510(k) clearance to Velano Vascular’s PIVO by FDA

Withdrawing of blood is the basic need for the diagnosis of several diseases. Recently, Velano Vascular gained a 510(k) clearance from the Food and Drug Administration for its second generation of the PIVO needle-free blood draw technology. The expendable tool assists to collect blood samples from inward peripheral IVs, aiding to prevent additional needle sticks and do not require to collect blood from the central lines. On the basis of noteworthy use and contribution from practitioners, this new, enhanced tool is developed for user-friendliness and high-volume manufacturing.

The PIVO is presented with a catheter that is positioned into the peripheral IV and pressed downward into the blood vessel by which blood is drawn back into the reservoir of PIVO. It is not provided with any needles further decreasing the possibility of injuries to the workers and need of extra needle sticks for the individual consisting of all the outcomes these events can bring in. Apart from attempting for a more concerned care experience for patients, a more economically dependable substitute for health systems, and safer surroundings for professionals, PIVO intends to furnish hospitals so as to offer the rising number of people with difficult venous access patients a better service.

The Chief Executive of Velano Vascular, Eric M. Stone, said, “Opinion from several practitioners utilizing our technology previously strengthened the capability of PIVO to improve the experience of blood drawing for clinical staff and patients, and assisted us to design a next-generation device well-suited for global adoption.”

The PIVO device is designed to be gentler on the patient and also made its manufacturing simpler and cheaper, serving to support its adoption.

Anna Kiger, Sutter Health Chief Nurse Officer, said, “Our practice with PIVO demonstrates that drawing of blood can be a painless, reduced risk potential for practitioners and patients. By further enhancing the accessibility and usability of this device, it is capable of becoming a worldwide standard of more concerned care.”

At present, PIVO is already utilized by few hospitals across the country. And now with the clearance issued by the FDA, it can be made accessible with general distribution later this year.

We hope the device is successful in providing the practitioner and patients with a better experience.