Lensar Receives FDA Clearance of the ALLY Adaptive Cataract Treatment System

Lensar announced FDA 510(k) clearance for its ALLY Adaptive Cataract Treatment System. ALLY is the first FDA-cleared platform to enable cataract surgeons to complete the femtosecond-laser-assisted cataract surgery (FLACS) procedure in a single, sterile environment.

"The (FDA clearence) is the culminiation of a lot of work that the company has put in to bring a true next-generation technology," Nick Curtis, Chief Executive Officer of Lensar, said in an interview with EyewireTV. "ALLY is really going to be unique in many, many ways. The system is a fraction of the size of current femtosecond lasers. In fact, it’s just slightly larger than phacoemusification systems are today in most of the facilities. It also could be placed anywhere in an operating room or in-office surgical suite. It can be placed anywhere within a 240-degree radius of the patient."

In addition to enhanced ergonomics, Mr. Curtis said the system's dual-pulsed laser and advanced astigmatism management tools has the potential to improve surgeon efficiencies and deliver improved outcomes for patients.

To view the entire EyewireTV interview with Mr. Curtis, click here.

ALLY is the first cataract surgery platform to provide 'Adaptive Intelligence' to automatically determine cataract density, optimize fragmentation patterns, and energy settings, with the goal of minimizing overall energy delivered to complete the cataract procedure more efficiently and help contribute to quicker visual recovery, and better patient outcomes. These proprietary features, combined with advanced astigmatism management technology, have the potential to establish new standards for femtosecond laser cataract surgery procedures. The ability to automate surgeons’ treatment plan, while improving time and workflow is a benefit to surgeons, patients, and operating room staff.

Mr. Curtis said the list price of the combined femto and phaco device will be $400,000, plus a per procedure fee that will vary depending on the procedure being performed.

This week’s FDA clearance is for system’s femtosecond laser capabilities, which is the first stage of a two-step commercial release strategy. The company plans to deliver the first ALLY Systems to surgeons in the third quarter of this year through a controlled targeted initial launch. Following this launch, the company plans to make ALLY widely available to cataract surgeons in 2023.