Lensar Receives CE Mark for Upgrades to Lensar Laser System

Orlando, Fla.-based Lensar Inc., which makes femtosecond laser technology for refractive cataract surgery, has received the CE mark from European Union regulators for a suite of five new application technologies integrated into the company’s flagship product, the Lensar laser system. According to the company, the system is the first femtosecond laser cataract platform to enable automation of key surgical procedure planning and execution elements; the Lensar laser system with the new Streamline application upgrades include: wireless integration with popular topographers, iris registration, cataract density imaging, customized fragmentation patterns and arcuate incision (two semi-circular incisions surrounding the pupil) planning.

“This important approval, following so rapidly on the heels of our U.S. [Food and Drug Administration] clearance, is further evidence of Lensar’s ongoing commitment to speeding innovation to the global market,” said Lensar CEO Nicholas T. Curtis. “The Streamline upgrades to the Lensar laser system include innovative integration of functions to allow surgeons to fully automate and customize critical planning and execution steps of refractive cataract surgery for the first time.”

The Lensar laser system with Streamline will be introduced in the European during the International Congress of German Ophthalmic Surgeons in Leipzig, Germany. The meeting is held from June 11-13.

The Lensar laser system establishes a wireless integration protocol with preoperative diagnostic devices. Wireless data transfer of preoperative corneal measurements from the Cassini corneal shape analyzer to the Lensar Laser System is meant to improve procedure flow and eliminates potential errors from manual entry of data from the device used in the preoperative and surgical planning process. Another feature of the integration with Cassini is the ability to wirelessly transfer the pre-operative un-dilated iris image from the Cassini to the Lensar laser for comparison to the iris image while the eye is fully docked under the Lensar laser at procedure time; and automatic compensation for cyclorotation by adjusting incision placement for improved refractive outcomes. This is meant to eliminate the need to manually ink-mark the eye to identify and adjust for the cyclorotation that may occur when a patient is reclined during surgery. Lensar is working to integrate additional topographers, including the Aladdin Biometer from Topcon Medical Systems Inc.

“Lensar’s integration of preoperative diagnostics represents significant innovation in the femtosecond cataract procedure that we anticipate will result in improved surgical efficiency and outcomes for patients,” said Professor Gerd Auffarth, medical director of the University Eye Clinic in Heidelberg, Germany. “The ability to automate aspects of the procedure addressing astigmatism, including iris registration, arcuate incision planning and steep axis corneal marking, is extremely valuable in delivering the refractive results patients expect from laser cataract surgery.”

Additionally there is an arcuate incision planning table on the laser that includes parameters to define the location, depth and extent of the surgeon’s intended incisions based on individual patient biometric measurements and other factors defined by the surgeon. This capability is hoped to allow surgeons to retain their plan preferences for later use, increasing surgical operating room efficiency. Also included in the Streamline upgrade is a steep-axis corneal-marking function, providing non-refractive landmarks to support the surgeon’s management of astigmatism. The new integrated cataract density imaging, which automatically categorizes the cataract to a pre-programmed, surgeon-customized fragmentation pattern depending upon the density of the cataract, allows the surgeon to automatically isolate fragmentation to the nucleus.

“Incorporating the surgeon preferences for fragmentation patterns and energy levels based upon automated cataract density analysis helps to ensure safe and efficient cataract removal,” said Detlef Holland, M.D., medical director of Nordblick Eye Clinic in Bellevue, Germany. “While laser fragmentation is a hallmark of the femtosecond cataract procedure, the Lensar laser system’s unique preprogramming capabilities may directly benefit both patient comfort during the procedure and the visual outcomes achieved by the procedure.”

The Lensar laser system with Streamline will be distributed in Europe by Topcon Europe Medical B.V. The system was first introduced in 2012.