January 16, 2014
FDA Clears OTW Delivery Technique for Argon Medical's OptionElite Retrievable IVC Filter
January 16, 2014—Argon Medical Devices, Inc. (Plano, TX) announced that the company has received clearance from the US Food and Drug Administration to begin marketing the OptionElite retrievable inferior vena cava (IVC) filter with a new over-the-wire (OTW) delivery technique.
The company originally launched the OptionElite for the prevention of recurrent pulmonary embolism in March 2013. Rex Medical, LP (Conshohocken, PA) designed the OptionElite.
According to the company, 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 OTW technique is a standard of care in many endovascular procedures.
“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,” commented Munier Nazzal, MD, in the company’s press release. Dr. Nazzal is Chief of Vascular and Endovascular Surgery at the University of Toledo in Toledo, Ohio.
Argon is launching the OptionElite filter with the new OTW delivery technique at the ISET 2014: International Symposium of Endovascular Therapy conference to be held January 18–22 in Miami Beach, Florida.
Argon Medical Devices also announced that the company 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 there.