Access Scientific Gets FDA Clearance for 4Fr Nanopuncture POWERWAND.
SAN DIEGO -- Access Scientific, Inc. announced it has received FDA 510(k) clearance for the 4Fr Nanopuncture[TM] POWERWAND[R]. The unique peripheral IV catheter (technically a midline at 3.1 inches) is lighter and designed to provide smoother handling and even greater ease of insertion.
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. 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 program to reduce central-line associated bloodstream infections (CLABSI).
The catheter has been well received by hospitals using it. "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, RN, CCRN, CRNI, Director of the Vascular Access team at Brotman Medical Center, in Culver City, Calif.
The POWERWAND's versatility makes it the first and best choice for many patients, said Steve Bierman, M.D., president and CEO of Access Scientific.
"CDC Guidelines now say that patients whose IV therapy will likely exceed six days should have a midline or, if -- and only if - indicated, a central line," Dr. Bierman said. "Based on recent studies, this means that nearly 30% of hospitalized patients should have a POWERWAND."
In addition to allowing consistent blood draws, the catheter has a flow rate of 130 mL per minute -- 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 Dr. Bierman.
The POWERWAND has several notable safety features:
* Alternative to central lines. Because it is not a central line, the catheter does not carry the same high risk of potentially fatal bloodstream infections. Midline catheters such as the 4Fr Nanopuncture POWERWAND have the lowest published bloodstream infection rate of all inpatient vascular access devices.
* Low complication rate. The POWERWAND has the lowest complication rate ever reported in studies of vascular access devices.
* Kink resistance. The POWERWAND catheter is made of ChronoFlex[R] C--exclusively available on the POWERWAND--which, owing to a proprietary process, makes it virtually kink-free in almost all clinical situations.
Other POWERWAND/Accelerated Seldinger Technique benefits include:
* Greater patient satisfaction, due to extended dwell time and blood draw-ability. In a published, peer-reviewed study (JAVA, Spring 2012), patients rated their satisfaction with the device at 98.7%. By comparison, only a minority of patients (42%) reports being satisfied about their experience with other kinds of peripheral IVs.
* Ease of insertion. Whether insertion is ultrasound-guided or by direct visualization, the Accelerated Seldinger Technique is an easier, safer, and faster method than the conventional Modified Seldinger Technique.
* Improved safety for patients and healthcare workers, by reducing the risk of accidental needlestick, guidewire and air embolism, contaminated components, and splash contamination.
"Our goal with the POWERWAND has been to deliver the safest, most reliable catheter a patient can have, using a technique that keeps healthcare workers safe as well. The published and presented studies demonstrate that we've met that goal," said Dr. Bierman.
POWERWAND instructional video
Study Shows POWERWAND Achieves Unprecedented Success for IV Therapy
Hospital Reports High Patient Satisfaction with POWERWAND
Access Scientific Gets FDA Clearance for POWERWAND (March 29, 2011)
CME Course from Hadaway & Associates:
"The Perils of Power Injection"
About Access Scientific
Access Scientific, Inc., a privately held medical device company, is dedicated to providing a safer standard of vascular access through its proprietary WAND[R] 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[R] catheter stabilization devices and made them the worldwide standard.
For further information, go to www.The-Wand.com, email Customer Service at PCook@the-wand.com, or call 858-259-8333.
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|Date:||Sep 13, 2012|
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