Fri, 20 Oct 2006 16:28:48 EDT
Mentor Granted Canadian Medical Device Licences For MemoryGel Breast Implants - Update
Friday, October 20, 2006; Posted: 02:04 PM
RTTNews) - Mentor Corp. (MNT | charts | news | PowerRating), a supplier of medical products, on Friday revealed that the Therapeutic Products Directorate or TPD of Health Canada has awarded medical device licences for the commencement of the marketing and sales of Mentor's round and contour MemoryGel breast implants for use in augmentation, reconstruction and revision procedures.
The Santa Barbara, California based company noted that, compared to saline to saline breast implants, the gel based MemoryGel implant better imitates the breast. The company intends to make the products available to patients undergoing reconstruction, augmentation and revision procedures.
The Therapeutic Products Directorate informed the company that the documents supporting its applications were found adequate to issue a licence. The terms of the conditions for each of the MemoryGel products require continuation of the Core Study, conducting of physician and patient focus groups regarding the format and content of the approved labeling, conducting a post-approval study and conducting additional pre-clinical testing.
President and Chief Executive Officer of the company Joshua Levine commented, "We are very gratified that, after a thorough review of the clinical and scientific evidence, Health Canada has issued licences for MemoryGel breast implants. In Canada, choices for women seeking breast augmentation and reconstruction had previously been limited. Mentor's MemoryGel breast implants will be a significant additional option for these women."
MNT is currently trading at $47.43, down $0.20 or 0.42%, on a volume of 0.41 million shares.
