ArteFill® Permanent Filler
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FDA Approved Permanent Filler
ArteFill® is the first and only non-resorbable aesthetic injectable implant approved by the FDA. The product is indicated for the correction of facial wrinkles known as nasolabial folds, or smile lines. Unlike existing dermal fillers that are completely metabolized by the body, ArteFill® represents the first product in a new category of non-resorbable dermal fillers providing a permanent support structure for enduring wrinkle correction.
Permanent Injectables For Soft Tissue Engineering
Suneva Medical holds U.S. and international patents to protect its unique injectable microsphere technology for soft tissue engineering.
Technology Platform
The ideal substance for the lasting treatment of wrinkles, scars, and other soft tissue defects is one that is biocompatible and safe, is stable at the implantation site, keeps its volume and remains pliable, does not cause protrusion of the skin or mucosa, induces target other key medical indications.
Nasolabial fold before and one year after
injection with
Composition Formula
Microspheres
Polymethylmethacrylate (PMMA), in use since 1945, is the most commonly used artificial substance in the medical field. The size, shape and smoothness of the microspheres are important to ensure the product’s biocompatibility. All PMMA microspheres in ArteFill® are sieved and washed multiple times to yield precision-filtered spheres that meet FDA quality standards. In studies to assess the body’s cellular response toward various implant shapes, spherical implants were found to initiate the least response compared to more irregular shapes.
PMMA Microsphere as a Scaffold for Connective Tissue Deposition
Collagen
Bovine collagen has been used to treat wrinkles and scars for over 20 years. Suneva Medical uses bovine collagen derived from calf hides obtained from a controlled, U.S. herd with stringent FDA compliant procedures. In their product formulations, ultra-purified collagen is a carrier substance that prevents the microspheres from clumping together during new tissue ingrowth within the first 3-6 months after injection.
Aesthetic Tissue Engineering: Mechanism of Action
When the suspension of collagen carrying the microspheres is injected into the dermis directly below and along a patient’s facial wrinkle or scar, the microspheres stimulate the growth of the patient’s own connective tissue and promote the natural production of human collagen around each of the injected microspheres as the bovine collagen carrier is being absorbed over 3-6 months. Aesthetic results are visible immediately and continue to improve during the tissue remodeling period. The PMMA microspheres act as a scaffold for the deposition of human collagen, completely replacing the injected bovine collagen. Thus, the enduring aesthetic effect is achieved through the biological effect of the microspheres stimulating the natural production of human collagen (tissue engineering). 80% of the final tissue augmentation consists of the patient’s own collagen producing a soft and natural result.
PMMA Microspheres as a Scaffold for Connective Tissue Deposition
ArteFill®/Artecoll U.S. Clinical Trial Results
ArteFill®/Artecoll was evaluated in a prospective, multi-center, controlled, randomized, double blind clinical study, in which subjects received either ArteFill®/Artecoll or a commercially available collagen implant control (Zyderm®/Zyplast®) for the treatment of soft tissue defects of the face. A total of 251 subjects (128 ArteFill®/Artecoll, 123 control) were treated at 8 Dermatology or Plastic Surgery Centers in the U.S. Follow-up periods for both safety and efficacy were at 1, 3, and 6 months, with a final 12-month safety evaluation. The efficacy data, measured by masked observers using a photographic facial fold assessment scale, demonstrated a significant improvement with ArteFill®/Artecoll compared with collagen at 6 months (p <0.001). At 6 months, the investigator success ratings and the subject satisfaction ratings were superior for Artecoll (p <0.001). In the ArteFill®/Artecoll group, 12-month follow-up was obtained for 111 subjects (86.7 %) and showed persistence of significant correction. ArteFill®/Artecoll treatments showed fewer adverse events compared to the control group, although the difference was not statistically significant.
On February 28, 2003, the U.S. Food and Drug Administration’s General and Plastic Surgery Devices Advisory Panel recommended that ArteFill®, the next generation product meeting strict FDA quality requirements, be approved, with conditions for marketing in the United States. ArteFill® is expected to become the first permanent injectable wrinkle filler to gain FDA approval.
Call our office today at 858-453-7224 or our toll-free line, 877-336-5900, to schedule your personal consultation.
Learn more about permanent fillers:
- Learn about ArteFill’s Most Innovative Product Award
- Read a Wall Street Journal Article about ArteFill®
References:
Detailed information on Suneva Medical’s technology and clinical experience has been published in leading medical, aesthetic, plastic, and reconstructive surgery journals.
- Cohen SR, et al. ArteFill®: A Long-Lasting Injectable Wrinkle Filler Material-Summary of the U.S. Food and Drug Administration Trials and a Progress Report on 4-to 5-year Outcomes. Plast. Reconstr. Surg. 2006; 118; No. 3S: 64S-76S.
- Broder KW and Cohen SR. ArteFill®: A Permanent Skin Filler. Expert Rev. Med. Devices (3), 2006;281-289.
- Cohen SR and Holmes RE. Artecoll: A Long-Lasting Injectable Wrinkle Filler Material: Report of a Controlled, Randomized, Multicenter Clinical Trial of 251 Subjects. Plast. Reconstr. Surg. 2004;114:964-976.
- Lemperle G, Holmes RE, Cohen SR et al. A Classification of Facial Wrinkles. Plast. Reconstr. Surg. 2001;108:1735-1750
Disclosures:
- Suneva Medical – Dr. Steven Cohen is on the medical advisory board, an investigator, and a minor shareholder.
Call FACESplusTM at 858-453-7224 or our toll-free line, 877-336-5900, to schedule your personal consultation or to learn more about cosmetic and plastic surgery, laser procedures, skin care, and non-surgical options.
FACESPlusTM offers the following plastic surgery and cosmetic procedures and treatments for the San Diego and La Jolla, CA areas: Face Lift, Tummy Tuck, Rhinoplasty, Liposuction, Breast Augmentation, Botox, Skin Care, Laser Hair Removal and much more.
