ArtVentive Medical Receives FDA Clearance for Endoluminal Occlusion System

Carlsbad, Calif.-based ArtVentive Medical Group Inc. has received U.S. Food and Drug Administration (FDA) clearance for the Endoluminal Occlusion System (EOS). The technology is designed for use in the peripheral vasculature, to offer immediate, complete and total occlusion in arterial and venous settings. It is intended for use in challenging embolization cases.

The system is comprised of an implantable occlusion device and a delivery catheter. According to ressults from the first in-human clinical trail last year, the acute occlusion rate at the end of the procedure was 100 percent in nine out of of nine vessels. The spermatic veins of all patients remained occluded on venography at 30 days follow-up. Pain scores related to varicoceles decreased in five of six patients.

“I see the EOS device as a potential game changer for physicians and their patients,” said Anthony Venbrux, M.D., interventional radiologist at the George Washington University Hospital in Washington, D.C., who led the study. “In my experience with the device, it has shown immediate and complete vascular occlusion upon deployment. The use of this new endovascular technology assures the operator that they have stopped blood flow at the treatment site. This creates an opportunity for shorter procedure times and less radiation exposure to patients and staff in addition to lower medical costs.”

“This is a testament to the hard work and dedication of our entire team,” said ArtVentive CEO Jim Graham. “The EOS technology platform serves unmet clinical needs and provides a foundation for future innovation to expand into additional treatment areas. We look forward to sharing the technology with physicians in the United States and additional international markets as we commence our commercialization efforts.”

“We are excited to introduce the EOS device into the U.S. market,” said Leon Rudakov, Ph.D., president of ArtVentive. “We are expanding our case experience in Europe and anticipate further positive acceptance in the U.S. and global markets.”

EOS is ArtVentive’s core offering, and aims to develop a family of devices based on the platform.