Access Scientific Receives CE Mark for The WAND MicroAccess Safety Introducer.SAN DIEGO -- Access Scientific, Inc. announced today that it has obtained CE Mark approval for its MicroAccess WAND([R]), the world's first all-in-one safety introducer. The CE Mark enables Access Scientific to sell the MicroAccess WAND broadly around the globe. The device has already 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. The MicroAccess WAND is a sophisticated new medical device that enables clinicians to more quickly and safely insert a sheath or catheter into a patient's 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 device combines 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 in a relatively bloodless procedure. The MicroAccess WAND is designed 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 Cardiac Catheterization Definition Cardiac catheterization (also called heart catheterization) is a diagnostic procedure which does a comprehensive examination of how the heart and its blood vessels function. labs. Subsequent iterations are expected to include the PSI (percutaneous sheath introducer) WAND[TM], 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. The latter two devices are designed to be used primarily by vascular nurse specialists for insertion of PICC and extended-dwell peripheral IVs. "Accomplishing CE Mark approval is the latest step in what continues to be the steady advance toward commercializing The WAND family of safety introducers," 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. "It's also an important milestone in our strategy for reaching the worldwide market for these devices, which is estimated to be more than $2.5 billion annually. We are encouraged by our progress and look forward to announcing other achievements in the near future." The original 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 still carries serious risks for patients and clinicians. The WAND is designed to reduce these risks, which include accidental needlesticks, bleeding, contamination, 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. . Future product iterations are expected to provide additional safety benefits. Dr. Bierman said that CE Mark approval enables Access Scientific to complete discussions, already under way, with international specialty distributors regarding international sales of The WAND. Access Scientific's management team, including Dr. Bierman, has relationships with many of these distributors from its years as the core management team of Venetec International. Venetec, which was subsequently acquired by C. R. Bard C. R. Bard, Inc. (NYSE: BCR) is one of the large S&P 500 companies of the United States, a surgical specialties and hospital medical device manufacturer in Murray Hill, New Jersey. It is named after its founder, who sold the company within only a few years of its founding. , created and marketed the industry-leading StatLock([R]) line of catheter stabilization devices. 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 annually. ASI's team of seasoned medical-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 tward@the-wand.com, or call 858-259-8333. |
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