Fist Assist Devices recently announced that it received CE Mark approval for its Fist Assist device for vein enhancement and enlargement.
Los Altos Hills, Calif.-based Fist Assist Devices said it has begun commercialization and marketing of the device in the European Union.
The Fist Assist device is a non-invasive external platform designed to utilize a pneumatic balloon for intermittent vein compression in hemodialysis fistula development and phlebotomy procedures.
Fist Assist Devices touts its product as the only wearable, patent-protected intermittent compression device designed to increase vein diameter prior to fistula placement. It is also designed to assist in fistula vein dilation for hemodialysis for end-stage renal disease (ESRD) patients.
“We are thrilled to have received CE mark approval for Fist Assist,” Fist Assist Devices founder & CEO Dr. Tej Singh said in a Feb. 21 news release. “Our goal at Fist Assist is improve outcomes, lower costs, and improve the patients journey through ESRD by focusing on vein dilation and enhancement.”
“Fist Assist provides a patient-focused, evidence-based approach to surgical vein enhancement for all types of arteriovenous fistulas and can be used to enhance veins before fistula creation as well as after surgery to improve maturation,” added University Hospitals Birmingham (U.K.) specialist vascular access surgeon Dr. Nick Inston. “Fist Assist is a creative solution which for the first time allows patients to be involved and directly influence their clinical outcomes with a comfortable and easy-t0-use device.”