Vertebroplasty Innovation To Help Treat Vertebral Compression Fractures

Austin, TX - ArthroCare Corp., a multi-business medical device company that develops minimally invasive surgical products, announced it received clearance from the U.S. Food and Drug Administration (FDA) to market its Parallax Acrylic Resin Cartridge with TRACERS that works with the Parallax Integrated Delivery System (IDS).

The Parallax IDS is the industry's first fully enclosed device used to mix and deliver bone cement during vertebroplasty and kyphoplasty procedures.

"The Parallax Integrated Delivery System brings consistency, simplicity and a new level of performance to vertebroplasty procedures," said David Applegate, vice president and general manager of ArthroCare Spine.

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 or benign (hemangioma) or malignant lesions (metastatic cancers, myleoma). 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 vertebrae through a properly positioned needle, filling the spaces within the bone. The cement then hardens and stabilizes the vertebrae.

The Parallax Integrated Delivery System

Current cement delivery systems often require complicated cement mixing equipment, expose the operating room (OR) staff to toxic monomer and deliver inconsistent cement mixing results. The Parallax IDS is the first fully enclosed bone cement delivery system that eliminates these concerns by using a self-contained cement cartridge containing precise amounts of monomer and polymer, and a mating reservoir.

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. In addition to simplifying the cement mixing process, the Parallax IDS also provides precise cement volume control; a large cement reservoir that allows a vertebroplasty to be completed without refilling; and a 17-inch injection tube that minimizes the operator's exposure to radiation.

"Parallax's new cement delivery system for vertebroplasty is impressive," said Jason Stoane, M.D., and neuroradiologist at St. Joseph Hospital in Bellingham, Wash. "A completely closed mixing system that provides consistency and excellent cement visualization is important for procedure safety and outcomes. In addition, the price of the system makes the product advancements even more appealing."

SOURCE: ArthroCare Corporation