FDA Approvals: Onyx, Fraxel Laser, Parallax With TRACERS-TA

Yael Waknine

July 29, 2005

July 29, 2005 — The U.S. Food and Drug Administration (FDA) has approved a liquid embolic system for use in the presurgical treatment of arteriovenous malformations, a skin resurfacing laser for the treatment of melasma, and a tantalum-opacified bone cement for use in vertebroplasty and kyphoplasty procedures.

Liquid Embolic System (Onyx) for Presurgical Stabilization of AVMs

On July 21, the FDA approved a liquid embolic system (Onyx, made by Micro Therapeutics, a majority-owned subsidiary of ev3) for use in the presurgical treatment of arteriovenous malformations (AVMs). Endovascular embolization can reduce the size and vascularity of the AVM, thereby facilitating and increasing the safety of resection.

The embolic material is a mixture of ethylene vinyl alcohol copolymer dissolved in dimethyl sulfoxide that contains micronized tantalum powder for fluoroscopic visualization. It is delivered in liquid phase via microcatheter to the target lesion where it transforms into a solid polymer cast to seal off blood vessels and reduces the risk of rupture during resection.

The device was previously approved for use in the European Union.

Laser (Fraxel) for Fractional Resurfacing Treatment of Melasma

On July 27, the FDA approved a new indication for a skin resurfacing laser (Fraxel, made by Reliant Technologies, Inc.), allowing its use for the treatment of melasma associated with pregnancy, female hormonal activity, and certain drugs.

According to a company news release, melasma is resistant to traditional therapies, with traditional laser and pulsed-light treatments considered unsatisfactory because of poor results, significant downtime, or the risk of adverse events.

Use of fractional photothermolysis is intended to resolve excessive pigmentation at the dermal junction without aggravating surrounding melanocytes, thereby preventing inflammatory posttreatment responses and improving healing.

The approval was based in part on a study showing that use of the device resulted in marked to significant improvement of melasma in 7 (70%) of 10 female patients, as assessed by two independent investigators.

In a second 10-patient study, facial areas treated with the device showed statistically significant improvements in the appearance of melasma and quality of skin texture, relative to use of topical therapy alone (control). All device-treated areas demonstrated some degree of improvement, compared with 50% of controls. No serious adverse events were observed in any of the studies.

The device was previously approved by the FDA in 2004 for skin resurfacing and correction of periorbital wrinkles and pigmented lesions (lentigos, solar lentigos, and dyschromia) and in 2003, for use in dermatologic procedures requiring soft tissue coagulation.

Titanium-Opacified Bone Cement (Parallax With TRACERS-TA) for Spinal Procedures

On June 17, the FDA approved a new indication for a tantalum-opacified bone cement (Parallax Acrylic Resin with TRACERS-TA, made by Arthrocare Corp.), allowing its use in vertebroplasty and kyphoplasty procedures. Vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The tantalum particles appear as dark spots under fluoroscopic imaging, thereby enabling visualization of cement flow and placement within the bone cavity. According to a company news release, use of the cement is expected to increase patient and procedure safety.

The product was previously approved by the FDA in 2004 for use in cranioplasty.

Reviewed by Gary D. Vogin, MD

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