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)...