FDA Clears ArtVentive EOS™ Vascular Occlusion Device

ArtVentive Medical Group, Inc. has received U.S. FDA clearance for the Endoluminal Occlusion System (EOS™). Designed for use in the peripheral vasculature, the EOS™ offers immediate, complete and total occlusion in arterial and venous settings.

Background

The ArtVentive EOS™ serves as a proprietary technology platform for several major clinical areas, including peripheral and neurological vascular disorders, women’s health (minimally invasive contraceptive and birth control), interventional cardiology, pulmonary and interventional oncology procedures.

The ArtVentive EOS™ is catheter-based, self-expandable and facilitates permanent or temporary occlusion of peripheral body lumens, cavities occurring within the body’s vascular system and organ network. The ArtVentive EOS™ is designed to serve as a safe and reliable alternative to major surgery in certain cases.

Physician comments

“I see the EOS™ device as a potential game changer for physicians and their patients,” said Dr. Anthony Venbrux, Interventional Radiologist at The George Washington University Hospital in Washington, D.C. “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.”

 Company comments

ArtVentive CEO Jim Graham stated, “This is a testament to the hard work and dedication of our entire team. 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 U.S. and additional international markets as we commence our commercialization efforts.”

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

Source: Artventive Medical Group, Inc., Business Wire

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