascular system and Xpand rental stent grafts.
"We are delighted to receive the U.S. FDA conditional IDE approval, and are encouraged by the initial positive outcomes with Ventana,“ Endologix President & CEO John McDermott said in a prepared statement. “We look forward to collaborating with the Ventana clinical investigators on the IDE trial and are hopeful to provide a new endovascular therapy for patients with complex aortic aneurysms in the years ahead."
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