Saturday, May 01, 2004
CAROTID STENTING...
Stent recommended to prevent strokes
A panel of scientific experts cautiously approved a new stent Wednesday that is intended to prevent strokes by opening a channel in either of the two arteries that feed the brain.
Stents, small mesh-like tubes, have been used for a decade to prop open plaque-plugged coronary arteries. The devices are put in place by a catheter threaded through the groin and guided to the plugged site.
Doctors who have participated in clinical trials of the device say placing the tiny props in one of the two carotid arteries is less invasive than a 50-year-old surgical procedure, carotid endarterectomy, in which the artery is opened and plaque is scraped away from interior walls. About 200,000 Americans a year undergo the surgery.
Full approval is expected by July. The stent and protection devices are manufactured by Cordis. The company is putting physicians through a pretty rigorous program before allowing them to place the device. This consists of training on a simulator to assure compentency in carotid angiography, as well as managment of the device itself. Once that goal has been reached the first five stents placed will have to be proctored. If they do well only then will the device be released to the physician to place as they see fit.
The company not only does this for patient safety, but because of the liability they can face if such a device is misused. I will be interested in following this as the stent becomes more widely available. I fear that the results of the much-lauded SAPPHIRE trial will be "diluted" when more carotid stenting is performed. |
Stent recommended to prevent strokes
A panel of scientific experts cautiously approved a new stent Wednesday that is intended to prevent strokes by opening a channel in either of the two arteries that feed the brain.
Stents, small mesh-like tubes, have been used for a decade to prop open plaque-plugged coronary arteries. The devices are put in place by a catheter threaded through the groin and guided to the plugged site.
Doctors who have participated in clinical trials of the device say placing the tiny props in one of the two carotid arteries is less invasive than a 50-year-old surgical procedure, carotid endarterectomy, in which the artery is opened and plaque is scraped away from interior walls. About 200,000 Americans a year undergo the surgery.
Full approval is expected by July. The stent and protection devices are manufactured by Cordis. The company is putting physicians through a pretty rigorous program before allowing them to place the device. This consists of training on a simulator to assure compentency in carotid angiography, as well as managment of the device itself. Once that goal has been reached the first five stents placed will have to be proctored. If they do well only then will the device be released to the physician to place as they see fit.
The company not only does this for patient safety, but because of the liability they can face if such a device is misused. I will be interested in following this as the stent becomes more widely available. I fear that the results of the much-lauded SAPPHIRE trial will be "diluted" when more carotid stenting is performed. |
