LENSAR has 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 allowing surgeons to treat additional corneal conditions post cataract surgery.
Image: LENSAR laser system wins FDA Clearance. Photo: Courtesy of analogicus/Pixabay.
“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.
Source: Company Press Release