Needle-free vascular access device gets FDA clearance

7th March 2017

Enaie Azambuja

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Velano Vascular announced that it has received U.S. FDA 510(k) clearance for PIVO, its needle-free vascular access device that seeks to improve the blood draw experience for patients while reducing risk to both patients and practitioners. Based on significant usage and input from practitioners, the new, improved device is designed for ease-of-use and high volume manufacturing.

“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 a single-use, disposable device that enables consistent, high quality blood samples from indwelling peripheral IV lines, allowing hospitals to reduce reliance on repeated needle sticks and central line access for blood collection.

In addition to seeking a more compassionate care experience for patients, a safer environment for practitioners, and a more financially responsible alternative for health systems, PIVO aims to equip hospitals to better serve the increasing population of DVA (Difficult Venous Access) patients.

“Our experience with PIVO illuminates that blood draws can be a painless, lower risk experience for patients and practitioners,” explained Sutter Health Chief Nurse Officer Anna Kiger, DNP, D.Sc., MBA, R.N. “By further improving the usability and accessibility of this innovation, the potential exists for a global standard of more compassionate care.”

PIVO is currently in use at multiple health systems nationwide and will be available more broadly in 2017 following this FDA-clearance for the second generation PIVO solution. Frost & Sullivan awarded PIVO its New Product Innovation Award for Vascular Access in 2016.