Fist Assist Announces CE Mark and European Launch

Fist Assist Devices LLC has received CE Mark and has begun marketing the Fist Assist device for vein enhancement and enlargement in the European Union and other CE Mark countries. Fist Assist is the only wearable, patent protected, intermittent compression device to increase vein diameter prior to fistula placement and 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. It is a huge milestone as we can now expand our commercialization efforts beyond India and into the European,” said Tej Singh M.D., MBA, CEO and founder of Fist Assist Devices LLC . “This is a very exciting time for Fist Assist, patients and the European ESRD community. 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,” said Dr. Nick Inston, specialist vascular access surgeon at University Hospitals Birmingham, one of the largest renal/dialysis centres in Europe. “Access surgery and subsequent maturation is a major challenge and adjuncts to improve outcomes are desperately needed. 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 to use device.”
 
Last year, the company announced the approval of FACT (Fist Assist Clinical Trial) by the University of Chicago Medical Center Institutional Review Board (IRB). This research evaluated the effects of using the Fist Assist device to develop superficial veins prior to arteriovenous fistula (AVF) creation for patients with end-stage renal disease (ESRD) by either surgery or new endovascular procedures.
 
The Fist Assist device is the only wearable, patent-protected intermittent compression device that supports vein dilation for patients with ESRD. The non-invasive device applies intermittent pressure to a specific superficial arm vein to help dilate the vein prior to surgical or endovascular fistula placement. As extensively studied, larger veins before fistula creation can ensure that the fistula reaches optimal size without delays or extra procedures, ultimately reducing costs for both patients and dialysis providers.