Lawmakers Seek Stent Data from Boston Scientific, Johnson & Johnson
Boston Scientific and Johnson & Johnson said on Monday that U.S. lawmakers have requested information from the companies on their drug-eluting stents to treat clogged heart arteries.
In separate, brief statements, Boston Scientific and J&J each said they would provide the information requested to Henry Waxman, chairman of the U.S. House Oversight and Government Reform Committee.
The U.S. Food and Drug Administration in December convened a panel to assess the safety of drug-eluting stents after research showed the devices can cause blood clots months after implantation.
The panel recommended that labels for the devices, sold in the United States by J&J and Boston Scientific, should note that sicker patients who receive stents to treat blocked arteries face a higher chance of developing potentially deadly blood clots than those with simple blockages.
The panel also concluded the benefits outweighed the risks for appropriate patients and called for more research.
Stents are tiny wire-mesh tubes inserted into diseased arteries after they have been unclogged. The drug coating on the metal keeps the vessels from reclogging. Drug-coated stents quickly supplanted the bare-metal variety when they were launched three years ago.
Recently, however, sales of the devices have softened as physicians and patients reassess the risks.
Medtronic and Abbott Laboratories sell drug-coated stents in markets outside of the United States and are preparing to enter the U.S. market.