The U.S. Food and Drug Administration has cleared for marketing a new
safety engineered short-term peripheral Intra-Venous (IV) Catheter. The
product, VantageCath™, is designed to
significantly reduce exposure to bloodborne pathogens during the
placement of the catheter and also provide the clinician with desirable
feature sets.
Existing safety engineered peripheral IVs have mechanisms to protect the
needle that has been contaminated but do not usually address the problem
of blood leaking out of an open hub. The VantageCath™
utilizes a closed-hub system that eliminates the need to tamponade
above the site while connecting tubing or saline lock.
“We are delighted to receive the FDA clearance
for VantageCath™ and take the next step
towards bringing this important product to the healthcare industry,”
said Gaylene Fisch, President of Advantage Medical Devices. “The
results of the Simulated Clinical Use study for VantageCath™
confirmed that healthcare professionals want a product that ensures
their safety and combines ease of use with versatility.”
Most needlestick injuries can be prevented with the use of safety
devices, which, in conjunction with worker education and training and
work practice controls, can reduce injuries by over 90 percent. One out
of five healthcare workers sustain a needlestick injury every year. It
is estimated that more than 800,000 injuries occur annually in the
United States from needles and other sharps, according to the Premier’s
Safety Institute brochure “Preventing
Needlestick Injuries.”
Blood safety devices are one of the fastest growing market sectors in
healthcare, driven by regulatory enforcement proceedings regarding
bloodborne pathogen exposure, and the overall need to contain healthcare
costs, including the cost of follow-up treatments for health care
professionals exposed to communicable diseases through such exposure.
The VantageCath™ comes with built in,
needle-free access to empower the clinician with primary needle stick
injury prevention and can immediately be used to deliver push meds,
connect to an extension tubing or standard IV or pump tubing. The VantageCath™
utilizes a push button retraction mechanism for shielding the used
needle that is similar to existing devices to minimize the learning
curve for clinicians and has been well received by nurses, paramedics,
and physicians who used the device during the Simulated Clinical Use
study.
Advantage Medical Devices is pursuing a market presence in the US and
abroad as well as continuing to develop innovative technologies for the
healthcare industry.
ABOUT ADVANTAGE MEDICAL DEVICES
Advantage Medical Devices is an emerging leader in the development and
deployment of safety driven devices for the healthcare market. Its
groundbreaking VantageCath™ Intra-Venous (IV)
Catheter offers the next generation in peripheral venous access.
Advantage Medical Devices’ mission is to
build a portfolio of disposable medical products whose development is
guided by frontline input or invention, and whose forms and function
improves the quality and safety of a clinical setting. For more
information, please visit: www.advmeddevices.com.
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