A Medical Device Daily
Boston Scientific (Natick, Massachusetts) has recalled some of its carotid artery stents due to a defect that can cause part of the devices to break off during surgery.
The FDA said Thursday that the recall affects NexStent products manufactured between June 2007 and May 2008. The recall does not affect stents that have already been implanted, the FDA said.
The tip of the device used to implant the stent can break off and may damage the blood vessel wall or lead to stroke, the FDA said in a notice on its web site. The problem also could require emergency surgery to remove the tip.
The FDA approved the NexStent in 2006 for patients with clogged carotid arteries, which carry blood between the heart and the brain. The stent is made from a combination of nickel and titanium.
Boston Scientific alerted doctors to the voluntary recall in a June 6 letter, according to the notice posted to the FDA's web site.
The stent uses one of two delivery systems — the Monorail and Over the Wire, according to the FDA. The recall applies to the Monorail system as well as the stent itself.
NexStent, which features a rolled mesh design for flexible sizing, was launched in February 2007.
Boston Scientific got some more unwelcome news earlier this week when the Wall Street Journal reported allegations that the research that went into claims of clinical success for its next-generation drug-eluting stent, the Taxus Liberté, is based on flawed data.
The 2006 study of the device, already sold overseas, is currently being reviewed by FDA.
"Boston Scientific's claim was based on a flawed statistical equation that favored the Liberté stent," the newspaper said, noting the equation is known as the Wald interval.
Using a number of other methods of calculation — including 14 available in off-the-shelf software programs — the Liberté study would have been a failure by the common standards of statistical significance in research, the WSJ said.
Boston Scientific spokesman Paul Donovan told Reuters: "The trial met its primary endpoint and did so using statistical methods approved by the FDA, and the FDA has reviewed the trial results and the analysis and has validated both."
Pediatric CT vendor summit set
The Alliance for Radiation Safety in Pediatric Imaging (ARSPI; Reston, Virginia) will host a pediatric CT vendor summit to discuss product development to standardize radiation dose estimation settings and display language for pediatric CT scanners Aug. 20, from 9 a.m.-4 p.m. EDT, at Cincinnati Children's Hospital.
Summit participants will also explore how vendor provided education for technologists can promote better understanding of the unique steps required to safely perform CT scans on children.
"Children are not just 'smaller adults.' Their bodies are different and require a different approach to imaging. The purpose of this summit is to work with the vendors to institute a different method to base estimates of radiation dose captured at the time of the CT scan," said Marilyn Goske, MD, chair of ARSPI, past president of the Society for Pediatric Radiology (SPR; Reston), and Silverman Chair for Radiology Education at Cincinnati Children's Hospital. "This summit is an example of how all imaging stakeholders can work together to ensure that our youngest patients everywhere receive the safe, effective imaging care that they deserve."
The summit will feature presentations by representatives from the Alliance, including the American College of Radiology (REston), SPR, American Society of Radiologic Technologists (Albuquerque, New Mexico), and American Association of Physicists in Medicine (College Park, Maryland), as well as the FDA and the Medical Imaging and Technology Alliance (Arlington, Virginia).
Representatives from every major medical imaging manufacturer are expected be in attendance.