Carl Zeiss Meditec AG Receives FDA Clearance for the IOLMaster 500 Biometer
Published: Nov 08, 2010
DUBLIN, CA--(Marketwire - November 08, 2010) - Carl Zeiss Meditec today announced that the IOLMaster® 500, the newest biometer used to calculate all necessary eye measurements for optimal lens selection for cataract surgery procedures, has received marketing clearance from the U.S. Food and Drug Administration. With dual measurement capabilities, composite signal filtering and user-interface advancements, the IOLMaster 500 is now twice as fast as previous platforms and increases the percentage of measurable eyes, even for patients with dense cataracts.
"Since we introduced the first IOLMaster to the ophthalmic community more than a decade ago, we have continued to incorporate features that optimize ease-of-use and clinical outcomes," said Ludwin Monz, CEO of Carl Zeiss Meditec. "Today, we are pleased to offer the newest and most advanced IOLMaster, which incorporates new algorithms and user-friendly enhancements, resulting in greater efficiency, clinical accuracy and overall performance."
Launched in 2000, the IOLMaster was the first automatic biometry system available which did not make contact with the patient's eye. There are now more than 11,000 units in the world today, making the IOLMaster® the Gold Standard for cataract biometry. The new IOLMaster 500 features several advanced new capabilities, including:
- Increased Speed: In individual practice studies, the new IOLMaster 500 has been shown to complete all measurements in as few as 80 seconds*.
- Dual-mode Measurements: Axial length and keratometry calculations can be collected simultaneously, at the push of a button.
- Composite Signal Filtering: New sound filtering technology excludes poor readings and increases the percentage of cataract patients that can be measured.
- Seamless Data Integration with the Synergy Ultrasound A-scan: This time-saving feature allows easy workflow integration of A-scan ultrasound biometry for difficult cases, such as extremely dense cataracts.
- Easy Data Transfer to the Holladay Consultant Program: The Holladay II formula has become very popular among physicians in North America.
- New Graphical User Interface: With green, red and yellow "traffic light" reporting, technicians of all experience levels can achieve highly accurate diagnostic results.
Collectively, these enhancements allow physicians and their technicians to achieve accurate axial length measurements for more patients than ever before, while significantly reducing measurement time.
"Anything that improves patient outcomes in cataract surgery is a win-win for the physician and for the patient," said Alice Epitropoulos, MD, Co-Founder of the Eye Center of Columbus and Assistant Clinical Professor at The Ohio State University. "The IOLMaster 500 not only has a higher success rate of measuring axial length in dense cataracts but it also provides the most accurate axial length readings, resulting in expected post-surgical visual outcomes. This new platform significantly improves accuracy, speed and convenience in my practice while giving me confidence in determining the best post-surgical outcomes for my patients."
Carl Zeiss Meditec AG (ISIN: DE 0005313704), which is listed on 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 which enable doctors to improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat ophthalmic diseases. In the field of Neuro/ENT surgery, the Company provides innovative visualization solutions. Carl Zeiss Meditec's medical technology portfolio is rounded off by promising future technologies such as intraoperative radiotherapy.
The Company's approximately 2,100 employees generated revenue of about EUR 600 million in fiscal year 2007/08 (ended Sept. 30). The headquarters of Carl Zeiss Meditec are located in Jena, Germany. In addition to other subsidiaries in Germany, the Company is represented by over 50 percent of its employees at sites in the USA, Japan, Spain and France.
Thirty-five percent of Carl Zeiss Meditec's shares are in free float. The remaining 65 percent are held by Carl Zeiss AG, one of the world's leading groups engaged in the optical and opto-electronics industry. The five independently run business segments of Carl Zeiss AG operate in the future-oriented markets "Medical and Research Solutions," "Industrial Solutions" and "Lifestyle Products." Carl Zeiss AG is headquartered in Oberkochen, Germany. During fiscal year 2007/08 (ended Sept. 30) the company generated revenues of about EUR 2.7 billion. Carl Zeiss has around 13,000 employees in more than 30 countries, including more than 8,000 in Germany.
For further information please visit our website at: www.meditec.zeiss.com
* Based on single-practice study conducted by Oliver Findl, MD, Vienna Institute for Research in Ocular Surgery, Vienna, Austria.
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