DORC International is delighted to confirm 510(k) market clearance for EVA NEXUS. With EVA NEXUS, US retina surgeons welcome the future of ophthalmic surgery, with multiple innovations to improve performance, efficiency and stability. These include SMART IOP for superior anterior and posterior chamber stability, DORC’s ground-breaking 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. At ASRS 2022, DORC will also be premiering TDC VELOCE, the next generation of TDC (two dimensional cutter) that DORC was the first to launch in 2014. During the limited release phase, over 4000 surgeries have been performed with EVA NEXUS including the first randomized controlled trial, completed in March 2022.
The detailed highlights of the launch are as follows:
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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.
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EVA INICIO, a microinjection system designed for precise, ± 1psi control of sub 1ml injections with accompanying cannulas for subretinal injection.
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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
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Plus, 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-touse footbrake for repositioning and locking of the system
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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
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TDC VELOCE also integrates 27G ULTRA technology – refined design and optimized materials combine to provide a 30% improvement in instrument rigidity
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DORC can also confirm 510(k)-clearance for their range of directional laser probes in 23g – 27g – complementing the range of existing laser fibers
Key Surgeon & Corporate Testimonials
Dr Asheesh Tewari, MD (US) - ‘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. 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 rates3 and redesigned cannula for improved post-operative wound sealing . These HI-FLOW infusion improvements will be critical to match the increased aspiration flow rates achieved by the new TDC VELOCE cutter.’
Dr Audina Berrocal, MD (US) - ‘Gene and cell therapies are the future of retinal disease treatment. As retina surgeons we will need access to systems and instrumentation that are proven to offer the precision and control for delivery of microinjections to the subretinal space. It is exciting to hear that EVA NEXUS is the first system to receive FDA clearance for this application and I am looking forward to evaluating the technology.’
Pierre Billardon, CEO, DORC International - ‘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 trial2 , EVA NEXUS now brings next generation technology to US surgeons. 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.'
To learn more, visit dorcglobal.com.
Source: DORC International