Velano Vascular Snags Third FDA Clearance For Needle-Free Blood Draw Device
Velano Vascular announced that the company has secured a third FDA 510(k) clearance for its next-generation design of PIVO, a device that can collect blood samples through peripheral intravenous (IV) lines, preventing additional and unnecessary needle sticks for hospitalized patients. According to the company, the new design has improved the device’s ease-of-use and suitability for high-volume manufacturing.
PIVO works by temporarily repurposing peripheral IV catheters to draw blood into an attached vacuum tube or syringe. Since the IV line already is in place, there is no need to disturb or even wake the patient to collect a blood sample. The company estimates that U.S. hospitals conduct 300 million blood draws per year, significantly impacting patient comfort and provider safety. The technology was first cleared by the FDA in 2015 and has since undergone several updates.
In early 2016, the device received an additional approval from FDA for new features, including a clamp that allows providers to improve blood draws that require a syringe, which is common with pediatric patents. The changes were based on feedback from practitioners at partnering hospitals, including Children’s Hospital of Philadelphia, Brigham and Women’s Hospital, and U. Penn’s Health System.
Velano Vascular partnered with Sutter Health — a non-profit health network based in California — last November to pilot the needle-free technology. The pilot program served as an initial step toward a broader rollout of the technology. Executives from Sutter commented in a press release about the device’s potential to improve compassionate care measures.
Recent improvements to the device were based on advice from Sutter Health professionals, according to a recent press release. The newest generation of the technology is even more suited for widespread adoption, and is designed to be better suited to large-scale manufacturing.
“Our experience with PIVO illuminates that blood draws can be a painless, lower risk experience for patients and practitioners,” said Anna Kiger, Sutter Health Chief Nurse Officer. “By further improving the usability and accessibility of this innovation, the potential exists for a global standard of more compassionate care.”
Eric Stone, CEO for Velano Vascular, says the new design reflects the company’s commitment to responding to “real world experience” in U.S. hospitals. “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,” said Stone.
Stone added that the company is seeking a broader roll-out of the device in 2017 in pursuit of more widespread adoption for patients with difficult venous access (DVA).
With investments from pharmaceutical firms like Novartis, Massachusetts startup Seventh Sense also is developing a “virtually pain-free” blood draw device that uses a system of tiny needles and a suction device to draw blood, reported the Boston Business Journal. The device, which received FDA approval in January as a device used by healthcare providers to monitor blood sugar, will be available commercially later this year.