DORC Receives FDA Clearance for Eva Nexus System
DORC International has announced 510(k) market clearance and the launch of the Eva Nexus.
According to DORC, the Eva Nexus features multiple innovations to improve performance, efficiency, and stability for retina surgeons, including Smart IOP for anterior and posterior chamber stability; DORC’s trocar cannula system with HI-FLOW infusion line; and EVA Inicio, the microinjection system developed for Eva Nexus, the first system approved for subretinal injection.[4]
At ASRS 2022 in New York, DORC also be premiered TDC Veloce, the next generation of TDC (two dimensional cutter) that DORC was the first to launch in 2014. During the limited release phase, more than 4,000 surgeries have been performed with Eva Nexus including the first randomized controlled trial, completed in March 20222.
The detailed highlights of the launch include:
1- Eva Nexus features SMART IOP—a highly responsive infusion mode enabling surgeons to work at lower infusion pressures and maintain a stable anterior and posterior chamber[4].
2- EVA Inicio, a microinjection system designed for precise, ± 1psi control of sub 1ml injections with accompanying cannulas for subretinal injection.
3- DORC trocar cannula system includes the (patent pending) push-fit, HI-FLOW infusion connection with a laser-etched cannula shaft for scleral retention and chamfered leading edge for smoother insertion. Since initial launch, surgeons have reported improved wound sealing[1]
4- Eva Nexus features a host of ergonomic and user-friendly improvements including BSS level detection, vertical and horizontal adjustable monitor, a digital surgical overlay and easy-to-use footbrake for repositioning and locking of the system
5- At ASRS 2022, DORC will also be premiering the new TDC Veloce cutter, combined with SMART IOP and DORC’s unique VacuFlow VTi fluidics will deliver 20,000 cpm and a 20% improvement in aspiration flow rates for reduced vitrectomy time. TDC Veloce also integrates 27G ULTRA technology – refined design and optimized materials combine to provide a 30% improvement in instrument rigidity[3]
6-DORC can also confirm 510(k)-clearance for their range of directional laser probes in 23g-27g, complementing the range of existing laser fibers
"Working with DORC for over 5 years on the development of Eva Nexus, I am confident that it will deliver next generation fluidics, IOP control and vitrectomy efficiency," Asheesh Tewari, MD, said in a company news release.
"For the past 6 months I have been using DORC’s new trocar cannula system that features the HI-FLOW infusion line for superior flow rates[3] and redesigned cannula for improved post-operative wound sealing[1]. These HI-FLOW infusion improvements will be critical to match the increased aspiration flow rates achieved by the new TDC Veloce cutter,” he added.
"510(k) approval for Eva Nexus is another major milestone for DORC. Already used for over 4,000 cases in Europe including a randomized controlled trial[2], Eva Nexus now brings next generation technology to US surgeons," Pierre Billardon, CEO, DORC International, said in a company news release.
"These include SMART IOP for superior chamber stability and IOP control, plus Inicio, the microinjection system developed for Eva Nexus. I am exceptionally proud Eva Nexus is the first approved subretinal injection system. I would like to thank all our US advisory board members who have been instrumental in the development of Eva Nexus. We look forward to introducing Eva Nexus at ASRS in New York,” Mr. Billardon added.
References
1 Total of 40 cases performed by Dr Ash Tewari and published at the Retina Society 2021
2 Data based on 250 surgeries performed by Prof Peter Stalmans, UZL, Belgium
3 Data on file – DORC
4*vs previous generation DORC EVA system
