FDA clearance for LENSAR Laser System

LENSAR Inc., developer of the next generation LENSAR Laser System^™ for refractive cataract surgery, announced today that the company's laser system has received 510(k) clearance from the United States Food and Drug Administration (FDA) for executing corneal incisions during cataract surgery. The LENSAR Laser System is now cleared by FDA for all the critical components of laser cataract surgery including lens fragmentation, anterior capsulotomy (with or without phacofragmentation) and corneal incisions. The company is currently selling the LENSAR Laser System to cataract surgeons in the U.S., Europe and several other countries around the world.

“The company's advanced imaging guidance technology enables surgeons to execute the precise and self-sealing incisions that play such a critical role in a patient's overall experience and outcome. I commend LENSAR for its ongoing commitment to raising the bar for quality in the area of laser cataract surgery.”

"By securing this regulatory clearance for corneal incisions, LENSAR is now able to offer surgeons another critical tool for optimizing patient safety, satisfaction and outcomes in connection with cutting edge laser cataract surgery," said Dr. Louis "Skip" Nichamin, member of LENSAR's medical advisory board. "The company's advanced imaging guidance technology enables surgeons to execute the precise and self-sealing incisions that play such a critical role in a patient's overall experience and outcome. I commend LENSAR for its ongoing commitment to raising the bar for quality in the area of laser cataract surgery."

LENSAR's novel platform represents the latest scientific breakthrough in cataract surgery, combining the most advanced laser technology with unique product features. The LENSAR Laser System is specifically intended to meet the advancing needs of refractive cataract surgeons and enhance their patients' outcomes. The platform showcases LENSAR's next generation differentiating Augmented Reality technology which consists of proprietary high-resolution 3D-imaging measurement technology that enables precise imaging and biometric measurements of the anterior segment eye anatomy even for dense cataracts. Unlike traditional imaging systems, LENSAR's Augmented Reality platform provides clean, low noise images that are both high contrast and high resolution from the anterior surface of the cornea to the posterior capsule of the crystalline lens, while automating the ability to correct for lens tilt or centration during the customized treatment to accommodate each patient's individual anatomy. In addition, this technology allows the creation of the precise capsulotomy incision size, shape, and location, enhancing effective IOL lens positioning and fitting for each individual patient, leading to optimized patient outcomes.

Importantly, the system's sophisticated phacofragmentation techniques allow for easier and more efficient removal of all grades of cataracts and a major reduction in, or in a large number of procedures complete elimination of the use of the ultrasound energy required in conventional cataract surgery. Furthermore, the entire procedure can take place in a single procedure room and the mobile LENSAR Laser System is easily adaptable to existing surgical facilities, allowing surgeons a never before available level of precision, efficiency, patient comfort, and safety.

"We are pleased with this latest broadening of the cleared indications for the LENSAR system as it demonstrates the continued ability of the LENSAR team to establish strategic development and commercialization objectives and then systematically deliver on those goals," said Nick Curtis, LENSAR's Chief Executive Officer. "At the same time, the continued expansion of FDA-cleared indications provides significant value to the cataract surgeon community and we expect this important regulatory milestone to add to the steadily increasing demand for our system worldwide."

Additionally, the groundbreaking nature of the LENSAR Laser System was profiled on a recent episode of the Emmy Award-winning television show The Doctors. The program included a discussion with Kerry K. Assil, M.D., of the Assil Eye Institute in Beverly Hills, CA, and one of the first cataract surgeons in the U.S. to perform a procedure using the LENSAR Laser System. Dr. Assil provided an overview of LENSAR's platform and the benefits it offers, while highlighting the story of one of his patients who had her vision restored to 20/20 following a procedure with the LENSAR system. You can access clips from this program at: http://www.thedoctorstv.com/videolib/init/7984