LensAR receives FDA clearance for Streamline™, providing fully automated and customized planning and execution steps for refractive cataract surgery with the Cassini corneal shape analyzer
Apr 1, 2015
LENSAR to Unveil LENSAR Laser System with Streamline™ at ASCRS Meeting Booth #1750
Orlando, FLA., 01 April, 2015 – LENSAR, Inc., a global leader in next generation femtosecond laser technology for refractive cataract surgery, today announced it has received 510k clearance from the U.S. Food and Drug Administration (FDA) for a suite of five new application technologies integrated into the company’s flagship product, the LENSAR Laser System. The LENSAR Laser System with Streamline™ is the first femtosecond laser cataract platform to enable automation of several surgical procedure planning and execution elements with the introduction of five new application upgrades that include:
“The addition of the Streamline advanced technology suite solidifies our LENSAR Laser System as the femtosecond platform of choice for today’s refractive cataract surgeon,” said LENSAR CEO Nicholas T. Curtis. “The five distinct upgrades to the platform include innovative integration of functions unique to the LENSAR Laser System that, for the first time, allow surgeons to fully automate and customize critical planning and execution steps of refractive cataract surgery.”
About the LENSAR Laser System with Streamline™
LENSAR Laser System is the first femtosecond laser cataract platform to establish a wireless integration protocol with preoperative diagnostic devices. The company is initiating this capability with the Cassini Corneal Shape Analyzer enabling for the wireless transfer of data from pre-operative corneal measurements to the LENSAR Laser System. This new integration eliminates potential errors that can occur from manual entry of data from the device used in the pre-operative and surgical planning process. The integration with Cassini enables the capture of preoperative iris registration data and maps it to the image of the eye obtained under the laser at procedure time, eliminating 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.
“Creating an integrated technology approach to the femtosecond cataract procedure is something we refractive cataract surgeons have been waiting for, and it doesn’t surprise me at all that LENSAR was the company to get it done,” said Jonathan Solomon, M.D. surgical/refractive director at Solomon Eye Associates in Maryland. “I anticipate LENSAR’s Streamline will improve not only OR efficiency and patient experience during the procedure, but may also improve outcomes by minimizing the human factor inherent in manual data input or physically marking the eye pre-operatively.”
Additionally, for the first time surgeons have access to an arcuate incision planning table on the laser that includes parameters to define the location, depth and extent of the surgeon’s intended arcuate incisions based on individual patient biometric measurements and other factors defined by the surgeon. The arcuate incision planning capability allows surgeons to retain their plan preferences for later use, increasing surgical operating room efficiency.
The Streamline upgrades also introduce integrated cataract density imaging, which automatically categorizes the cataract to pre-programmed surgeon-customized fragmentation pattern depending on the density of the cataract and allows the surgeon to automatically isolate fragmentation to the nucleus. This first-in-market innovation may have a positive impact on efficiency and procedure time.
“LENSAR has given the reigns to the surgeon to make the laser-assisted refractive cataract procedure customized to both patient and surgeon’s needs,” said Robert Weinstock, M.D., director of cataract and refractive services at the Eye Institute of West Florida and The Weinstock Laser Eye Center. “The ability to preprogram the laser just one time with a surgeon’s specific preferences for fragmentation patterns based upon an automated cataract density analysis and customized arcuate incision plans may increase the efficiency and accuracy for every procedure thereafter, enhancing patient comfort and, ultimately, visual outcomes.”
Streamline upgrades including the arcuate incision planning, cataract density imaging and customized fragmentation patterns will be made available to all LENSAR users. The full Streamline technology suite will be available to practices currently using both the LENSAR Laser System and the Cassini Corneal Shape Analyzer.
LENSAR has placed more than 140 systems with customers around the world since its introduction in July of 2012, and the system has been used in nearly 60,000 cataract surgery procedures.
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For more information please contact Jeroen Cammeraat, CEO +31 70 399 31 12 or j.cammeraat@i-optics.com
LENSAR, Inc., is a global leader in next generation femtosecond laser technology for refractive cataract surgery. The LENSAR Laser System offers cataract surgeons precision, accuracy, and efficiency while optimizing overall visual outcomes. LENSAR’s proprietary Augmented Reality technology — reconstructed 3-D imaging, measurement, and guidance system — offers quick and easy patient docking and provides high-resolution ocular images in a single scan. 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, phaco energy. The LENSAR Laser System also offers the industry’s smallest laser footprint and thoughtful ergonomic design that accommodates most operating rooms.
With the recent approval of five application upgrades, offered as Streamline™ upgrade, the LENSAR laser cataract system becomes the first to offer automation and customization of essential steps of the refractive cataract surgery procedure. The LENSAR Laser System, has been cleared by the FDA for anterior capsulotomy, lens fragmentation, and corneal and arcuate incisions. For other indications it is an investigational device limited by U.S. law to investigational use only. For more information, please visit www.lensar.com.
To schedule an interview or booth tour, please contact:
Media Contact: Investor Inquiries:
Liana Miller for LENSAR Peter J. Mariani, CFO
liana@engagedcommunication.net (888) 536-7271
949-276-8920
article references
LensAR receives FDA clearance for Streamline™, providing fully automated and customized planning and execution steps for refractive cataract surgery with the Cassini corneal shape analyzer
