Sheath for Carotid Arteries Blessed by Feds
The new Strada carotid guiding sheath, manufactured by St. Jude Medical, received the blessing of the Food and Drug Administration as well as the European CE mark. The new tool is designed to assist clinicians with the placement of devices, such as leads and stents, to support opening of the carotid artery. St. Jude posted news of the approval on their website.
The sheath is available in both 80 and 90 cm working sheaths. It was designed to provide flexibility on the end of the sheath through the integration of five transition zones. Those zones also provide support for the sheath’s distal end. The Strada was also created to minimize the likelihood of kinks which further supports navigation through difficult arterial anatomy.
The versatility of the sheath supports placement in carotid arteries, which can be torturous to navigate. This may enable more rapid treatment, through faster access to the site of interest within the artery. These features should also reduce the overall time to complete procedures.
Over 350,000 people undergo procedures every year to place various devices in the carotid artery. This is expected to increase as more and more noninvasive approaches are developed. Restriction of the carotid arteries can reduce the amount of blood flow to the brain, increasing the risk of stroke or embolism.
May 19, 2008 Related topics: Product Approval & Certification, Cardiology