MONTREAL, April 16 /CNW Telbec/ - As a result of serious issues with a
product called DermaLive marketed by Vivier Pharma, Canderm Pharma is issuing
an urgent press release to clarify that unlike DermaLive, its product
Artecoll, now called ArteSense, has a proven and consistent safety record.
"It is unfortunate that DermaLive has had these issues. However,
ArteSense's safety record speaks for itself. In no way should our product be
compared to DermaLive," says Barry Vogel, President of Canderm Pharma Inc.
ArteSense (formerly Artecoll) has been on the Canadian market since
August 1998. With over 85,000 syringes used in Canada and over
400,000 patients treated worldwide. In a recently published scientific
paper(1), Artecoll/PMMA microspheres is reported to have one of the lowest
rates of foreign body granulomas.
ArteSense/Artecoll was used in a pivotal FDA study for U.S. approval(2).
The recent five year results were released indicating that the total number of
late adverse events were 2.2% of the 272 wrinkles injected, of which none were
granulomas. Based on the results of this study and its excellent safety record
ArteSense/Artecoll was approved this year under the name Artefill by the FDA
in the United States.
ArteSense/Artecoll is composed of very smooth microspheres of PMMA
(polymethyl methacrylate), with a controlled range size of 32-40 microns
suspended in atelocollagen. PMMA is a material that has been used in the human
body since the early 1930's in such common procedures as dental prostheses,
eye lenses, bone repair, orthopedics and in pacemakers.
In comparison, Dermalive is composed of HEMA (hydroxyethyl methacrylate)
fragments. The polygonal, translucent and irregular particles, 20 - 120
microns in size, appear like clear broken glass gravel under a microscope and
are suspended in hyaluronic acid(3).
ArteSense/Artecoll utilizes the body's natural ability to encapsulate
foreign bodies by the formation of connective tissue surrounding the PMMA
ArteSense/Artecoll is administered only by trained physicians as per
Canderm Pharma's guidelines in ensuring a safe and pleasant treatment for
patients. With permanent fillers such as ArteSense/Artecoll, a trained
physician's expertise is essential in ensuring the correct results.
(1) Avoiding and Treating Dermal Filler Complications, Lemperle et al,
Plas. & Recon. Surg.; Vol. 118, number 3S: September 1, 2006, pgs.
(2) Artefill: A Long-Lasting Injectable Wrinkle Filler Materials -
Summary of the U.S. Food and Drug Adminstration Trials and a Progress
Report on 4 to 5 Year Outcomes; Cohen et al, Plas. & Recon. Surg.;
Vol. 118, number 3S: September 1, 2006, pgs. 64S-76S.
(3) Human Histology and Persistence of Various Injectable Filler
Substances for Soft Tissue Augmentation, Lemperle et al.; Aesth.
Plast. Surg. 27:354-366.
For further information:
For further information: Media contacts: Jennifer Preiato, Public
Relations Manager, Canderm Pharma Inc., (514) 334-3835 ext. 111, 1 877
222-0801 ext.111, firstname.lastname@example.org; Barry Vogel, President, Canderm
Pharma Inc., (514) 334-3835 ext. 108, 1 877 222-0801 ext.108,