ZEISS MEL 90 excimer laser receives U.S. FDA approval; completes Corneal Refractive Workflow

Rhea-AI Summary

ZEISS Medical Technology announced FDA approval for its MEL 90 excimer laser, receiving simultaneous approval for treating myopia, hyperopia, and mixed astigmatism. The technology integrates with the VISUMAX 800 with SMILE pro, enhancing ZEISS' laser vision correction market leadership.

The MEL 90 features Triple-A (Advanced Ablation Algorithm) technology, offering high accuracy and tissue-saving ablation. It can ablate 1 diopter in 1.3 seconds during LASIK procedures at 500 Hz. The system includes an active eye tracker, intuitive interface, and flexible touch screen positioning for improved workflow efficiency.

This approval completes ZEISS' Corneal Refractive Workflow, providing U.S. surgeons with an integrated system for enhanced patient outcomes and practice efficiency. The technology is immediately available in the U.S. market.

Positive

• FDA approval received for all three major eye correction indications simultaneously
• Fast ablation speed - 1 diopter in 1.3 seconds during LASIK procedures
• Integration with existing VISUMAX 800 system enhances workflow efficiency
• Advanced Triple-A technology offers high accuracy and tissue-saving features

Negative

• None.

The excimer laser complements the ZEISS VISUMAX 800 with ZEISS SMILE pro, extending ZEISS' LVC market leadership with treatment for myopia, hyperopia, and mixed astigmatism.

DUBLIN, Calif. and JENA, Germany, Jan. 13, 2025 /PRNewswire/ -- ZEISS Medical Technology announced today that the MEL^® 90 received approval from the U.S. Food and Drug Administration (FDA), giving the excimer laser technology simultaneous approval for all three major indications, including myopia, hyperopia and mixed astigmatism (a condition where both hyperopic and myopic correction is required). The ZEISS MEL 90 fully integrates into the Corneal Refractive Workflow to offer U.S. surgeons a fast, reliable, and streamlined surgery experience, complementing the VISUMAX^® 800 with SMILE^® pro from ZEISS to help further broaden a surgeon's refractive business with improved patient attraction and positive clinical outcomes.  

"The increasing global adoption of laser vision correction reflects the advancements and positive impact the technology continues to have on the quality of life for patients," says Magnus Reibenspiess, Head of Strategic Business Unit Ophthalmology at ZEISS Medical Technology. "With the integration of the ZEISS MEL 90, surgeons can confidently care for their patients with greater workflow efficiency and performance with enhanced outcomes."

"ZEISS continues to break new ground as a leader in the LVC market, reflecting our ongoing commitment to and support of U.S. surgeons and patients with the latest refractive innovation that helps set practices apart and provides more options to more patients," says Andrew Chang, Head of Global Sales for ZEISS Medical Technology. "With the availability of the ZEISS MEL 90 in the U.S. market, surgeons can now offer an integrated workflow of refractive technology to help reach new patients and provide excellent outcomes for them."

"The FDA approval of the ZEISS MEL 90 excimer laser is a game changer for refractive surgery in the U.S. This advanced technology, with its Triple-A ablation algorithm and fast ablation speed, sets a new benchmark for precision, safety, and efficiency. I am particularly impressed by the system's ability to simplify treatment planning while delivering highly predictable and tissue-conserving results. The integration of the ZEISS MEL 90 with the ZEISS VISUMAX 800 femtosecond laser opens new doors for streamlined workflows and optimal patient outcomes. This approval marks an exciting chapter for surgeons and patients alike," says Dr. John Doane, Refractive Surgeon, Discover Vision Centers, Kansas City, MO.

Reliable Outcomes: The ZEISS MEL 90 offers Triple-A (Advanced Ablation Algorithm), which is a single ablation profile for a wide range of sphero-cylindrical (SCA) corrections that simplifies treatment planning. Triple-A offers a high degree of accuracy, reproducibility and predictability, as well as advantages such as tissue-saving ablation. Its preinstalled functions also offer surgeons optimal support for achieving excellent treatment results and gentle treatments of standard, higher and lower levels of ametropia and astigmatism.

Fast Ablation Speed: The ZEISS MEL 90 offers a truly customized power package. When performing LASIK for myopia at 500 Hz, the ZEISS MEL 90 can intra-operatively ablate 1 diopter in as little as 1.3 seconds.¹ Intuitive system guidance and speedy treatment planning allow for additional time savings. The ZEISS MEL 90 excimer laser technology is equipped with an active eye tracker which delivers an excellent response time, providing a high level of treatment safety with very stable results.

Easy to Use: New capabilities of the ZEISS MEL 90 excimer laser greatly simplify the interactions between the surgeon, the assisting staff and the system technology. The excimer laser can be configured to precisely match the surgeon and the OR team's needs. The system's simple, intuitive graphic user interface supports fast treatment procedures, and the touch screen can be flexibly positioned wherever it is needed to enable the surgeon to have good ergonomic sitting posture throughout an operation. A second, optional touch screen can be configured to optimally complement the treatment routine of the OR team. An HD video port, network printer connection, and PDF export capabilities offer additional workflow support.

With the ZEISS MEL 90, the company expands its offerings for U.S. refractive clinics and helps support the improvement of clinical outcomes and patient satisfaction through onboarding, training, service support and ZEISS Practice Development Consulting.

The ZEISS MEL 90 excimer laser is currently available in the U.S. For more information, visit www.zeiss.com/us/mel-90

¹LASIK myopia, optical zone 6 mm.

Not all products, services or offers are approved or offered in every market and approved labeling and instructions may vary from one country to another. For country-specific product information, see the appropriate country website. Product specifications are subject to change in design and scope of delivery as a result of ongoing technical development. The statements of the healthcare professionals reflect only their personal opinions and experiences and do not necessarily reflect the opinion of any institution that they are affiliated with. The healthcare professionals alone are responsible for the content of their experience reported and any potential resulting infringements. Carl Zeiss Meditec AG and its affiliates to not have clinical evidence supporting the opinions and statements of the health care professionals nor accept any responsibility or liability of the healthcare professionals' content. The healthcare professionals have a contractual or other financial relationship with Carl Zeiss Meditec AG and its affiliates and have received financial support.  

Brief profile

Carl Zeiss Meditec AG (ISIN: DE0005313704), which is listed on the MDAX and TecDAX of the German stock exchange, is one of the world's leading medical technology companies. The Company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The Company creates innovative visualization solutions in the field of microsurgery. With 5,730 employees worldwide, the Group generated revenue of €2,066.1m in fiscal year 2023/24 (to 30 September).

The Group's head office is located in Jena, Germany, and it has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research (CARIn) in Bangalore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the Company's presence in these rapidly developing economies. Around 39 percent of Carl Zeiss Meditec AG's shares are in free float. Approx. 59 percent are held by Carl Zeiss AG, one of the world's leading groups in the optical and optoelectronic industries.

For more information visit our website at www.zeiss.com/med

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SOURCE Carl Zeiss Meditec AG

FAQ

What conditions can the ZEISS MEL 90 excimer laser treat after FDA approval?

The ZEISS MEL 90 excimer laser is FDA-approved to treat myopia (nearsightedness), hyperopia (farsightedness), and mixed astigmatism.

How fast can the ZEISS MEL 90 perform LASIK procedures?

During LASIK procedures for myopia at 500 Hz, the MEL 90 can ablate 1 diopter in as little as 1.3 seconds.

What is the Triple-A technology in the ZEISS MEL 90 laser system?

Triple-A (Advanced Ablation Algorithm) is a single ablation profile that simplifies treatment planning, offering high accuracy, reproducibility, and tissue-saving ablation for sphero-cylindrical corrections.

How does the ZEISS MEL 90 integrate with existing ZEISS technology?

The MEL 90 fully integrates with the VISUMAX 800 with SMILE pro system, creating a complete Corneal Refractive Workflow for improved surgical efficiency and outcomes.