5/2/19: LENSAR ® Laser System Receives FDA Clearance to Perform Micro Radial Incisions to Optimize Outcomes of Refractive Cataract Procedures

LENSAR, Inc. has announced it received 510(k) clearance from the U.S. Food and Drug Administration for the LENSAR® Laser System with Streamline® IV, expanding the platform’s capabilities to include the creation of micro radial incisions that allow surgeons to treat additional corneal conditions post cataract surgery.

LENSAR, Inc., is an emerging leader in next-generation femtosecond laser technology for refractive surgery.

“This indication is the latest example of LENSAR responding to the needs and feedback from our customers, those refractive cataract surgeons looking to deploy from a full arsenal of treatment options that support their pursuit of best possible outcomes for patients,” said Nicholas Curtis, CEO of LENSAR. “Our top priority is continuing to build upon our foundation of adaptive innovation with relevant, purposeful and continuous upgrades.”

Micro radial incisions performed with the LENSAR Laser System are guided by the femtosecond laser platform’s powerful imaging capabilities. Fully programmable for depth, length and position by the surgeon based upon the patient’s biometric data, micro radial incisions are used to treat additional corneal conditions.

“The addition of the micro incisional capability to the existing suite of enhancements for managing astigmatism, including arcuate incisions, increases the value of the LENSAR Laser System in delivering on the expectations of the premium cataract procedure,” said F. Beau Swann, M.D., M.S., of Brazos Eye Surgery of Texas. “Particularly for those patients who are not candidates for a LASIK or SMILE procedure, this latest LENSAR innovation offers the surgeon an additional option to improve a patient’s result and, ultimately, level of satisfaction with their choice of a customized, advanced procedure.”

Dr. Swann is participating in the rollout incorporating micro radial incisions into refractive cataract treatment planning with the LENSAR Laser System. The initial data collection will be conducted at two sites. LENSAR has applied for regulatory approval for micro radial incisions in the EU and anticipates the in-market availability of the new feature pending approval.

Note: The LENSAR Laser System with Streamline IV, the fourth LENSAR system upgrade in two years, is the only femtosecond laser on the market today developed specifically for refractive cataract surgery. The LENSAR Laser System helps surgeons manage astigmatism with extreme treatment planning insights featuring quick and easy patient docking, as well as superior imaging capabilities including LENSAR’s proprietary Augmented Reality™ 3-D model. This technology facilitates enhanced procedure outcomes by allowing the physician to develop individualized treatment plans including precise laser delivery and efficient lens fragmentation that can reduce, and potentially eliminate, the amount of ultrasonic energy delivered into the eye. The latest platform upgrade adds the ability to leverage LENSAR’s powerful and adaptive femtosecond laser technology for incisions to perform micro radial incisions and to support presbyopia inlay procedures. 

The LENSAR Laser System has been cleared by the U.S. Food and Drug Administration for anterior capsulotomy, lens fragmentation, corneal incisions including corneal pockets and flaps, and arcuate incisions. For other indications, it is an investigational device limited by U.S. law to investigational use only.

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