LENSAR, Inc., 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.
Lensar reports 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.
Nicholas Curtis, CEO of LENSAR, “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,” He adds, “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.
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.