OPHTHALMOLOGY INSTRUMENTATION: Carl Zeiss Meditec showcases ophthalmic strength

In its first-ever Media Day on Aug. 19, instrument maker Carl Zeiss Meditec (CZM), a division of Carl Zeiss (Oberkochen, Germany), opened the doors of its Dublin, CA, facility to the press and to selected city officials.

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In its first-ever Media Day on Aug. 19, instrument maker Carl Zeiss Meditec (CZM), a division of Carl Zeiss (Oberkochen, Germany), opened the doors of its Dublin, CA, facility to the press and to selected city officials. Apparently, CZM wants to initiate a more open relationship with the media (and through the media, with its customers). “Companies like Advanced Medical Optics (AMO; Santa Ana, CA) have been holding these media days for seven or eight years now,” said attendee Sean Henahan, editor at Eurotimes, a publication of the European Society of Cataract & Refractive Surgeons (ESCRS; Dublin, Ireland). “I’m hoping to learn something today about CZM’s product portfolio going forward.”

Indeed, the program was designed to highlight the technology being poured into CZM’s ophthalmology products–nine of which are manufactured in the 700-employee facility.

Report from the president

In a videotaped address, CZM president James L. Taylor asserted that CZM’s products enable “improved work flow in diagnostic applications.” He pointed out that Zeiss’s roots go back 160 years and that the company has shipped nearly 10,000 optical-coherence-tomography (OCT) systems in the last five to seven years.

Taylor said he expects a 20% to 40% drop this year in refractive procedures such as laser-assisted in situ keratomileusis (LASIK) that use CZM’s femtosecond VisuMax laser, developed by IMRA America (Ann Arbor, MI). To compete with AMO and Bausch & Lomb (Rochester, NY) in the intraocular lens (IOL) market, CZM has acquired Acri.Tec, well known outside the U.S., and pending FDA approval, will provide IOL services in the U.S. CZM has also initiated a three-year photocoagulation research project to inform plans for an entirely new offering for that market.

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The Cirrus HD-OCT is a spectral-domain, high-resolution version of CZM’s time-domain Stratus OCT system.
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On the financial side, Taylor noted that CZM was approaching $1 billion in revenue. In a news release the company reported consolidated revenue of nearly $648 million in the first nine months of FY 2008 (beginning Oct. 1, 2007), corresponding to a 7% year-on-year increase. The company’s key growth markets–Europe, Middle East, Africa, and Asia-Pacific–more than counterbalance stunted North American sales and the weak U.S. dollar. The release also said that the Ophthalmic Systems business unit accounted for almost half (45.9%) of CZM’s consolidated revenue for this period, even though the unit’s revenue dropped slightly. The Surgical Ophthalmology business unit generated consolidated revenue of $84.7 million (previous year: $56.7 million). The 49.4% increase was attributed mainly to new products and partly to the integration of Acri.Tec.

What happens in Dublin

City of Dublin Mayor Janet Lockhart joined reporters from numerous ophthalmology and technology trade publications on a facility tour, where we learned that CZM is among the 10% of medical device manufacturers that use a completely paperless manufacturing process. Considering that the company manufactures 7000 different instruments (with as many as 300 to 500 individual components per instrument) each year with an estimated 70 to 80 pages required to accompany each one, that is a tremendous savings and just one of the many “green” initiatives proudly undertaken at the facility. In addition to extensive office, research, and development space, as well as the 20,000 sq ft of manufacturing space with a Class 100 optics-assembly clean room and a main assembly line with feeder lines, the facility also houses an eye clinic for medical trials–an important consideration for speeding FDA approval of products that have a typical five-year development cycle.

Technology, instrumentation, and social commitment

The afternoon technology forum explored five primary focus areas of the Dublin facility: microscopes, glaucoma instrumentation, IOL systems, OCT instruments, and data connectivity solutions. At each station, the presentations included testimonials from clinicians.

The OPMI Lumera microscope, used for guiding ophthalmic surgery such as detached retinas and cataract surgery (which is so common that by age 65, 30% of Americans have had cataracts), provides Stereo Coaxial Illumination along the path of its binocular vision for improved brightness, contrast, and depth of focus. CZM estimates that every 20 seconds, someone in the world has cataract surgery with a Zeiss microscope. “This may revolutionize cataract surgery,” said Dr. Howard Fine of Oregon Eye Associates in his testimonial. “I can see things I haven’t been able to see before doing cataract surgery.”

Glaucoma instrumentation includes the GDx scanning laser polarimeter to precisely monitor the progression of the disease in concert with other data, such as that provided by CZM’s OCT instruments and Humphrey eye perimeter instrument.

IOLMaster is the only noncontact instrument to measure the axial length of the eye (biometry) in preparation for IOL implants.

Perhaps the most impressive instrument, though, was the Cirrus HD-OCT, a spectral-domain, high-resolution version of CZM’s time-domain Stratus OCT system. The installed base of Stratus OCT is over 8000, with more than 1000 for Visante OCT; since its release last last year, more than 1000 Cirrus instruments have shipped. While Cirrus provides 27,000 scans per second at a 5 µm resolution (compared to Stratus’s 400 scans per second at a 10 µm), spectral domain technology is so new that its impact on clinical decision making is still being understood. Cirrus enables a 2 mm scan depth for the tissue at the back of the eye, and can display a three-dimensional scan of any selected area.

The coordination of data from various instruments has long been a problem in clinical diagnostics: Clinicians must coordinate OCT, fundus imaging, and perimetry or polarimetry results to plan a course of treatment for patients. To smooth this process, CZM is offering its VISUPAC Star System, a connectivity solution that assists in displaying, analyzing, and archiving the various data sets.

The event concluded with an overview of CZM’s community support programs, including the Blind Babies Foundation (San Francisco) and Vision 2020: The Right to Sight (www.v2020.org), a global initiative for the elimination of avoidable blindness.

–Gail Overton

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