OptionELITE retrievable over-the-wire delivery technique enters new markets with receipt of FDA clearance.
Argon Medical Devices Inc. received clearance from the U.S. Food and Drug Administration (FDA) to begin marketing the 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 and the OptionELITE is the only retrievable IVC filter that can be delivered by passing the filter's apex over a guidewire.
"Applying the over-the-wire technique to deliver an IVC filter is a significant development, employing a technique we frequently use during endovascular procedures. It gives a physician more control to accurately position the filter during delivery," said Dr. Munier Nazzal, chief of vascular and endovascular surgery at the University of Toledo.
"We remain committed to providing best-in-class products that allow physicians to provide safe and effective therapy to the patients they treat," stated George Leondis, president, Argon Medical Devices. "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 OptionELITE has demonstrated that balance and we're pleased to now offer it to more patients worldwide."
Argon Medical Devices Inc. also announced that the company will begin marketing the OptionELITE in Europe following the device's recent approval for the CE mark. Additionally, the company recently received approval from Health Canada and recently began marketing the product in that geography.
The OptionELITE retrievable inferior vena cava (IVC) filter was designed by Rex Medical LP for prevention of recurrent pulmonary embolism (PE). In the United States alone, PE is the third leading cause of death among hospitalized patients. With these approvals and subsequent launches, more patients worldwide who require PE protection now have access to the benefits of the OptionELITE IVC filter.
Source: Argon Medical Devices