NexStent Recall: Not for All?

Washington, DCBoston Scientific is recalling its NexStent carotid artery products because part of the stent's delivery system can detach and cause injury, U.S. health officials said on August 14, 2008.

NexStent was approved in October 2006 for patients with clogged neck arteries, which carry blood between the heart and the brain. The stent is threaded up to the neck with a catheter through a small incision made in the groin.

According to the FDA, the stent uses one of two delivery systems called the Monorail and Over the Wire. The recall, which includes NexStent products made from June 2007 to May 2008, applies to the Monorail system as well as the stent itself. The agency said the recall does not affect stents that have already been implanted.

On its website, the FDA says Boston Scientific's artery-opening stents were recalled due to a defect that can cause part of the devices to break off during surgery. The tip of the device used to implant the stent can break off and may damage the blood vessel wall or lead to stroke or internal injury. The problem could also require emergency surgery to remove the tip.

The mesh-metal tubes are used to prop opening arteries after they have been cleared of fatty plaque deposits.

Representatives of Boston Scientific said that patients who already have NexStent are not at risk because problems with the nickel-titanium tubes only occur during placement. Since 2003, manufacturers have gradually replaced bare-metal stents with drug-coated stents.

The FDA says the company notified its customers about the voluntary recall in a June 6 letter. The company said the recall applies to more than 2,200 devices (although the Wall Street Journal reported 2,700 devices recalled) distributed to hospitals worldwide between June 2007 and May 2008 and all US hospitals have responded to the recall.

The Wall Street Journal also reported that Boston Scientific's studies of its next-generation Taxus Liberte stent are based on flawed data. According to the Journal, the company's analysis of its clinical trials gave undue advantage to the stent, which is currently under review by the FDA.

Meanwhile, Boston Scientific announced mid-August that it proposes to close its manufacturing plant in Tullamore, Ireland next year, cutting 240 jobs.