Argon Medical Devices, Inc. says it has received FDA clearance to begin marketing 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.
Last April we covered the launch of Argon’s OptionELITE retrievable IVC filter. With this new FDA clearance the company can now offer the same device, but with the added benefit of guidewire assistance to keep the filter centered in the IVC upon placement. The over-the-wire technique is a standard of care in many endovascular procedures, yet this new clearance means the OptionELITE is the only retrievable IVC filter that can be delivered by passing the filter’s apex over a guidewire.
Argon also announced that it would begin marketing the OptionELITE in Europe following the device’s recent CE Mark approval. Additionally, the company recently received approval from Health Canada and recently began marketing the product in that geography.
“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 of 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.”
Source: Argon Medical, Inc., PR Newswire