Velano Vascular, a medical technology company transforming and enhancing the care experience for hospitalized patients and their practitioners, announced that the company received U.S. Food and Drug Administration (FDA) clearance for a modified version of its novel, needle-free blood draw device. The Velano device is designed to reduce blood draw-related discomfort and anxiety for hospital inpatients, provide a safer work environment for healthcare providers, and standardize today’s fragmented approaches to inpatient blood draws.
This second FDA clearance of the company’s patented technology includes two modifications designed to enhance the product’s usability for inpatient blood draws, one of the most common medical procedures performed today: The addition of a clamp for use with syringe draws, a frequent practice in pediatric patients, and a refinement to the Indication for Use (IFU). The Velano device is attached to a peripheral IV catheter to draw blood directly into a vacuum tube or a syringe; the revised IFU removes a limitation in the earlier clearance that specified when the device could be used with in-dwelling peripheral IV catheters.
“We rapidly implemented and pursued FDA clearance for these modifications based on input from patients and medical professionals who are using and systematically assessing our blood-draw technology,” said Eric M. Stone, co-founder and CEO of Velano Vascular. “These enhancements reflect our customer-centric approach to introducing our technology into medical practice, both in terms of product enhancements and clinical use patterns.”
Velano Vascular is working closely with clinical and non-profit partners including Brigham and Women’s Hospital, Intermountain Healthcare, Griffin Health, The University of Pennsylvania Health System, The Children’s Hospital of Philadelphia, Children’s National Hospital, and Planetree to capture patient and practitioner input regarding today’s approaches to inpatient blood draws and how the Velano technology could eventually become a standard of care.
The Need for New Blood-Draw Technology
Roughly 760 inpatient blood draws are conducted every minute in the United States alone. Despite their ubiquity, blood draws create tremendous disruption for patients and clinicians alike, and are associated with significant direct and indirect costs. Twenty-eight percent of adult venipunctures and 44 percent of pediatric venipunctures require more than one stick to successfully draw blood,1 and around 10 percent of children aged 3 to 10 years old must be physically restrained to endure a needle-based blood draw.2 Published data suggest that U.S. healthcare professionals endure an average of 200 needle-related injuries each day.3 Aside from the significant physical and emotional toll of these injuries and any related seroconversion, studies suggest that accidental needle sticks cost hospitals upwards of $50 million per year.4
1Frost and Sullivan, 2009
2Spagrud LJ, von Baeyer CL, Ali K, Mpofu C, Fennell LP, Friesen K, Mitchell J. Pain, distress, and adult-child interaction during venipuncture in pediatric oncology: an examination of three types of venous access. J Pain Symptom Manage. 2008 Aug;36(2):173-84
3Laramie AK, Firsova N, Davis L, State Based Surveillance of Sharps Injuries among Hospital Workers, 2002-2004, American Journal of Infection Control, Volume 35, Issue 5, Page E166, June 2007.
4Cost of a high-risk accidental needle stick injury is approximately $5,144 per incident. Frost & Sullivan Economic Model, Version 3.1, 2007