Abbott Laboratories’ emerging vascular device business achieved another milestone this month after the U.S. Food and Drug Administration approved a company-made tool doctors will use to reseal arteries after catheter procedures.
Abbott’s StarClose device is used to reseal arteries that have been punctured to make room for the catheter, a tube that is snaked through an artery and used to perform diagnostic tests or to make way for artery-opening stent procedures. Typically, the catheter is punctured into an artery in the patient’s leg.
The North Chicago-based medical products giant said StarClose uses a tiny flexible clip on the surface of the femoral artery that closes “the artery securely in a matter of seconds.” Standard procedure for vessel closure is manual compression, which can take several minutes to stop bleeding as doctors squeeze the patient’s upper thigh.
Abbott would not disclose a price for the device or provide an estimate for potential annual sales. However, the company said there are an estimated 5.2 million so-called “catheterization procedures” in the United States each year, and about one-third of them use a vessel closure device to stop bleeding.
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The approval comes as Abbott builds a portfolio of vascular devices and is spending more money on research and development at its Redwood City, Calif.-based vascular business. While vascular sales are a fraction of Abbott’s $20 billion in total annual sales, Wall Street analysts see the company’s vascular device sales soaring in the next four years.
In the first nine months of this year, Abbott’s worldwide vascular device sales were $176 million, but an October report by SG Cowen & Co. projected Abbott’s revenue from vascular products to hit $324 million in 2006 and to more than triple to $1.175 billion in 2009.
In September the FDA approved Abbott’s stent for keeping carotid arteries in the neck open, allowing Abbott to become the second U.S. device company in the potentially lucrative market for carotid stents, which are designed to prevent strokes by keeping neck arteries open and clear.
Stents are tiny wire mesh devices that are snaked through arteries via catheter. Much like coronary arteries that lead to the heart, carotid arteries on each side of the neck can become clogged with plaque, causing strokes and other problems. Abbott competes with Indianapolis-based Guidant Corp., which became the first company to win FDA approval of a stent for carotid arteries, in 2004.
The division is also developing drug-coated cardiovascular stents, but is vying to be third to market with a product launch about two years away, the company said. Abbott has funded an ongoing study comparing its experimental drug-coated heart stent to Boston Scientific Corp.’s Taxus, the market’s top seller.
The study, which has enrolled more than 100 patients so far, will eventually involve 1,670 patients at 80 centers, Abbott said. It hopes to win FDA approval for its device, called ZoMaxx, by the end of 2007.
The market for stents is the most lucrative Abbott’s vascular device franchise is trying to enter in the coming years, analysts say. Currently, Boston Scientific and Johnson & Johnson are the only companies that sell drug-coated stents in the $5 billion-a year U.S. market.
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