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FDA clears LensAR system for anterior capsulotomy, laser phacofragmentation
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A next-generation commercial laser system from LensAR for use in anterior capsulotomy, with and without laser phacofragmentation, during cataract surgery has received 510(k) clearance from the U.S. Food and Drug Administration.
The regulatory action covers the new LensAR system that will be launched commercially in the United States, according to a company press release.
“In terms of accuracy in cutting and placing our capsulotomies and in the efficiency of our phacofragmentation, we believe that we have the most effective system,” Nicholas T. Curtis, CEO of LensAR, said in an interview with Ocular Surgery News. “There’s no OCT involved in our imaging system. There’s a unique system to LensAR, which includes our automated 3-D imaging, biometric measurement and beam guidance delivery.”
System features
A Scheimpflug angle camera is used to capture the front surface of the cornea to the back of the posterior surface of the lens in one frame. This gives a high signal-to-noise image that has the ability to see the real endpoints of the anatomy of each patient in high-definition detail. A scanning process is used to take two images in up to eight different positions, which allows the practitioner to then use wave tracing to create a 3-D reconstruction of the patient’s actual biometric measurements and anatomy, Mr. Curtis said.
“The enhancements that LensAR has made to its technology have been quite impressive and have significantly increased the range of benefits the system can deliver to cataract surgeons,” Louis D. “Skip” Nichamin, MD, a member of LensAR’s medical advisory board and OSN Cataract Surgery Board Member, said in the press release.
The system reduces or eliminates the amount of ultrasound energy needed to complete surgery due to improved cataract fragmentation cutting algorithms that can address all cataract grades, the release said. It also allows for precise measurement of lens tilt and decentration in 3-D to better align the treatment plan with the patient’s eye positioning and anatomy.
“Because of the true 3-D imaging and the ability to measure the lens tilt in a true 360° plane, we can cut the anterior capsulotomy in a symmetrical fashion during treatment to automatically size it, shape it and locate it exactly on the optical axis, pupil center or cornea, wherever the physician determines the best overall effective lens position to be postop,” Mr. Curtis said.
A non-contact, fluid-based interface is used to prevent corneal folds or striae and provides more accurate laser treatment.
The system’s laser head and patient docking system can move to the patient while accommodating a standard patient gurney. The system is ergonomic and designed for compatibility with a variety of operating or treatment room layouts.
The total time of the procedure, including docking, is about 3 minutes, Mr. Curtis said.
Worldwide expansion
Commercial LensAR systems have been installed at the Instituto de Ojos Sacro Cuore in Lima, Peru, and the Asian Eye Institute in the Philippines. Members of the company’s medical advisory board and nearly 30 select surgeons have conducted procedures on these systems. The system has been used in more than 800 eyes outside the United States.
U.S. meetings will have LensAR representatives available, and there will be demonstrations of the system. Topcon, LensAR’s European distributor in 10 countries, will have a presence at all European meetings. – by OSN Staff