Abbott (NYSE:ABT) won PMA clearance from the Food & Drug Administration for its TECNIS Multifocal 1-Piece intraocular lens, which the federal watchdog approved for treating cataract patients.
The Abbott Park, Ill.-based medical products conglomerate said the lens, which is implanted in the eye after the removal of the cataract-occluded natural lens, corrects presbyopia. That’s a condition in older patients the prevents the eye from adjusting its focal length.
The device was also cleared for reimbursement for presbyopia-correcting procedures by the Centers for Medicare and Medicaid Services, according to a press release. Abbott spokesman Steve Chesterman told MassDevice that the FDA’s Jan. 22 clearance was for a supplemental PMA for the one-piece version of the lens. The three-piece version’s PMA application was approved in January 2009, Chesterman said.
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MassDevice Staff Website The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
The lens is the fruit of Abbott’s whopping $2.8 billion acquisition of Advanced Medical Optics in February 2009, which heralded its intention to grab a stake in the vision care market. In September Abbott snapped up another multifocal IOL maker, Visiogen Inc., for $400 million. Visiogen’s Synchrony IOL, also designed to correct presbyopia in cataract patients, is undergoing clinical trials in the U.S. and has already landed CE Mark approval in the European Union, where it’s been on the market since January 2009. The FDA is also reviewing the device.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
