Lensar Receives FDA Clearance for IntelliAxis-L Toric Intraocular Lens Alignment Guidance

Source: Lensar

Friday, November 10, 2017 | Product Releases


Lensar announced it has received FDA 510(k) clearance and CE Mark approval 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 preoperative 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,” Nicholas Curtis, CEO of Lensar, said in a company news release. “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% of cataract patients presenting with some degree of preoperative astigmatism and the heightened potential for surgically-induced cylinder, Lensar’s rapid delivery of innovation in astigmatism management is unmatched in the industry today, creating a comprehensive approach for meeting the patient demand for superior refractive outcomes, Mr. Curtis said.

“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,” Mark Packer, MD, said in the news release. “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.”


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