Fist Assist Devices has secured CE mark approval for its wearable, patent protected and intermittent compression device for vein enhancement and enlargement.
The approval allows the marketing of the Fist Assist device in the European Union and other CE mark accepting countries.
Fist Assist device will help increase vein diameter prior to fistula placement
The Fist Assist device will help increase vein diameter prior to fistula placement, as well as facilitate fistula vein dilation for hemodialysis for end-stage renal disease (ESRD) patients.
The device offers a patient-focused evidence-based approach to surgical vein enhancement for all types of arteriovenous fistulas. It will help in enhancing veins before fistula creation and after surgery to optimise maturation.
Fist Assist Devices CEO and founder Dr Tej Singh said: “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 Union.
“This is a very exciting time for Fist Assist, patients and the European ESRD community. Our goal at Fist Assist is to improve outcomes, lower costs, and improve the patient’s journey through ESRD by focusing on vein dilation and enhancement.”
Based in Silicon Valley of San Francisco, the company has developed the Fist Assist technology over the past 30 years.
The patent-protected Fist Assist is focused on the development and commercialisation of an intermittent, external wearable pneumatic compression to optimise forearm vein enhancement and AV fistula dilation.
At present, the Fist Assist device is approved for commercialisation in India and Europe. It is not yet approved in the US for commercial sale.
In February 2020, medical devices maker Cerus Endovascular secured CE mark approval for its Contour Neurovascular System, designed to treat intracranial aneurysms. The system offers a combination of flow diversion and flow disruption through a single device implant.
