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Home » Baxter’s Artiss sealant wins FDA clearance for face-lift procedures | Regulatory Roundup

Baxter’s Artiss sealant wins FDA clearance for face-lift procedures | Regulatory Roundup

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Baxter

Baxter International Inc. (NYSE: BAX) won an expanded indication for its Artiss fibrin sealant, making it available for use during in sealing tissue flaps during face-lift surgeries.

Artiss first won FDA clearance in 2008 for use in adhering skin grafts in wound beds prepared for treating burns in adults and children over the age of one.

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The sealant is also approved for use in burn, reconstructive and plastic surgeries in 15 European countries, according to a press release.

"In traditional face-lift procedures, sutures are used to close the flap of skin at its edge, often leaving a space underneath the tissue that can lead to post-operative complications," according to the release. "Artiss sets within 60 seconds, giving surgeons time to manipulate and accurately position the skin flap. Artiss contains blood plasma proteins essential to clot formation."

The Deerfield, Ill.-based company recently posted double-digit growth for its second quarter ended June 30, amounting to $629 million in earnings on sales of $3.5 billion, representing an 11 percent increase in sales and a 17 percent increase in profits over the second quarter of 2010.

Regulatory Roundup

  • LED Dental wins CE Mark for screening device
    LED Dental Inc. landed CE Mark approval in the European Union for its flagship Velscope Vx oral screening device for locating and identifying abnormal tissue that may not be visible to the naked eye. Clinical studies showed that including the Velscope device during a traditional head and neck exam helped locate lesions, including cases of dysplasia, that were missed when not using the device.
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  • Cellvizio 100 laser system wins FDA clearance
    Paris-based Mauna Kea Technologies ( EPA:MKEA) announced FDA clearance for its next-gen Cellvizio 100 endomicroscopy system for the GI and pulmonary tracts. The system, which won CE Mark in April 2011, provides physicians with real-time microscopic images of tissue inside the body.
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  • Abbott wins CE Mark for cataract surgery protective gel
    Santa Ana, Calif.-based Abbott Laboratories (NYSE:ABT) won European approval for its Healon EndoCoat ophthalmic viscosurgical device, intended for use as a surgical aid in cataract extraction, intraocular lens (IOL) implantation, corneal transplantation, and glaucoma filtration surgery.
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  • Hemosphere touts CE Mark for Hero graft
    Eden Prairie, Minn.-based Hemosphere Inc. won CE Mark for its Hero vascular access graft for hemodialysis patients. The device is clinically proven to reduce infections by 69 percent compared to hemodialysis catheters in clinical studies.
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