FDA clears anterior capsulotomy laser system

The FDA has cleared a laser system (LensAR) for anterior capsulotomy with and without laser phacofragmentation during cataract surgery. The system is being prepared for commercial launch in the United States.

Silver Spring, MD-The FDA has cleared a laser system (LensAR) for anterior capsulotomy with and without laser phacofragmentation during cataract surgery. The system is being prepared for commercial launch in the United States.

According to the company, the new system includes product features specifically intended to improve both surgeon and patient interactions with the system:

• Proprietary technology for three-dimensional (3-D) imaging measurement and beam-guided delivery that generates a personalized surgical treatment plan for capsulotomy incision size and placement based on clean, low-noise images that are both high contrast and high resolution from the anterior surface of the cornea to the posterior capsule.

• The capability to measure lens tilt and decentration in 3-D so that the treatment plan can be aligned with the patient’s unique positioning, anatomy, and visual axis.

• Cataract fragmentation cutting algorithms capable of addressing all cataract grades for easier removal while reducing or eliminating the amount of ultrasound energy required to complete the surgery.

• A laser head and patient docking system that moves to the patient while accommodating a standard patient gurney.

• A system footprint, mobility, and ergonomics that have been designed specifically for compatibility with usual workflows as well as multiple operating room and treatment room layouts.

“The enhancements . . . have been quite impressive and have significantly increased the range of benefits the system can deliver to cataract surgeons,” said Louis “Skip” Nichamin, MD, a member of the company’s medical advisory board. “I’m particularly pleased with the company’s dedication to creating a platform that not only delivers industry-leading clinical outcomes but also considers and addresses the unique practice challenges facing today’s cataract surgeons.”

The company’s commercial laser systems have been installed at the Instituto de Ojos Sacro Cuore in Lima, Peru and at 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.

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