20.03.2006 16:00:00
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WaveLight's DataLink Nomogram Program Demonstrates Superior Outcomes Among ALLEGRETTO WAVE(R) User Community
In a paper presented this morning at the American Society ofCataract and Refractive Surgery (ASCRS) annual meeting, David A.Wallace, MD, medical director of LA Sight in Los Angeles, reviewed hisexperience using DataLink pooled nomogram recommendations for hisfirst cases using the ALLEGRETTO WAVE. Dr. Wallace reported his 20/20UCVA rate had increased to 94 percent from 84 percent for his first 65myopic eyes (up to -7D), once able to use surgeon-specific data(requiring a 2-month minimum follow-up from first cases). He creditsthe improvement to the combination of laser stability, accuracy andnomogram refinement with DataLink. This compared with a 91 percent20/20 rate for comparable eyes in FDA studies.
"DataLink helped ease the angst that any surgeon faces whentransitioning to a new laser system, and provided a starting nomogrambased on aggregate data from similar lasers, not guesswork," Dr.Wallace stated. "The fact that I achieved an 84 percent 20/20 ratewith my first cases was reassuring, and seeing this rate increase to94 percent with surgeon-specific nomogram guidance was indeedcompelling. In addition, my enhancement rate has decreased to 3.2percent, nearly two-thirds less than my prior wavefront-guidedplatform."
DataLink is an easy-to-use, web-based software application thatprovides surgical planning and outcomes analysis specifically for theALLEGRETTO WAVE excimer laser system. The program allows surgeons toaccess a secure database to gain valid starting nomograms, customizetheir own nomograms and compare their surgical outcomes against thoseof the broader ALLEGRETTO WAVE user community. WaveLight is the firstknown laser manufacturer to provide a data processing and benchmarkingtool of this scale to its physician customers.
"Participation in the DataLink project has been advantageous forone reason: it works. Results have been excellent and keep improvingas users contribute more data into the system," stated Guy M.Kezirian, M.D., F.A.C.S., president and founder of SurgiVisionConsultants, Inc. "Our benchmark is for each center to achieve evenbetter outcomes than in the FDA trials. Because those results weregenerated from multiple sites without surgeon-specific nomograms, thisshould be possible, and the results so far suggest that it is. Thegoal is to suppress enhancement rates to a point where they almostdon't exist. We're not there yet, but we're getting close."
"DataLink is representative of WaveLight's philosophy to empowersurgeons with an open sharing of data, with the end result beingclinically superior outcomes," said Wade Tetsuka, President ofWaveLight, Inc. "We are pleased at the rapid adoption of DataLinkamong our user base as their participation enables WaveLight tomonitor outcomes in order to maintain the quality of results we expectfrom the ALLEGRETTO WAVE."
DataLink was initiated in March 2005 and is a complimentaryservice available to all accredited refractive surgeons using theALLEGRETTO WAVE. The SurgiVision DataLink (WaveLight Edition) is aproduct of SurgiVision Consultants, Inc. of Scottsdale, AZ.
The ALLEGRETTO WAVE was the first refractive laser to receiveconcurrent approvals for the treatment of myopia up to -12 diopterswith astigmatism of up to -6 diopters and hyperopia up to +6 diopterswith astigmatism of up to +5 diopters, not exceeding a mean sphericalequivalent of +6 diopters.
WaveLight AG (ISIN DE 000 512 5603)
WaveLight AG, listed in Deutsche Borse AG's Prime Standard sinceJanuary 2003, develops, produces, and markets a high-quality,end-to-end product portfolio in the fields of ophthalmology andaesthetics. WaveLight's market success is based on its innovativerange of products that are the technology leaders in their areas ofapplication and its broad-based sales network featuring both own saleschannels and strategic partners. In the past fiscal year 2004/2005,WaveLight generated revenues of EUR 80.7 million and EBIT of EUR 8.8million. Its average growth rate (CAGR) since 2000/2001 amounts to 35percent for revenues and 63 percent for EBIT.
Further information on WaveLight is available at:www.wavelight.com
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