The device, from Velano Vascular, could make hospital blood collection easier.
The U.S. FDA has cleared Velano Vascular's device meant to reduce the number of painful needle sticks hospital patients have to go through.
The FDA 510(k) clearance, which Velano (Philadelphia, San Francisco) announced earlier this month, allows for a "common-sense solution" to reduce pain and anxiety for patients, safety risks for healthcare works, and inefficiency in the overall health system, Karen Daley, PhD, RN, and immediate past president of the American Nurses Association, said in a Velano news release.
The FDA's 510(k) summary describes a single-use, needle-free blood collection device that attaches to a peripheral IV system (PIV).
The device, which comes in 20 and 22 gauge sizes, is comprised of an inner tube with a plunger, a proximal flexible tube with female luer, and an outer barrel with a male luer. It is the male luer that attaches to the PIV system. The female luer attaches to a blood transfer device or syringe, from which a blood sample is then collected.
The Velano Vascular device enables newly placed peripheral intravenous (PIV) catheters to be momentarily repurposed to draw blood from patients, reducing the need for additional needle sticks to conduct blood draws.
Blood draw procedures occur 350 million times annually in the United States alone, and 28% of adult venipunctures and 44% of pediatric venipunctures require more than one stick, according to Velano Vascular.
"A fundamental benefit of this technology is reducing the 'pin cushion effect', in which hospitalized patients are 'stuck' several times daily to obtain blood tests. Oftentimes, the draw procedure is plagued by multiple failed attempts," said Eric M. Stone, Velano Vascular's co-founder and CEO. "The FDA's clearance of this novel technology validates the existing clinical need and will allow us to expedite our efforts to bring this innovation to patients, healthcare providers and hospitals around the world."
Also in early February, Velano Vascula announced the closing of a $5 million Series A financing. Investors included First Round Capital, White Owl Capital, Kapor Capital, and Safeguard Scientifics.
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