FDA clears 4Fr Nanopuncture Powerwand for vascular access


The US Food and Drug Administration (FDA) has given 510(k) clearance to Access Scientific for its 4Fr Nanopuncture Powerwand. 

The 4Fr Nanopuncture Powerwand is, like the previously FDA-cleared 5Fr version, a power-injectable, peripheral IV catheter that is inserted using the proprietary Accelerated Seldinger Technique.

The Powerwand can be used both for the administration of fluids/medications and for withdrawing blood for diagnostic tests. According to a company release, it is the first and only power-injectable peripheral IV (PIV) catheter capable of delivering continuous IV therapy for the patient’s entire length of hospital stay. The device may be left in place for up to 29 days per its FDA clearance. It is also designed to be an integral part of any programme to reduce central-line associated bloodstream infections (CLABSI).

“The 4Fr version gives the vascular access team more options. An extended-dwell catheter that can be placed both in the upper arm with ultrasound, or in the lower arm or forearm without using ultrasound, is the bridge we needed between the peripheral IV and the PICC. Sometimes with vascular access we need as many options as we can get,” said Peter Hobday, director of the Vascular Access team at Brotman Medical Center, in Culver City, USA.

The Guidelines for the Prevention of Intravascular Catheter-Related infections  now say that patients whose IV therapy will likely exceed six days should have a midline or, if‰Û¥and only if‰Û¥indicated, a central line,” said Steve Bierman, president and CEO of Access Scientific. “Based on recent studies, this means that nearly 30% of hospitalised patients should have a Powerwand.”

In addition to allowing consistent blood draws, the catheter has a flow rate of 130mL per minute‰Û¥making it by far the fastest-flowing peripheral line of its size. “This rapid flow rate capability translates into lives saved in the emergency department, OR and ICU,” said Bierman.