Healthcare Industry News: kyphoplasty
News Release - March 30, 2006
ArthroCare Receives FDA Clearance for Latest Vertebroplasty Innovation to Help Treat Vertebral Compression FracturesFully Enclosed Parallax Acrylic Resin Cartridge with TRACERS(R) Designed to Improve Procedures
AUSTIN, Texas--(HSMN NewsFeed)--March 30, 2006--ArthroCareŽ Corp. (Nasdaq: ARTC ), a multi-business medical device company that develops minimally invasive surgical products, announced today 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.
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."
The Parallax IDS is the latest in a line of innovative products from ArthroCare Spine that continue to advance the field of vertebroplasty by delivering a number of industry firsts:
- EZFlow(TM) Cement Delivery System, the first cement delivery system;
- Clear-View(TM) Bulls-Eye Needles, the only needle with guided placement under fluoroscopy;
- Diamond Tip Needle with Threaded Cannula, the only cannula with "threads" that provide easier access to dense bone; and
- Parallax Acrylic Resin with TRACERS-Ta, the only tantalum opacified bone for vertebroplasty.
Founded in 1993, ArthroCare Corp. (www.arthrocare.com) is a highly innovative, multi-business medical device company that develops, manufactures and markets minimally invasive surgical products. With these products, ArthroCare targets a multi-billion dollar market opportunity across several medical specialties, significantly improving existing surgical procedures and enabling new, minimally invasive procedures. Many of ArthroCare's products are based on its patented Coblation technology, which uses low-temperature radiofrequency energy to gently and precisely dissolve rather than burn soft tissue -- minimizing damage to healthy tissue. Used in more than four million surgeries worldwide, Coblation-based devices have been developed and marketed for sports medicine; spine/neurologic; ear, nose and throat (ENT); cosmetic; urologic and gynecologic procedures. ArthroCare also has added a number of novel technologies to its portfolio, including Opus Medical sports medicine, Parallax spine and Applied Therapeutics ENT products, to complement Coblation within key indications.
SAFE HARBOR STATEMENTS
Except for historical information, this press release includes forward-looking statements. These statements include, but are not limited to, the company's stated business outlook for fiscal 2006, continued strength of the company's fundamental position, the strength of the company's technology, the company's belief that strategic moves will enhance achievement of the company's long term potential, the potential and expected rate of growth of new businesses, continued success of product diversification efforts, and other statements that involve risks and uncertainties. These risks and uncertainties include, but are not limited to the uncertainty of success of the company's non-arthroscopic products, competitive risk, uncertainty of the success of strategic business alliances, uncertainty over reimbursement, need for governmental clearances or approvals before selling products, the uncertainty of protecting the company's patent position, and any changes in financial results from completion of year-end audit activities. These and other risks and uncertainties are detailed from time to time in the company's Securities and Exchange Commission filings, including ArthroCare's Form 10-K for the year ended Dec. 31, 2005. Forward-looking statements are indicated by words or phrases such as "anticipates," "estimates," "projects," "believes," "intends," "expects," and similar words and phrases. Actual results may differ materially from management expectations.
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