Quantel Medical Inc.'s Optimis Fusion™ Receives FDA 510(k) Clearance
CLERMONT-FERRAND, France, July 9, 2014 /PRNewswire/ -- Quantel Medical today announced FDA 510(k) clearance for its Optimis Fusion integrated laser platform. The Optimis Fusion system combines advanced selective laser trabeculoplasty (SLT) photoregeneration therapy and traditional YAG photodisruption treatments to offer ophthalmologists a versatile armamentarium for treating both cataract and glaucoma in an efficient combination platform.
The Fusion’s unique SLT mode incorporates the most advanced laser technology available to provide a first-choice treatment for managing glaucoma and lowering intraocular pressure. SLT therapy works by targeting melanin-rich cells that absorb the laser energy to induce a healing response, improving the function of the trabecular meshwork. Laser energy is delivered in short, fixed pulses over a large, homogeneous spot size, resulting in no thermal damage. Due to this gentle delivery and lack of permanent destruction to the trabecular meshwork, SLT leaves structures intact, making it a repeatable procedure.
The YAG mode delivers high-performance photodisruption for capsulotomy and peripheral iridotomy surgical procedures. The gaussian laser beam profile allows for precise laser delivery at minimum energy levels, avoiding adverse side effects such as lens pitting. Precise tissue targeting is achieved with the advanced two-point aiming beam, allowing for fast and accurate targeting of the capsule, and an adjustable anterior and posterior offset feature allows for easy focus adjustment in front of, behind, or at the point of disruption.
“We are extremely excited to bring our breakthrough laser platform to the U.S. market,” said Jean-Marc Gendre, CEO of Quantel Medical. “The Optimis Fusion has proven to be a very attractive laser platform since introduction earlier this year in other markets. Driving the acceptance of this product introduction is the ability to combine a 532nm mono spot or multispot retina laser, a unique feature to Quantel’s laser line.”
Integrating the Optimis Fusion with Quantel’s Vitra Monospot and Multispot pattern-scanning retina laser systems, offers comprehensive treatment options for multi-specialty practices looking to treat glaucoma, cataract and retina conditions in one laser platform.
About Glaucoma
Glaucoma is a group of diseases that damage the eye’s optic nerve and can result in vision loss and blindness. Glaucoma can be roughly divided into two main categories, “open-angle” and “closed-angle” (or “angle closure”) glaucoma.
About Cataract
A cataract is a clouding of the lens inside the eye, which leads to a decrease in vision. It is the most common cause of blindness and is conventionally treated with surgery.
About Quantel Medical
Founded in 1993 and headquartered in Clermont-Ferrand, France, Quantel Medical is a global ophthalmic medical device company dedicated to developing leading technologies to improve the treatment of ocular diseases. Quantel Medical has a strong emphasis in research and development, resulting in many first-to-market product introductions and a comprehensive product portfolio of diagnostic ultrasound and surgical lasers for ophthalmologists. These products are available through direct sales operations in the U.S. and France, and through independent distributors in over 80 countries.
Quantel Medical is a division of Quantel (QUA:EN), a world-wide leader in the development of solid-state lasers for scientific and industrial applications. For more information, please visit www.quantel-medical.com.
SOURCE Quantel Medical
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