LENSAR Receives FDA Clearance to Perform Corneal Pockets and Flaps for Corneal Inlay Procedures

LENSAR Inc., a developer of next-generation femtosecond laser technology for refractive surgery, 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 the corneal pockets and flaps used in ophthalmic procedures treating presbyopia.
 
With the new indications, the LENSAR Laser System, known for its 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 United States in 2018. LENSAR has applied for regulatory approval in the European Union and anticipates availability of the new features there later in the year, pending approval.
 
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 and features 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 presbyopia inlay procedures.
 
LENSAR Inc. develops next-generation femtosecond laser technology for refractive cataract surgery. The LENSAR Laser System with Streamline IV offers cataract surgeons automation and customization for their astigmatism treatment planning and other essential steps of the refractive cataract surgery procedure with the highest levels of precision, accuracy, and efficiency. These features assist surgeons in managing astigmatism treatment for optimal overall visual outcomes.
 
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. LENSAR Inc. is a wholly-owned subsidiary of PDL BioPharma Inc.