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Mentor Hyalite dermal filler

This article was originally published in The Gray Sheet

Executive Summary

Pivotal study commences of the non-animal stabilized hyaluronic acid dermal filler, comparing the device with Medicis' approved Restylane HA filler. Six-month data from the 12-month study will be submitted in support of a planned PMA application for facial wrinkle correction and lip augmentation. The latter application would be a first for an HA filler. Hyalite includes lidocaine anesthetic to alleviate pain during injection. Mentor acquired the device via its August 2003 acquisition of Vitrolife AB subsidiary A-Life (1"The Gray Sheet" Sept. 8, 2003, p. 19)...

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