Healthcare Industry News: metabolic disease
News Release - November 13, 2006
Lenstec Receives FDA Clearance to Begin Clinical Trial of Softec HD IOLMonofocal Intraocular Implant Joins Tetraflex Presbyopic IOL to Position Lenstec as an Emerging Leader in U.S. Market for Cataract Replacement Lenses
ST. PETERSBURG, FL--(Healthcare Sales & Marketing Network)--Nov 13, 2006 -- AAO Annual Meeting -- Lenstec, Inc. -- a provider of technologically advanced lens implants and devices used in cataract and refractive surgery -- today announced that the U.S. Food and Drug Administration has granted the company an Investigational Device Exemption (IDE) to begin a clinical trial of the Softec HD Posterior Chamber Intraocular Lens (IOL).
Already approved for use throughout the European Union, the Softec HD is an aberration controlled bi-aspheric IOL designed to replace the human crystalline lens following cataract removal in patients 21 years of age and older. It joins Lenstec's expanding Precision Series(TM) line of monofocal and accommodating IOLs, which will be on display Nov. 10-14 at the Annual Meeting of the American Academy of Ophthalmology (AAO) in Las Vegas (booth #3638).
The new U.S. clinical trial will be based on implants performed on 300 eyes. Patient enrollment will begin this month at leading vision surgery centers nationwide.
"The Softec HD is designed to provide cataract surgeons and their patients with a superior alternative to lenses produced under less stringent ISO standards," said Lenstec Vice President Jim Simms. "Lenstec spent much of the last decade helping other IOL providers ramp up their manufacturing operations. We're uniquely familiar with our competitors' approach, and ready to take on the U.S. market with premium lenses that are second to none."
The Softec HD is inserted through a small (2.5 mm to 3.00 mm) clear corneal incision using standard posterior chamber IOL insertion techniques. Based on the company's proprietary manufacturing technology, Premium Series lenses are designed to improve predictability in cataract surgery by reducing the variability (i.e., tolerance or margin of error) inherent in any manufactured lens. The lens configuration was developed to reduce variability up to 300 percent compared to cataract replacement lenses manufactured in accordance with ISO standards.
Variability is measured as the difference between a lens' labeled prescription and its actual power. Thanks to Lenstec's high precision manufacturing process, the Softec HD is available with a tolerance of just 0.125D, and in highly precise 0.25 D increments (from +18.0 to +25.0). "Our goal is to provide a lens with unparalleled precision and improved surgical predictability," Simms added.
Intraocular Lens Implants (IOLs) are used to treat cataracts -- a vision disorder characterized by cloudy or opaque areas in the eye's natural lens that usually develop gradually with advancing age. Environmental factors, metabolic diseases and certain medications can also accelerate cataract formation. Cataract surgery involves replacing the eye's damaged lens with a tiny prescription implant. An estimated 2.5 million people in the U.S. undergo IOL cataract surgery annually, and an estimated 10-15 million IOLs are implanted worldwide each year.
Lenstec, Inc. is a leading provider of medical devices used by ophthalmic surgeons to treat vision disorders. The company designs, manufacturers and distributes a wide range of intraocular lens (IOL) implants and lens injection systems, including the Softec HD IOL, and Tetraflex presbyopic IOL. Proprietary lens manufacturing technology enables the company to produce premium lenses with reduced variability and improved surgical predictability. Founded in 1992, Lenstec is dedicated to advancing possibilities for ophthalmic surgeons and their patients worldwide. More information about Lenstec is available at www.lenstec.com.
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