Argon Medical Devices Earns Clearance for Retrievable Inferior Vena Cava Filter

Plano, Texas-based Argon Medical Devices Inc. has earned 510(k) clearance from the U.S. Food and Drug Administration for its OptionElite retrievable inferior vena cava (IVC) filter with a new over-the-wire delivery technique. This new clearance enables physicians to safely deliver the filter to a patient’s IVC by following the path of a guidewire. The guidewire assists in keeping the filter centered in the IVC upon placement. The over-the-wire technique is a standard of care in many endovascular procedures, but according to the company, OptionElite is the only retrievable IVC filter that can be delivered by passing the filter’s apex over a guidewire.

The device was designed for the prevention of recurrent pulmonary embolism (PE). In the United States alone, PE is the third leading cause of death among hospitalized patients.

“Applying the over-the-wire technique to deliver an IVC filter is a significant development, employing a technique we frequently use during endovascular procedures,” said Munier Nazzal, M.D., chief of vascular and endovascular surgery at the University of Toledo in Ohio. “It gives a physician more control to accurately position the filter during delivery.”

“We remain committed to providing best-in-class products that allow physicians to provide safe and effective therapy to the patients they treat,” said George Leondis, president of Argon. “Among retrievable IVC filters, finding the right combination of features that make a filter easy to deliver, provide stability in the IVC, and make it easy to retrieve, is a key balance that few designs have achieved. Since its launch in the U.S. market the Option Elite has demonstrated that balance and we’re pleased to now offer it to more patients worldwide.”

OptionElite also recently received the CE mark and will begin commercialization in the European Union imminently. Additionally, the company recently received approval from Health Canada and recently began marketing the product in that geography.

Argon Medical Devices makes medical products and devices for interventional radiology, vascular surgery, interventional cardiology, critical care, and oncology procedures.