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LENSARĀ® Laser System Receives FDA Clearance to Perform Corneal Pockets and Flaps for Corneal Inlay Procedures

Date Announced: 11 Apr 2018

LENSAR Laser System with Streamline™ IV Expands the Powerful Refractive Cataract Femtosecond Platform to Support the Surgical Treatment of Presbyopia.

ORLANDO, Fla.--(BUSINESS WIRE)--LENSAR, Inc., an emerging leader in next generation femtosecond laser technology for refractive surgery, today 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 the corneal pockets and flaps used in ophthalmic procedures treating presbyopia.

With the new indications, the LENSAR Laser System, known for its superior diagnostic capabilities and precision in performing cataract procedures that drive excellent patient outcomes, now supports surgeons offering the latest presbyopic inlay devices to patients struggling with the loss of near vision due to aging.

“The continued expansion of capabilities with the LENSAR Laser System is the latest demonstration of our commitment to technological innovation that serves surgeons pursuing excellent visual outcomes for their patients,” said Nicholas Curtis, CEO of LENSAR. “LENSAR’s technology is known for its adaptability and high-quality treatment capability. It made sense to evolve our platform to support surgeons meeting the increasing patient demand with options for the treatment of presbyopia with corneal inlay devices.”

The presbyopia procedure features of the LENSAR Laser System with Streamline IV include a new curved contact patient interface device that enables the creation of corneal pockets and flaps without compromising patient comfort.

“This latest innovation from LENSAR speaks to the company’s strong partnership with its customers. Adapting the LENSAR platform for stromal pockets and corneal flaps delivers on their promise to expand the platform capabilities to facilitate presbyopia inlay procedures,” said Gregory Parkhurst, M.D., F.A.C.S. of Parkhurst NuVision. “LENSAR has always been open to feedback from its customer base and this clearance is just the latest example of their ability to incorporate the clinical experience with the technology to drive innovation.”

The new presbyopia procedure capabilities will be rolling out to LENSAR users in the U.S. in 2018. LENSAR has applied for regulatory approval in the EU and anticipates availability of the new features there later in the year, pending approval.

Source: LENSAR


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