Argon Medical's CLEANER XT™ and CLEANER 15™ Rotational Thrombectomy Systems Receive FDA Clearance for Mechanical Declotting and Infusion in the Peripheral Vasculature
PLANO, Texas, Nov. 19, 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 CLEANER XT™ and CLEANER 15™ Rotational Thrombectomy Systems for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature. This new clearance enables physicians to apply CLEANER's capability for cleaning wall-adherent thrombus to the peripheral vasculature when an IVC filter is present. This indication augments Cleaner's existing clearance for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. Venous thromboembolism (VTE) is the third most prevalent cardiovascular illness following acute coronary syndrome and stroke1, and it is estimated that there are approximately 1 million cases in the US each year2.
The CLEANER Rotational Thrombectomy System is immediately available for use in the peripheral vasculature, and Argon is formally launching the new indication at the 27th Annual International Symposium of Endovascular Therapy, to be held at the Diplomat Hotel in Hollywood, FL from January 31st to February 4th, 2015.
"Safely expanding the application of the CLEANER family of products to the peripheral vasculature means more effective therapy for patients suffering from peripheral thrombosis and occlusions," stated George Leondis, President of Argon Medical Devices. "Combining an atraumatic approach with efficient thrombus removal is unique among thrombectomy devices, and we are excited to make this product available for a wider range of applications."
The CLEANER family of Rotational Thrombectomy Systems is available from Argon Medical Devices, and is designed by Rex Medical, LP. With the FDA's clearance of this new indication, patients requiring treatment of thrombus in the peripheral vasculature will have access to advanced therapy with the CLEANER family of devices.
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 CLEANER XT and CLEANER 15 Rotational Thrombectomy Systems, the Argon product portfolio is highlighted by the OptionELITE™ Retrievable Vena Cava Filter, 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.
- Goldhaber SZ: Pulmonary embolism thrombolysis: A clarion call for international collaboration. J Am Coll Cardiol 1992;19(2):246-247.
- Anderson FA Jr, Wheeler HB, Goldberg RJ, et al: A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch Intern Med 1991;151(5):933-938.
SOURCE Argon Medical Devices, Inc.
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