NEW YORK (Reuters Health) – Privately held X Technologies Inc. has won U.S. marketing clearance for a new device, fulfilling the conditions necessary for the firm to be acquired by cardiovascular device giant Guidant Corp. under a deal announced earlier this year.
X Technologies’ device is used to help clear stents that clog after being placed into coronary arteries. Guidant announced the marketing clearance of the device on Monday, saying it now expects to close the acquisition of the firm this quarter.
Called the FX miniRAIL, the device was already approved in Europe and other parts of the world. It features two metal wires located outside angioplasty balloons which are threaded through clogged arteries in order to restore blood flow. Angioplasty procedures are typically performed as preparation for implanting stents into arteries and to help clear re-clogged arteries.
“The FX miniRAIL has demonstrated positive results in the treatment of de novo lesions and in-stent restenosis,” Dana G. Mead, Jr., Guidant’s president of vascular intervention, said in a statement. “We are enthusiastic about the potential of the FX miniRAIL and look forward to soon offering this unique technology to physicians worldwide.”
Indianapolis-based Guidant is one of the world’s biggest producers of stents. In early January, it abandoned its plans to acquire Cook Group Inc. after a clinical trial failed to show Cook’s drug-coated stent was significantly more effective in preventing re-clogging than Guidant’s own product. Guidant cut its 2003 financial outlook the next day.
X Technologies is based in Tustin, California and Yavne, Israel.
On the closing of the acquisition, Guidant will make a $60 million cash payment and forgive a $4.5 million extension of credit. Additional payments may be made in the future based on sales criteria.
In announcing the planned acquisition in March, Guidant said it does not expect the purchase to hurt its profit.
Guidant’s shares were up 17 cents at $40.12 on the New York Stock Exchange in early afternoon trading on Monday.
Separately on Monday, Guidant said it would stop making a product used to treat aneurysms after it was linked to 12 deaths and dozens of serious injuries. (See separate Reuters Health report, June 16, 2003.)
The company last week agreed to pay $92.4 million and pleaded guilty to 10 felony counts for misleading federal regulators about the deaths and injuries linked to the device, which is called the Ancure Endograft system and is used to prevent the heart’s main artery from rupturing.