FDA Clears LENSAR’s IntelliAxis-L Laser System’s Toric Intraocular Lens Alignment Guidance

LENSAR Inc., a global developer of next-generation femtosecond laser technology for refractive cataract surgery, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and the European Union CE Mark for IntelliAxis-L.

The company is introducing the new feature with the latest LENSAR Laser System upgrade, Streamline IV. IntelliAxis-L is a unique reference mark that leverages LENSAR’s integrated pre-operative diagnostic capabilities, iris registration, and intraoperative imaging to precisely and permanently identify the location of the steep corneal axis at the capsular plane for intraoperative and postoperative toric IOL alignment. These custom-shaped marks are exclusive to the LENSAR femtosecond laser platform and cannot be duplicated manually or by any other device on the market today.
 
“IntelliAxis-L, our proprietary method of creating customized, data driven laser marks at the capsular plane, represents a significant enhancement to the LENSAR Laser System. With it, our femtosecond refractive laser cataract technology becomes an invaluable tool for those surgeons striving to get better and more reliable outcomes with toric lenses,” said Nicholas Curtis, CEO of LENSAR. “We have made it an objective to be at the forefront of astigmatism management, and to deliver better overall IOL outcomes through proper and effective lens position in refractive cataract surgery. Working closely with surgeons, we continue developing our technology to deliver tangible value to them that ultimately differentiates us from all other platforms.”
 
Coupled with the IntelliAxis-C corneal marking capability, the IntelliAxis-L feature provides another dimension of accuracy in addressing both pre-existing and surgically-induced astigmatism with marks that remain visible postoperatively to help identify any rotation and guide realignment of the toric IOL to its optimal position. IntelliAxis-L joins the suite of total astigmatism management features exclusively available in the LENSAR Laser System with Streamline IV:
 

• Integration of complete corneal measurements, including total corneal refractive power and total corneal astigmatism, to guide placement of arcuate incisions
• Iris registration with automatic cyclorotation adjustment
• Arcuate incision planning leveraging pre-programmed and updated surgeon data
• Surgeon tables used to manage pre-existing and surgically-induced astigmatism

With more than 70 percent of cataract patients presenting with some degree of pre-operative astigmatism and the heightened potential for surgically-induced cylinder, LENSAR’s delivery of innovation in astigmatism management is creating a comprehensive approach for meeting the patient demand for superior refractive outcomes.
 
“The management of total astigmatism is what patients expect from their investment in toric IOLS and with the unique suite of features developed and delivered by LENSAR, it is more achievable than ever before,” said Mark Packer, M.D. “Ensuring the best visual outcomes is mandatory for growth in the premium lens category and LENSAR is leading the way to help surgeons tackle the complexities astigmatism presents.”
 
The LENSAR Laser System with Streamline IV the fourth LENSAR system upgrade in two years, is dedicated to helping surgeons manage astigmatism with extreme treatment planning insights. The only femtosecond cataract laser on the market today developed specifically for refractive cataract surgery, the LENSAR Laser System features quick and easy patient docking, as well as 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 LENSAR Laser System with Streamline IV offers cataract surgeons automation and customization for their astigmatism treatment planning and other essential steps of the refractive cataract surgery procedure with the highest levels of precision, accuracy, and efficiency. These features assist surgeons in managing astigmatism treatment for optimal overall visual outcomes. 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.
 
LENSAR Inc. is a wholly-owned subsidiary of PDL BioPharma Inc.