FDA Oks TearScience Lipiflow MGD System

Staff
8/15/2011

TearScience Inc. announced that it has received Food and Drug Administration clearance for its Lipi- Flow Thermal Pulsation System for the treatment of meibomian gland dysfunction, also known as evaporative dry eye. The clearance enables TearScience to market and sell Lipi- Flow to eye-care physicians in the U.S. LipiFlow will be available immediately, but on a limited basis in the United States through the end of 2011. LipiFlow removes meibomian gland obstructions by applying directed energy to a patient’s eyelid during a 12-minute in-office treatment. An international workshop on MGD recently stated that the condition may well be the leading cause of dry-eye disease throughout the world. MGD’s role in ocular health is gaining recognition as the industry reaches consensus on a standard definition, classification, diagnosis and therapy for the disease.

Of the more than 100 million dry-eye sufferers worldwide, approximately 65 percent have evaporative dry eye. Common symptoms of the disease include eye irritation, dryness, redness, tiredness and visual disturbances. TearScience says its 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. The FDA clearance followed a U.S.-based ninecenter, 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.

For information, visit tearscience.com.


Biofinity Goes Multifocal
CooperVision recently added the versatility of multifocality to its Biofinity line of monthly replacement contact lenses.

The company says the Biofinity multifocal offers exceptional end-of-the-day comfort and vision quality. It’s currently available in powers of +6 to -8 D and four add powers, +1 D, +1.5 D, +2 D and +2.5 D. CooperVision also says that, in conjunction with the new lens, it’s introduced a new streamlined fitting approach that it developed after getting feedback from contact lens professionals. It hopes the new process makes fitting multifocal lenses easier than ever.

For information, call 1-800-538- 7824 or visit coopervision.com.


High-Def Anterior Segments
Accutome Ultrasound has unveiled the new high definition UBM Plus used for anterior-segment imaging. The company says one of the chief features of the device is its portability; the 48-Mhz probe plugs into a laptop or desktop computer. The UBM Plus also has an all-in-one probe that Accutome says eliminates signal loss to provide sharp images. The system also features tools for data analysis, such as sulcus-to-sulcus and anterior chamber depth measurements, intraocular lens positioning and examination of the angle. The software is also upgradeable.

To use, the device’s software captures 34-second film loops. Then, while reviewing the loops, the user takes a snapshot of a particular image.The built-in reports template pulls these images and data to create detailed reports in seconds, the company says. The system interfaces with electronic medical records, as well.

For information, call 1-800-979- 2020 or visit accutome.com.


Optovue Debuts iWellness and Gets FDA Clearance for iStand
Optovue has launched a new wellness program implemented as a “pay-per-visit” arrangement with eye-care clinicians. The iWellness Exam has been added to the portable new spectral optical coherence tomographer from Optovue—the iVue—launched in 2010. The company expects the incorporation of the new iWellness exam, which scans for both retinal and glaucomatous pathology, to complement the everyday comprehensive eye exam. This pay per-visit model will allow an office to provide better medical care and a wellness-testing option with no capital outlay. Optovue says the diagnostic capabilities of the practice will be greatly enhanced with the implementation of the iWellness program.

The iWellnessExam is non-invasive and can quickly be performed as an initial step in a routine comprehensive eye exam. IWellness images provide a cross-sectional view of the retinal layers with 5-ìm resolution. In addition to the cross-sectional views, the iWellnessExam provides a retinal thickness map and a ganglion cell complex map. These outputs assist in identifying very early signs of disease, or confirm the patient’s ocular health.

Optovue also announced that the new iStand, a multi-directional stand for universal positioning of the iVue SD-OCT system, received FDA 510(k) clearance in June.

The company says the iStand expands the clinical utility of the iVue SD-OCT device delivering enhanced clinical decisions, procedure planning and documentation. The system enables eye-care professionals to follow patients from diagnosis through postoperative care. By mounting the iVue onto iStand, clinicians can now take further advantage of iVue’s compact Size and portability to easily move their OCT between the exam lane, hospital facilities, and satellite offices. The simple, easy-to-use articulating arm facilitates scanning supine patients as well as patients in other positions. For information, visit optovue.com.


More Ways to Do a Duette
SynergEyes says you now have another option for patients who need a soft toric lens, as the powers for its Duette silicone hydrogel hybrid have been expanded. The lens is now available in sphere powers from +6 to -15 D. The company says the Duette uses novel materials for the lens, creating a rigid gas permeable center for clear vision and a soft lens skirt for all-day comfort. The RGP’s material, MaxVu, has a Dk value of 130 and uses a class II UV blocker, while the soft hydrogel skirt has a Dk of 84 and is 32 percent water. The lens’s surface treatment, HealthyEyes, increases wettability and resists protein deposits inorder to maximize comfort, Syn- ergEyes says.For information, call 1-877-SEE- 2012 or visit synergeyes.com.




 
Tranquileyes T
heir Eyes
Eye Eco has added Moisture Release Eyewear to its line of Tranquileyes products. The company says Moisture Release glasses can help patients suffering from dry eye. The new eyewear’s frame has two vented, removable chambers that contain pieces of foam. When the chambers are soaked in water and then placed back in the frame, the water evaporates from the foam, bathing the eyes with humidity.

The glasses also have a foam-padded gasket and bendable nose bridge to seal the eye area and protect it from wind, dust and pollen. The company says this added-moisture minimizes dry-eye symptoms and improves comfort. For information, visit eyeeco.com.


M&S Glare Testing System Enhances Testing Options
M&S Technologies has announced the newest addition to the Smart System line is the Glare Testing System, which provides a consistent technology for measuring the impact of glare on a patient’s vision.Developed and engineered by M&S (patent pending) along with the guidance of Jack Holladay, MD, the glare component offers the eye-care professional an enhanced method to further test patients who complain of poor vision especially while driving at night, the company says.

A first in the industry by M&S, each glare assembly is carefully calibrated to existing luminance standards for testing under glare conditions. With consistency from exam room to exam room and visit to visit, the Glare Testing System is easy to install and utilizes long-life, high-intensity LEDs. It is sold as an option and can be added to any Smart System in use today.

For information, visit mestecheyes.com.