Tuesday, April 1, 2008

Mentor Corporation Announces FDA Approval of Prevelle Silk: First Dermal Filler to Prove Pain Reduction in the U.S





SANTA BARBARA, Calif., Mar 21, 2008 (BUSINESS WIRE) -- Mentor Corporation (NYSE: MNT), a leading supplier of medical products for the global aesthetic market, today announced that the Food and Drug Administration (FDA) has approved Prevelle Silk. This is the first of a new line of lidocaine containing hyaluronic acid (HA) dermal fillers that Mentor anticipates marketing and distributing globally.

Prevelle Silk is a colorless HA gel with lidocaine that is injected into facial skin to reduce moderate to severe facial lines, folds, and wrinkles. The product is the first in a new line of HA dermal fillers that Mentor is developing with Genzyme Corporation (NASDAQ: GENZ). Lidocaine, a local anesthetic, is added to provide pain relief at the site of the injection. In a controlled clinical study, patients experienced significantly less pain during injection with Prevelle Silk when compared to an HA product that did not contain lidocaine.



Mentor Corporation has forged a strategic development partnership with Genzyme Corporation, a global leader in the development and manufacturing of HA products. Mentor Corporation will market and distribute the products globally. "We believe both patients and physicians will be excited to have an effective dermal filler option with lidocaine to help make the filler injection more comfortable," said Brian Luedtke, Vice President of Global Marketing and Sales of Mentor Corporation. "We believe Prevelle Silk will be an excellent complement to our portfolio of lidocaine containing HA dermal fillers, the second of which is under review with FDA and the third in clinical trial. We will shortly begin targeted launch efforts to experienced dermatology and plastic surgery dermal filler customers and anticipate a broader U.S. commercial launch in combination with our second dermal filler later this year." About Prevelle Silk PREVELLE SILK is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). In clinical studies, adverse events were usually mild to moderate in nature, did not require intervention and lasted seven days or less. The most common side effects included temporary injection site reactions such as swelling, pain/tenderness, redness, and lumps/bumps.

 

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