ArtVentive Medical Group announced that it has received US Food and Drug Administration (FDA) clearance for its 11mm Endoluminal Occlusion System (EOS).
Designed for use in the peripheral vasculature, the ArtVentive EOS offers immediate and complete vessel occlusion in arterial and venous settings.
The ArtVentive EOS is a catheter-based, self-expandable device, which facilitates permanent and immediate occlusion of peripheral vessels.
It is designed to serve as a safe and reliable alternative to major surgery in certain cases.
"We are excited to introduce the 11mm EOS device to the U.S. market. This important new size allows interventional radiologists to treat larger vessels with precision and reliability," said Dr. Leon Rudakov, President of ArtVentive.
"With the introduction of the 11mm EOS device, ArtVentive expands its clinical reach treating vessels from 3mm to 11mm in diameter, and meets physician expectations for a device capable of occlusion in these larger diameter vessels."
"We are proud to be at the forefront of such growing innovation, providing doctors the most advanced technology to effectively treat vascular diseases, stated Jim Graham, ArtVentive Chief Executive Officer.
"The EOS technology platform serves unmet clinical needs and provides a foundation for future innovation with the potential to address other clinical conditions. We look forward to expanding our market reach within the US, as well as internationally."
ArtVentive Medical Group with corporate headquarters in Carlsbad, California, is an innovative, multi-faceted medical device company focused on developing, manufacturing and marketing globally a family of devices featuring the ArtVentive EOS.