Access Scientific Receives CE Mark For The WAND MicroAccess Safety Introducer

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Jan 2009 - 2:00 PDT

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Access Scientific, Inc. announced that it has obtained CE Mark approval for its MicroAccess WAND®, 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 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. The device combines all components of the older, Modified Seldinger Technique into a unitary device that provides faster, safer, simpler over-wire vascular access in a relatively bloodless procedure.

The MicroAccess WAND is designed to be used primarily in interventional radiology suites and cardiac catheterization labs. Subsequent iterations are expected to include the PSI (percutaneous sheath introducer) WAND™, PICC WAND™ and Power WAND™ 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 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, and loss of cannulation. 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, created and marketed the industry-leading StatLock® 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® catheter stabilization devices and made them the worldwide standard.

Access Scientific