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Summary of Safety and Effectiveness Data Artecoll™


General Information

    1. Device generic name: Dermal Implant

    2. Device trade name: Artecoll™, PMMA/Collagen Implant

    3. Applicant’s name and address

ARTES MEDICAL, INC.

4660 La Jolla Village Drive, Suite 825

San Diego, CA. 92122 USA


    1. PMA number*

    2. Date of Panel recommendation*

    3. Date of notice of approval to the applicant*


(*to be completed by FDA )

Indications for Use

Artecoll is indicated for the correction of contour deficiencies of soft tissue.



Device Description

Artecoll is composed of PMMA microspheres, 30 to 42 microns in size, suspended in a water based carrier gel composed of 3.5% bovine collagen, 96.5% buffered, isotonic water for injection including 0.3% lidocaine.




0.5 cc syringe contains

Polymethylmethacrylate

120 mg

3.5% Bovine Collagen Solution

0.4 cc

Bovine Collagen




3.5%

Phosphate Buffer




2.7%

Sodium Chloride




0.3%

Lidocaine Hydrochloride




0.3%

Water for Injection




93.2%



Contraindications, Warnings, and Precautions

    1. Contraindications

Artecoll must not be injected if the patient has a positive response to the required Artecoll Test Implant. Refer to Artecoll Test Implant Package Insert for complete instructions for administration and evaluation of the test implant.


Artecoll must not be used in patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.
Artecoll contains lidocaine and must not be used in patients with known lidocaine hypersensitivity.
Artecoll must not be used in patients with a history of allergies to any bovine collagen products, including but not limited to injectable collagen, collagen implants, hemostatic sponges and collagen based sutures, because these patients are likely to have hypersensitivity to bovine collagen in Artecoll.
Artecoll must not be used in patients undergoing or planning to undergo desensitization injections to meat products, as these injections can contain bovine collagen.
Artecoll is contraindicated for use in breast augmentation, and for implantation into bone, tendon, ligament, or muscle.

C.Warnings

An Artecoll Test Implant must be administered and evaluated prior to soft tissue deficiency correction using Artecoll. Refer to Artecoll Test Implant Physician Package Insert.


Artecoll must not be implanted into blood vessels. Implantation of Artecoll into dermal vessels may cause vascular occlusion, infarction, or embolic phenomena.
Artecoll should be used with caution in patients with histories of allergic reactions to other substances, as injectable collagen use has been associated with allergic hypersensitivity responses, especially in patients with such histories.
Use of Artecoll at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the inflammatory process has been controlled.
The safety of Artecoll for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
Artecoll should be used with caution in patients on immunosuppressive therapy.
Patients who are using substances that interfere with platelet function or have any condition that reduces coagulation may experience increased bruising or bleeding at injection sites.

D.Precautions

The injection of Artecoll carries an inherent, yet minimal, risk of infection, as does any transcutaneous procedure. The usual precautions associated with injectable materials should be followed.


After use, treatment syringes and needles may be potential biohazards. Handle accordingly and dispose of in accordance with accepted medical practice and applicable local, state and federal requirements.
Artecoll has an opaque, off-white appearance. In the event that the content of a syringe shows signs of separation and/or appears clear (like water) after being melted, do not use the syringe and notify Artes Medical, Inc. at (858) 550-9999, or toll-free at (866) ARTESINC.

II.Alternative Practices and Procedures

Alternatives to treatment with Artecoll may include:



  • no treatment

  • treatment with injectable bovine collagen fillers (Zyplast, Zyderm; McGhan Medical Corp., Santa Barbara, CA)

  • injection of processed cadaver tissue (Cymetra; Lifecell Corp., The Woodlands, TX) (Fascian; Fascia Biosystems, LLC, Beverly Hills, CA)

  • injection of autologous fat

  • injection of botulinum toxin (Botox; Allergan, Inc., Irvine, CA)

  • laser resurfacing

Of these alternatives, treatment with injectable bovine collagen fillers that do not contain PMMA microspheres has been shown to require retreatment at regular intervals to maintain the desired effect. Processed cadaver tissue is estimated to last three to six months. Autologous fat injections need to be repeated because only a low percentage (<5%) of implanted cells find connection to subcutaneous capillaries of the recipient bed, which is essential for transplant survival. Botulinum toxin injections paralyze the movement of facial muscles for three to six months. They are regarded as safe, but are intended for use only in the upper face. Laser resurfacing can reduce the fine lines and wrinkles that may result from skin aging, but is not intended for treatment of the deep folds for which Artecoll is indicated.



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