Option™ELITE Retrievable Vena Cava Filter Receives FDA Clearance for a New Over-The-Wire Delivery Technique and Enters New Markets Worldwide
PLANO, Texas, Jan. 16, 2014 /PRNewswire/ -- Argon Medical Devices, Inc. announced today that the company has received clearance from the US Food and Drug Administration to begin marketing the Option™ELITE 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.
Argon is launching the OptionELITE filter with the new over-the-wire delivery technique at the 26th Annual International Symposium of Endovascular Therapy, to be held in Miami Beach, FL from January 18th – 22nd, 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 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."
Argon Medical Devices, Inc. also announced that the company would 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 Option™ELITE 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.
About Argon Medical Devices
Founded in 1972, Argon Medical Devices, Inc. manufactures medical products and devices for interventional radiology, vascular surgery, interventional cardiology, critical care, and oncology procedures worldwide. Through a network of direct sales representatives and premier distributors, Argon supplies physician customers with breakthrough technologies to improve clinical efficiency and outcomes. Argon is a privately-held portfolio company of Roundtable Healthcare Partners, which is committed to providing clinicians with innovative, technology-driven solutions to improve patient outcomes.
In addition to the Option™ELITE retrievable IVC Filter, the Argon product portfolio is highlighted by the Cleaner™ and Cleaner15™ Rotational Thrombectomy Systems, Atrieve™ Vascular Snare, BioPince™ Full-core Biopsy Instrument, Skater™ Drainage Systems, T-Lok Bone Marrow Biopsy Needles and UltraStream™ Chronic Dialysis Catheters.
About RoundTable Healthcare Partners
RoundTable Healthcare Partners, based in Lake Forest, IL, is an operating-oriented private equity firm focused exclusively on the health-care industry. The partners of RoundTable have significant experience in managing, operating, acquiring and financing multibillion-dollar diversified health-care companies. RoundTable partners with companies that can benefit from its extensive industry relationships and proven operating and transaction expertise.
About Rex Medical, LP
Rex Medical, LP, based in Conshohocken, PA, is a privately held medical device company specializing in the development, manufacturing and marketing of minimally invasive medical devices targeted towards the cardiovascular, venous access, endosurgery and oncology markets. Rex Medical is ISO 13485 certified.
Contact: Tom Younker, 972-272-3888
SOURCE Argon Medical Devices, Inc.