Lensar announced it has received 510(k) clearance from the FDA 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 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,” Nicholas Curtis, CEO of Lensar, said in a company news release. “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,” Gregory Parkhurst, MD, FACS, of Parkhurst NuVision, said in the news release. “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.