The US Food and Drug Administration has cleared to use Abbott's iFS Advanced Femtosecond Laser to create bow-shaped or curved arcuate incisions in corneal surgery, including cataract surgery.
The iFS Laser is currently used to create LASIK flaps and other corneal incisions in the eye and is the fifth generation of IntraLase technology, which has been used in more than 5 million procedures worldwide.
Nearly 3 million patients undergo cataract surgery each year in theUnited States. With this new clearance, the iFS Laser now gives surgeons the ability to make precise, bladeless arcuate incisions during surgery and customize the incision for each individual patient.
Factors such as placement, length, depth and radius of curvature can influence the surgeon's desired change to the cornea. These parameters can be difficult to control through traditional incisions made by hand using surgical knives. Now, using the iFS Laser, arcuate incisions can be performed with greater precision, predictability and customization than is possible with a manual technique.
"This is a major advancement and expansion of our Femtosecond laser technology," said Jim Mazzo, senior vice president, Abbott Medical Optics. "Abbott has been a pioneer in the ophthalmic use of Femtosecond lasers, and this new use of our technology demonstrates our leadership position in this very dynamic and competitive market. This is an important step as we look to utilize Femtosecond laser technology as a potential standard of care during the cataract procedure.”
Study data support that the iFS Femtosecond laser creates arcuate incisions safely and effectively as prescribed by the physician, and complies with applicable safety standards.
This new use of Abbott's iFS Femtosecond laser is available now in the United States.
Abbott Medical Optics is focused on delivering life-improving vision technologies to people of all ages. The company offers a comprehensive portfolio of cataract, refractive and eye care products. Products in the cataract line include monofocal and multifocal intraocular lenses (IOLs), phacoemulsification systems, viscoelastics, and related products used in ocular surgery. Products in the refractive line include wavefront diagnostic devices, femtosecond lasers and associated patient interface devices; excimer laser vision correction systems and treatment cards. Products in the eye care line include disinfecting solutions, enzymatic cleaners, lens rewetting drops and artificial tears.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.