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LipiFlow for Meibomian Gland Dysfunction and Evaporative Dry Eye Gets Cleared in U.S.

July 11th, 2011 Medgadget Editors ENT, Ophthalmology

TearScience has received FDA clearance for its LipiFlow Thermal Pulsation System that works on meibomian glands to promote the release of lipids to the tear film. The procedure is performed at the doctor’s office and takes about 12 minutes for each eye. LipiFlow delivers heat to the inner eyelid and massage to the outside, which helps unblock the flow of lipids from the cystic meibomian glands.

From the press release:

TearScience’s integrated, in-office system addresses a root cause of evaporative dry eye, the obstructed glands. By assessing the tear film and meibomian gland function, physicians can determine whether MGD is the primary cause of a patient’s evaporative dry eye and whether a patient is a good candidate for the LipiFlow® treatment.

TearScience gained FDA clearance by demonstrating the safety and effectiveness of LipiFlow® through a U.S.-based nine-center randomized controlled clinical trial for the treatment of evaporative dry eye.

TearScience will sell its LipiFlow® and LipiView® Ocular Surface Interferometer devices as a system for eye care practices. The LipiView® enables physicians to visualize the eye’s tear film.

Press release: TearScience Gains U.S. FDA Clearance for the LipiFlow® Thermal Pulsation System for Treating Evaporative Dry Eye…

Product page: LipiFlow Thermal Pulsation System…

(hat tip: MedCity News)

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Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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