Velano Vascular Receives Third FDA 510(k) Clearance for Innovative PIVO Needle-Free Blood Draw Technology
Next generation design enables hospitals to deliver more compassionate, standardized, patient-centered blood draws
(firmenpresse) - SAN FRANCISCO, CA -- (Marketwired) -- 02/27/17 -- Medical device innovator announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for PIVO™, its innovative 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.
Velano Vascular is a medical device company committed to reducing the pain, risk, and inefficiencies of vascular access and blood collection practices. The company's revolutionary PIVO device enables needle-free blood draws directly from Peripheral IV catheters, aiming to enable more compassionate care for hospital inpatients, a safer practice for caregivers, and a more financially responsible alternative for health systems. Velano Vascular is backed by a series of well-respected investment firms, health systems, and dozens of health-industry veterans. Company collaborators include several of the leading hospital systems in the United States. More information is available at and (at)velanovascular
Press Contact:
Michael Azzano
Cosmo PR for Velano Vascular
415-596-1978
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Datum: 27.02.2017 - 13:00 Uhr
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