Cleaner15 Rotational Thrombectomy System from Argon Coming to Market

January 16th, 2013 Editors Vascular Surgery

Argon Medical (Plano, TX) is releasing the Cleaner15 Rotational Thrombectomy System, a system manufactured by Rex Medical (Conshohocken, PA) to allow physicians to restore flow in occluded arteriovenous fistulae and synthetic grafts in patients with ESRD (End Stage Renal Disease). From Argon:

The Cleaner15™ Rotational Thrombectomy System utilizes a 15mm single, sinusoidal wire that allows for safe and effective thrombus removal. The 0.044 wire combined with the increase in torque provides the physician with the power needed for difficult declot cases resulting in reduced procedure time, along with enhanced steerability in tight stenoses and aneurysms.

Argon Medical will be exhibiting at the 25th Annual International Society of Endovascular Therapy (ISET) Scientific Meeting to be held in Miami, FL from January 19th thru the 23rd at the Fontainebleau Miami Beach.

Press release: Argon Medical Devices, Inc. Announces the Launch of the Cleaner15™ Rotational Thrombectomy System

Flashback: Rex Medical Cleaner Rotational Thrombectomy System Wins US Green Light

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18octallday19alldayWorld Congress on Polycystic Ovarian Syndrome and Fertility, 2018Abu Dhabi, UAE

18octallday19alldayManaging Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an InspectionMinneapolis, MN, USA

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Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

How to overcome one of the biggest obstacles device manufacturers face
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

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Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.

Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions.

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october 18 (Thursday) - 19 (Friday)

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Compliance Online 80068SEM

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18octallday19allday18th Global Ophthalmology, Optometry and Glaucoma Conference, 2018Helsinki, Finland

18octallday19alldayBiology and Pathology of Infectious Disease Conference, 2018Helsinki, Finland

18octallday19allday14th Global Biomarkers Summit, 2018Amsterdam, Netherlands

22octallday23alldayInternational Conference on Breast Cancer, 2013Vancouver, British Columbia, Canada