Carl Zeiss Meditec Receives 510(k) Class II Clearance for Humphrey Field Analyzer’s Guided Progression Analysis™ Software
Humphrey Field Analyzer is First Perimetry System to Receive FDA Marketing Clearance to Measure Rate of Visual Field Loss Associated with Glaucoma and Other Diseases
DUBLIN, CA (March 20, 2010) – Carl Zeiss Meditec announced that the U.S. Food and Drug Administration (FDA) has granted a 510(k) Class II clearance for the Humphrey® Field Analyzer (HFA) II-i with Guided Progression Analysis™ (GPA) software. The world’s most widely used automated perimeter is now the only perimeter with GPA software that has received clearance from the FDA to specifically assess the rate of visual field loss over time.
The FDA 510(k) Number K093213 Indications for Use states: “The Carl Zeiss Meditec, Inc. Guided Progression Analysis is a software module for the Humphrey Field Analyzer…that assists practitioners with the detection, measurement and management of progression of visual field loss. It aids in assessing change over time, including change from baseline and rate of change. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to glaucoma. “
“Vision loss from glaucoma is irreversible. Thus, it is vital that doctors be able to differentiate between those patients who are doing well on present therapy and those who are worsening,” said Robert N. Weinreb, M.D., distinguished professor of ophthalmology and director, Hamilton Glaucoma Center of the University of California, San Diego. “Identification of the patients who are progressively deteriorating, and determining their rate of progression is essential for management to prevent vision loss and glaucoma blindness.”
Doctors traditionally have relied upon laborious assessment of a series of the patient’s visual field reports to try and judge whether progression occurred. Even with time and effort, it was difficult to judge the rate at which the fields were changing in order to help decide if current therapy was adequate. GPA applies the same criteria used in the Early Manifest Glaucoma Trial to accurately determine which test points in the visual field have changed, and uses the new Visual Field Index (VFI) to measure the overall rate of visual field progression. GPA automatically summarizes all available visual field test results on a single page and calculates each patient’s rate of visual field deterioration.
With GPA, eye care providers can more closely monitor vision changes for each individual patient to identify when visual field loss is progressing rapidly versus when loss has been stabilized by surgical or pharmacological intervention. Understanding each patient’s rate of progression allows eye care providers to adjust the therapeutic regimen in order to preserve vision.
“The Humphrey Field Analyzer has been the leading perimeter in the eye care industry for more than twenty-five years, and we are excited to have achieved another important milestone with the FDA’s clearance of GPA software,” said Ludwin Monz, CEO of Carl Zeiss Meditec. “Our commitment to leadership in glaucoma continues as we seek to deliver technological enhancements that will allow practitioners to better detect and treat glaucoma, one of the leading causes of vision loss in the world today.”
Humphrey Field Analyzers are used by more eye care providers than any other automated perimeter today, and more than 60 thousand units have been sold since the first models were introduced in 1984. The FDA’s clearance letter for GPA software for the HFA states that the product is “intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including, but not limited to, glaucoma.” GPA software also is available for the Cirrus HD-OCT.
Glaucoma is a degenerative disease of the optic nerve. Most types of glaucoma progress without obvious symptoms, which is why glaucoma is often described as the “sneak thief of sight.” Visual damage is largely irreversible and may lead to blindness. A 2006 study in the British Journal of Ophthalmology estimates that 60.5 million people will be affected worldwide by 2010, increasing to 79.6 million by 2020 as the population ages.
Carl Zeiss Meditec AG, listed in the TecDAX at the German Stock Exchange (ISIN DE0005313704), is one of the world’s leading medical technology suppliers.
The company markets innovative technologies and application-oriented solutions to help doctors to improve the quality of life of their patients. For the diagnosis and treatment of eye ailments the company offers all-in-one solutions including implants and consumables.
In the field of microsurgery the company supplies innovative visualization solutions. Promising future technologies such as intraoperative radiation therapy round out the medical technology portfolio of Carl Zeiss Meditec.
In financial year 2008/09 (30 September) a workforce of about 2,100 generated a turnover of € 640 million. The head office of Carl Zeiss Meditec is at Jena in Germany. In addition to further subsidiaries in Germany over 50% of the company’s employees are located in the USA, Japan, Spain and France.
Thirty-five percent of the Carl Zeiss Meditec shares are in free float. The remaining 65 percent are held by Carl Zeiss, one of the world’s leading groups engaged in the optical and opto-electronics industry. Carl Zeiss offers innovative Medical & Research Solutions, Industrial Solutions and Lifestyle Products. The headquarters of Carl Zeiss AG are located at Oberkochen, Germany. In financial year 2008/09 (balance sheet date 30 September) the Group generated sales of about € 2.1 billion. Carl Zeiss employs almost 13,000 persons, over 8,000 of them in Germany.
For further information visit: www.meditec.zeiss.de