09.30.19

DORC Obtains 510k Clearance for Launch of EVA Upgrade Enhancements

Source: DORC

DORC has announced 510(k) clearance for a range of enhancements to the EVA surgical system. The enhancements has been developed in close collaboration with surgeons and deliver both OR efficiency and surgical performance to users, according to a company news release.

First, the EVA footswitch has been completely redesigned. Control of the EVA endolaser is now integrated into the main footswitch providing seamless switching between vitrectomy to laser, and eliminating the need for a secondary laser pedal. In addition to improving efficiency, any surgeon can operate independent of tech support when switching to laser, according to DORC. The new footswitch also has a range of ergonomic enhancements to ensure optimal surgeon comfort during longer procedures. The footswitch provides dual linear (vertical and horizontal) movement and 6 switching functions that can be reached without removing the foot from the pedal, and a new heel rest to provide a more comfortable resting point and a lower angle of operation. With regard to laser function, the footswitch provides two functions–adjustments to power settings and laser firing. The EVA Footswitch can also be used in wireless or in wired connection. It is also the first surgical system footswitch to feature interchangeable inlays (patent pending) allowing the surgeon to choose from 4 currently available options that can be easily switched. DORC also plans to offer customizable inlays at a future date.

Second, the EVA LED light source has been improved to provide significantly increased illumination with smaller gauge fibers versus the prior LED output, with even greater enhancement possible when combined with the improved 27g light fibers launched in 2018. This advancement has been developed in response to demand for improved illumination from the growing number of surgeons working with 27g.

“I am very excited about these enhancements, integration of laser control saves me time plus the more ergonomic design, inlays and fully programmable set-up gives me more control. The increased light output further enhances the continued used of the DORC 27g platform,” Gaurav Shah, MD, or the Retina Institute, St Louis, said in the news release.

The upgraded EVA system will be available at the DORC booth at the upcoming AAO meeting in San Francisco. From October, the enhancement will be implemented in all new EVA systems shipped to the US and the enhancements can also be retro-fitted to all existing EVA posterior and combined systems installed in the United States.

The enhancements received CE mark in December 2018.

 

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