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The PICC WAND from Access Scientific Receives FDA Clearance


1/27/2010 7:08:46 AM

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SAN DIEGO--(BUSINESS WIRE)--Access Scientific has received FDA clearance for The PICC WANDTM, which enables clinicians to insert a peelable sheath for PICC or Midline catheter placement using the new Accelerated Seldinger Technique (AST). The PICC WAND is an all-in-one safety introducer that addresses the over-wire vascular access market, valued at more than $1 billion, by providing faster, safer and simpler vascular access.

The PICC WAND combines all components of the older, Modified Seldinger Technique (MST) -- the needle, guidewire, dilator and sheath -- into one highly efficient device that also protects against accidental needlesticks. Additionally, its “Fast-flash™” feature provides early detection of vessel entry.

“The PICC WAND promises to revolutionize over-wire vascular access. This FDA milestone will truly benefit both patients and healthcare workers,” said Steve Bierman, M.D., CEO of Access Scientific. “Along with our partners at Teleflex Medical, we are proud to introduce The PICC WAND and its game-changing Accelerated Seldinger Technique. We firmly believe this marks the advent of a new and higher standard of care.”

In addition to its unitary design, The PICC WAND Safety Introducer with peelable sheath is designed to reduce the risk of accidental needlesticks, bleeding, contamination, guidewire embolism, and loss of cannulation. Air embolism is among the patient risks of MST that are reduced by The WAND and its Accelerated Seldinger Technique. Beginning in October 2008, the Centers for Medicare & Medicaid Services (CMS) ceased reimbursing healthcare institutions for air embolism, which CMS considers preventable. Air embolism is caused by air bubbles in the bloodstream. The average cost to treat this complication, which can be fatal, is estimated at $66,000 per case.

"The WAND facilitates PICC placement by enabling me to quickly and safely gain venous access,” said Erin Capo, P.A. a vascular access specialist in the New York City metropolitan area. “The innovative design minimizes blood loss, decreases procedure time, optimizes operator safety and increases patient comfort. I have seen these benefits first-hand, and I am convinced that many other vascular specialists will adopt this technology."

The PICC WAND -- one of a series of products from Access Scientific and its platform WAND technology -- is designed to be used primarily by vascular nurse specialists for insertion of PICCs. In development is the POWER WAND™, which is intended to simplify the placement of extended-dwell IV catheters for improved power-injectable vascular access. The POWER WAND has not yet received 510(k) clearance or CE Mark.

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) still carries serious risks for patients and clinicians.

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. 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® 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.

Contact:

Dowling & Dennis Public Relations Liz Dowling, 415-388-2794 Liz@DowlingDennis.net www.DowlingDennis.net


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