Access Scientific Receives FDA Clearance for The WAND.All-in-One MicroAccess Safety Introducer Enables Accelerated Seldinger Technique; Protects Patients & Clinicians SAN DIEGO -- Access Scientific, Inc. has received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. clearance for its MicroAccess WAND([R]), the world's first all-in-one safety introducer. This sophisticated new medical device enables clinicians to more quickly and safely insert a sheath or catheter into the peripheral vasculature vasculature /vas·cu·la·ture/ (vas´ku-lah-chur) 1. circulatory system. 2. any part of the circulatory system. vas·cu·la·ture n. . The MicroAccess WAND is the first of several planned WAND devices from Access Scientific to receive FDA clearance. The devices combine all components of the older, Modified Seldinger Technique into a unitary device that provides faster, safer, simpler over-wire vascular access vascular access Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing . "The MicroAccess WAND is the first device to enable clinicians to perform the Accelerated Seldinger Technique, which we believe is the ultimate refinement in vascular access technology," said Steve Bierman, M.D., CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Access Scientific. "FDA clearance of the first version of The WAND marks a major step forward in making the Accelerated Seldinger Technique available to clinicians." The first clinical sites will begin using the device immediately, Dr. Bierman said, now that it has received FDA clearance. The MicroAccess WAND is expected to be used primarily in interventional radiology interventional radiology Imaging A subspecialty of radiology that provides Diagnostic information–eg, CT-guided 'skinny' needle biopsies and dye injection for analysis of various lumina and tracts–eg, arteriography, cholangiography, antegrade suites and cardiac catheterization labs. Subsequent iterations -- including the PICC PICC Peripherally-inserted central catheter Critical care An IV catheter inserted in the superior vena cava for long-term infusion of bolus or continuous delivery of therapeutics or TPN–drugs, fluids, nutrients, chemotherapy. Cf Catheter. WAND[TM] and Power WAND[TM] now in development - are designed to be used primarily by vascular nurse specialists for insertion of peripherally inserted central catheters (PICCs) and extended-dwell peripheral IVs. Together, the competitively priced WAND devices address a potential worldwide market of more than $2.5 billion. The Seldinger technique was developed in 1953 to reduce complications associated with the introduction of catheters and other medical devices into blood vessels and hollow organs. Because there have been few significant improvements to the technique since it was invented, what is now known as the Modified Seldinger Technique (MST See micro systems technology. ) still carries serious risks for patients and clinicians. Among the patient risks of MST that are reduced by the Accelerated Seldinger Technique is air embolism. Beginning in October 2008, the Centers for Medicare & Medicaid Services (CMS (1) See content management system and color management system. (2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system. ) ceased reimbursing healthcare institutions for air embolism, which CMS considers preventable. Air embolism, which can be fatal, is caused by air bubbles in the bloodstream. Insertion or removal of a central venous catheter central venous catheter n. A catheter passed through a peripheral vein and ending in the thoracic vena cava; it is used to measure venous pressure or to infuse concentrated solutions. is among the procedures that can lead to an air embolism. The average cost to treat this complication is estimated at $66,000 per case. "Studies have already demonstrated The WAND's ability to reduce the risk of an air embolism by 50%, while also providing passive needlestick safety," Dr. Bierman said. "Because The WAND provides both clinical and cost-savings advantages, we expect to see strong early adoption of the Accelerated Seldinger Technique among leading clinicians." In addition to uniting the elements needed to perform the Seldinger technique into one unitary device, The WAND is designed to reduce the risk of accidental needlesticks, bleeding, contamination, guidewire embolism embolism Obstruction of blood flow by an embolus—a substance (e.g., a blood clot, a fat globule from a crush injury, or a gas bubble) not normally present in the bloodstream. Obstruction of an artery to the brain may cause stroke. , and loss of cannulation can·nu·la·tion or can·nu·li·za·tion n. Insertion of a cannula. cannulation introduction of a cannula into a tubelike organ or body cavity. . Its "Fast-flash" feature provides early detection of vessel entry. About Access Scientific Access Scientific, a privately held medical device company, is dedicated to providing a safer standard of over-wire vascular access through its proprietary WAND technology. Designed to provide the fastest, safest, simplest over-wire catheter insertion, The WAND enables clinicians to perform the Accelerated Seldinger Technique. The total market opportunity for the company's products is estimated to be more than $2.5 billion worldwide. ASI's team of seasoned device-company veterans is focused on improving patient and healthcare worker safety through the combination of superb design/engineering and exacting quality assurance. The WAND was developed by the same Venetec International, Inc. team that invented StatLock([R]) catheter stabilization devices and made them the worldwide standard. For further information on the company, go to www.The-Wand.com, email Customer Service at PCook@the-wand.com, or call 858-259-8333. |
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