EXCEL- LENS, Inc. Announce CE Mark Approval for CAPSULaser® Selective Laser Capsulotomy (SLC) Device

Los Gatos, CA – EXCEL-LENS, Inc. announced the CE mark approval of CAPSULaser,

a selective laser that creates a capsulotomy during cataract surgery in just over a second. The laser energy is delivered in a continuous manner rather than a pulsed beam which can create tissue bridges.

In clinical studies CAPSULaser has demonstrated superior consistency compared to manual in creating a capsulotomy that is 100% free-floating and providing 100% 360° IOL coverage.

CAPSULaser offers the surgeon laser precision to pre-select the intended capsulotomy size from 4.5mm to 6.0mm in 0.1mm increments and to utilize the integrated patient fixation beam to center the capsulotomy on the visual axis.

CAPSULaser creates an elastic capsulotomy rim resistant to tearing with a rolled over edge (double thickness), a smooth amorphous collagen rim and a continuous 360° tag free profile. CAPSULaser is a small ergonomic device providing seamless integration into the cataract work flow with no requirement to move the patient as the capsulotomy takes place at the pre-existing OR microscope. CAPSULaser provides a cost and time effective solution to create the ideal capsulotomy with affordable acquisition and running costs, a short and straight forward learning curve and offering a non-invasive procedure with improved visualization throughout the surgery.

EXCEL-LENS, Inc. Chairman & CEO David Mordaunt reported; “I first conceived the idea for CAPSULaser back in 2007. The plan was to create a laser capsulotomy device that would provide both improved patient outcomes and surgeon benefits through its accuracy and simplicity. The journey from conception until today, where we now have approval to directly market in the second largest economic area in the world, has been an exciting journey. I am delighted to be able to announce the CE Marking of CAPSULaser so close to the 36th Congress of ESCRS in Vienna and look forward to meeting with many of the surgeons that have expressed such deep interest in this innovative technology”

Burkhard Dick, Professor of Ophthalmology and Chairman of The University Eye Hospital Bochum, Germany, stated “CAPSULaser has the great potential to completely replace manual capsulorhexis, the most crucial step in modern cataract surgery.“

Sheraz Daya, Chairman and Medical Director of Centre for Sight, East Grinstead, UK added “CAPSULaser I believe will be a very welcome addition to the armamentarium of cataract surgery.  With its ease and rapidity of use along with increased capsular edge strength, the device will make cataract surgery faster, reproducible and safer.  I can see the device potentially on every operating microscope in the future.”

Mr Richard Packard, Arnott Eye Associates, London, UK said; “I was delighted to hear the news that the selective laser device for capsulotomy, CAPSULaser, had received CE mark. This device that has been shown to provide better centred, more accurately sized and circular anterior capsulotomies should help to improve outcomes for cataract and refractive lens exchange surgery. We already know that symmetrical IOL optic coverage reduces posterior capsular opacification. A new generation of IOLs utilising the anterior capsule for fixation may enhance our refractive prediction as well as improving centration of the IOL on the visual axis so important in premium lens implantation.”

Dr Pavel Stodulka, Chief Executive Officer of the Gemini Eye Clinic, Czech Republic was the lead surgeon for the CAPSULaser CE study and was the first to use it clinically. He stated “CAPSULaser is a one of the greatest innovations in cataract surgery in the last 10 years. The surgical step performed by CAPSULaser takes only a second and adds  precision and safety to cataract surgery.“