Velano Vascular has received CE Mark (Conformite Europeenne), a significant confirmation of medical device quality from the European Union for its novel blood-draw technology.
This regulatory milestone further validates the new technology as a promising alternative to one of the most common procedures in medicine – the in-patient blood draw.
Velano Vascular’s proprietary device reduces the need for needle sticks (clinically known as venipunctures) for blood draws in the hospital. The CE Mark is granted for use of the device in blood specimen collection from a peripheral intravenous (PIV) catheter. Using the disposable, single-use Velano Vascular technology, newly placed PIV catheters can be momentarily repurposed to draw blood from patients, thereby reducing the need for additional needle sticks to conduct blood draws among hospitalized patients, the majority of whom have IVs in place.
Velano Vascular co-founder and president Pitou Devgon, MD said: "This important regulatory approval underscores the need for this technology around the world.
"Our aim is to improve the way medicine has been practiced for decades in order to improve the patient experience and increase safety for medical professionals. Receiving CE Mark moves us one significant step closer to that goal."
The company recently announced a research collaboration with Brigham and Women’s Hospital, and has initiated clinical trials of their novel device in the United States.
The Need for New Blood-Draw Technology
One out of every three hospital patients is stuck two or more times daily for blood draws throughout their hospitalization, with a significant subset of these inpatients receiving as many as three blood draws or greater per day, according to research by Velano Vascular. Twenty-eight percent of adult venipunctures and 44 percent of pediatric venipunctures require more than one stick to successfully draw blood.