Advanced angioplasty catheter device to be sold in U.S.

The FX miniRAIL coronary catheter is the first dilatation device to evolve beyond the traditional “wire inside a balloon” design, which allows the rail wire to participate in the dilatation process.One of the largest cardiovascular medical device companies in the …

The FX miniRAIL coronary catheter is the first dilatation device to evolve beyond the traditional “wire inside a balloon” design, which allows the rail wire to participate in the dilatation process.One of the largest cardiovascular medical device companies in the world has put its faith in Israeli technology.

American giant Guidant has acquired Yavne-based Israeli medical device company X-Technologies in a deal that business insiders are calling the largest cash acquisition of an Israeli start-up in the last two years, although the exact price has not been disclosed.

X-Technologies has developed the FX miniRail coronary catheter, a dilation device that is more advanced than the traditional “wire inside a balloon” designs.

The new angioplasty catheter technology developed by X-Technologies opens blockages, while minimizing damage to healthy arterial tissue. The FX miniRAIL, features two metal wires external to an angioplasty balloon which opens coronary arterial blockages with minimal trauma. An integrated pull wire helps to track tortuous vessels, while another steerable guide wire helps anchor the catheter in the lesion. These wires, which are on the outside of the balloon, fracture the plaque as the balloon dilates.

“We are enthusiastic about the potential of the FX miniRAIL, which complements Guidant’s broad line of products for the treatment of coronary artery disease. We have been pleased with feedback on the value of this device from international clinicians and physicians involved in the device’s clinical investigation,” said Dana G. Mead, Jr., president, Vascular Intervention, Guidant Corporation.

“We believe that the features of our FX miniRAIL product line, combined with Guidant’s established presence in interventional markets make this a compelling combination,” said Guy Shinar, president and CEO of X-Technologies. “The progress that we have made to date is a tribute to the outstanding efforts of our dedicated employees.”

The FX miniRAIL received European approval in December 2001 and is currently available in Europe, Asia Pacific, the Middle East and Africa. A pre-market approval (PMA) submission for the FX miniRAIL was filed with the U.S. Food and Drug Administration (FDA) in September 2002.

More than 539,000 angioplasty procedures were performed in 1998, the year for which the most recent figures are available, the American Heart Association said. That?s up 248 percent from 1987. The latest estimates are that the angioplasty market will soon exceed even the current estimate of $5 billion. U.S. cardiologists are faced with a 30-40% rise the number of patients referrals this year.


X-Technologies first developed treatments for restenosis (renewed narrowing or blocking of arteries at the same place as an earlier treatment). The company developed an x-ray catheter that is inserted into the coronary arteries following catheterization to prevent renew plaque buildup, which occurs in 35% of cases. The original technology can treat especially severe blockages, while reducing complications during angioplasty.

X-Technologies’ first products went on sale in Europe last year, and sales have so far reached a few million dollars. In the wake of the recent deal, X-Technologies products will reportedly be sold by Guidant’s European distributors. When the company has received final US Food and Drug Administration (FDA) approval, Guidant will begin selling the products in the US.

Guidant, which has annual revenues of $2.7 billion, is one of the largest cardiovascular medical device companies in the world. It employs 10,000 people and was founded in 1994. Guidant has a network of distributors throughout North America, Asia, Europe, and South America, and offers one of the smallest, most advanced pacemakers on the market.