FDA OKs Velano Vascular’s next-gen needle-free blood draw device

FDA
The PIVO vascular access device is a single-use, disposable device that attaches to a peripheral IV line and allows for needle-free blood draws.

The FDA cleared Velano Vascular’s second iteration of its needle-free blood draw device, which attaches to the peripheral IV line that most hospital patients already have, cutting down on repeated needle sticks that are the norm for blood collection.

A peripheral IV, used to deliver fluids, medication or nutrients, may be used to draw blood, but only upon insertion. The single-use, disposable PIVO device attaches to the IV line and advances a small, flexible catheter through it. From here, the device aspirates blood samples without needing to stick the patient multiple times, said Velano Vascular CEO Eric Stone previously.

While the device makes blood draws more comfortable for the patient, it also reduces practitioners’ exposure to needles, Stone said. In the long term, the PIVO device could potentially standardize blood collection across hospitals and health systems.

The next-generation device is designed to improve ease of use and for high-volume manufacturing, the company said in a statement Monday.

"Feedback from hundreds of practitioners already using our technology reinforced PIVO's ability to enhance the blood draw experience for patients and clinical staff, and helped us to develop a next generation product better suited for widespread adoption,” Stone said in the statement.

The original device earned FDA clearance and a CE mark in 2015. Velano has since partnered with a number of health systems in varying capacities: Sacramento’s Sutter Health signed on to pilot the device last November, while other systems are participating as clinical study partners. The company will make the device available “more broadly” following this new clearance.

Velano isn’t the only player seeking to transform blood collection. The new PIVO clearance comes a week after Seventh Sense Biosystems picked up its own clearance for a “virtually painless” blood collection device. The TAP device uses an array of microneedles and vacuum pressure to draw blood. While it is indicated for the measurement of HbA1c levels in people with diabetes and prediabetes, the company plans to add more tests to be used with the device.