Avenu Medical, a firm based in San Juan Capistrano, California, won European CE Mark approval to introduce its minimally invasive and cost effective Ellipsys Vascular Access System for creating arteriovenous (AV) fistulas in dialysis patients.
Some details about the device according to the company,
The system enables physicians to percutaneously access the proximal radial artery in the forearm to create an AV fistula. Under high frequency ultrasound guidance, the Ellipsys System uses a novel outer access cannula, guidewire and vessel capture construct that creates a connection of the vein to the artery using an intravascular approach.
A select amount of low power thermal energy is used to cut the walls of the vessels and fuse the tissue, creating an in-vivo anastomosis without leaving any foreign material (including sutures) in the resulting AV fistula. The use of thermal energy has been successfully used in other vessel sealing applications with results equal to or better than traditional suturing methods.
The technology is currently under an Investigational Device Exemption by the FDA in the U.S.
Here's Avenu Medical's animation demonstrating how the device is used:
Product page: Ellipsys Vascular Access System…
Via: Avenu Medical…
The post Ellipsys Vascular Percutaneous System for AV Fistulas Gets EU Green Light appeared first on Medgadget.
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