Needle-free vascular access device receives FDA clearance

Velano Vascular device
Velano Vascular device

 

Velano Vascular said it has achieved U.S. Food and Drug Administration (FDA) 510(k) clearance for PIVO™, its needle-free vascular access device.

The device is meant to allow for ease-of-use and high volume manufacturing, it said. PIVO is a single-use disposable device that lets workers take samples from indwelling peripheral IV lines, allowing reduction of repeated sticks or central line access.

“The deliberate and thoughtful design inputs for the next generation of PIVO reflect our commitment to rapid product development cycles informed by real world experience in the country's leading health systems,” said Velano Vascular Chief Executive Eric M. Stone. “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.”

PIVO is being used at different health systems and will be available more broadly in 2017. Frost & Sullivan awarded PIVO its New Product Innovation Award for Vascular Access in 2016.