Advantage Medical Devices Receives FDA Clearance For VantageCath(TM)

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 May 2008 - 4:00 PDT

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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.

Advantage Medical Devices