FDA clears Access Scientific's POWERWAND catheter

Access Scientific, Inc. today announced it has received FDA 510(k) clearance for the POWERWAND® — an extended-dwell, power-injectable 3.1 inch IV catheter delivered by means of The WAND's® proprietary Accelerated Seldinger Technique.

This new medical device is designed to transform the in-patient experience, by allowing many if not most patients to have one and only one needlestick for vascular access throughout their hospitalization. The POWERWAND can be used both for the administration of fluids/medications and for withdrawing blood for diagnostic tests.

In addition to improving the inpatient experience, the new device can help reduce healthcare workers' risk of an accidental, potentially dangerous needlestick.

"The POWERWAND represents a sorely needed Third Option for vascular access: Where the risks of central venous access are not indicated and the repetitive insertion of peripheral IV catheters to complete therapy is inefficient, costly and ineffective—the POWERWAND provides the answer. We believe it is a game-changing technology that will rapidly become the new standard of care," said Steve Bierman, M.D., CEO of Access Scientific.

Access Scientific intends to distribute The POWERWAND domestically through its own direct sales force.

Access Scientific earlier this month announced it has also received a CE Mark for the POWERWAND, which is planned for initial distribution in Britain, Australia and South Africa.

Preliminary results from The POWERWAND's first clinical trial will be presented at the Infusion Nurses Society annual meeting in May 2011.

The POWERWAND is the second product introduced by Access Scientific. The PICC WAND®, which inserts a peelable sheath introducer into the vasculature by means of the Accelerated Seldinger technique, is currently being distributed by Teleflex Medical.

"We believe that The PICC WAND will set a new standard of care reducing risk to both patients and healthcare workers and that The PICC WAND's safety and efficiency features provide significant benefits to the healthcare providers we serve," said Tim Shannon, Vice-President Vascular, North America at Teleflex Medical.