Option Elite retrievable vena cava filter receives FDA clearance for a new over-the-wire delivery technique

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Argon Medical Devices announced that it has received clearance from the US Food and Drug Administration to begin marketing the Option Elite retrievable inferior vena cava filter with a new over-the-wire delivery technique on 16 January 2013.

According to the company, this new clearance enables physicians to safely deliver the filter to a patient’s inferior vena cava by following the path of a guidewire. The guidewire assists in keeping the filter centred in the inferior vena cava upon placement. The over-the-wire technique is a standard of care in many endovascular procedures and the Option Elite is the only retrievable inferior vena cava filter that can be delivered by passing the filter’s apex over a guidewire.

“Applying the over-the-wire technique to deliver an inferior vena cava 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 Munier Nazzal, chief of Vascular and Endovascular Surgery at the University of Toledo, USA.

Argon will launch the Option Elite filter with the new over-the-wire delivery technique at the International Symposium of Endovascular Therapy, to be held in Miami Beach (18–21 January 2014).  

“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 inferior vena cava filters, finding the right combination of features that make a filter easy to deliver, provide stability in the inferior vena cava, and make it easy to retrieve, is a key balance that few designs have achieved. Since its launch in the US market the Option Elite has demonstrated that balance and we are pleased to now offer it to more patients worldwide.”

Argon Medical Devices also announced that the company would begin marketing the Option Elite 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 Option Elite retrievable inferior vena cava filter was designed by Rex Medical, LP for prevention of recurrent pulmonary embolism. 

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