Access Scientific Receives FDA Clearance for The WAND

SAN DIEGO--(BUSINESS WIRE)--Access Scientific, Inc. has received FDA clearance for its MicroAccess WAND®, 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.

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.

“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 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 suites and cardiac catheterization labs. Subsequent iterations -- including the PICC WAND™ and Power WAND™ 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) 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) 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 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, and loss of cannulation. 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® 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, 760-942-2544 Liz@DowlingDennis.net www.DowlingDennis.net

Source: Access Scientific, Inc.

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