ArthroCare gets FDA market approval for Parallax acrylic resin cartridge

By Elaine Rigoli

Tampa, Fla., March 30 - ArthroCare Corp. said it received clearance from the Food and Drug Administration to market its Parallax acrylic resin cartridge with Tracers that works with the Parallax Integrated Delivery System (IDS).

The Parallax IDS is the first fully enclosed device used to mix and deliver bone cement during vertebroplasty and kyphoplasty procedures, the company said.

Vertebroplasty has been used for more than 10 years in the United States to treat painful vertebral compression fractures, which can result from severe osteoporosis and benign or malignant lesions such as metastatic cancers and myleoma, according to a news release.

It is estimated that more than 750,000 people per year suffer from vertebral compression fractures.

Typically, vertebroplasty is performed under fluoroscopic guidance using a standard set of tools that include acrylic bone cement, a cement delivery system and access needles.

Currently, cement is prepared, poured into the delivery system and then injected into the vertebra through a properly positioned needle, filling the spaces within the bone. The cement then hardens and stabilizes the vertebra.

Current cement delivery systems often require complicated cement mixing equipment, expose the operating room staff to toxic monomer and deliver inconsistent cement mixing results, according to the release.

The Parallax IDS uses a self-contained cement cartridge that contains precise amounts of monomer and polymer, along with a mating reservoir, the company said.

The cement cartridge locks into the Parallax IDS reservoir, and through a "plunging" motion, it fills the reservoir with cement in a consistent fashion so that it is ready for injection.

Austin, Texas-based ArthroCare develops, manufactures and markets minimally invasive surgical products.

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