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New carotid guiding sheath receives US FDA and CE Mark approval

St Jude Medical : 09 May, 2008  (New Product)
St Jude Medical has received US FDA clearance and European CE Mark approval of the Strada Carotid Guiding Sheath, a flexible tube through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries.
The Strada Carotid Guiding Sheath is designed specifically to provide easier and faster access to challenging carotid anatomy.

Each year, an estimated 350,000 people in the USA undergo either surgery or a procedure in which a stent, a tiny mesh tube, is inserted to restore blood flow through the carotid arteries.

The carotid arteries are vessels in the neck that supply blood to the brain, face and scalp. In carotid artery disease, a build-up of fatty deposits, or plaque, on the inside walls of the arteries can reduce or restrict blood flow to the brain. Plaque build-up can also lead to an embolism, where a clot or plaque that breaks away from the site at which it formed and lodges ‘downstream’ in an artery to block blood flow. In both cases, the lack of oxygen- and nutrient-rich blood to the brain increases the risk of stroke, which can result in brain damage, death or other harm.

While carotid artery disease has traditionally been treated with surgery, less invasive interventional treatments using balloon angioplasty and stenting are increasingly used to clear blockages and restore blood flow in the carotid arteries. In these treatments, the physician inserts a sheath into an opening in an artery in the upper thigh or the arm and guides it through the arteries to the blockage in the neck. The sheath serves as a conduit for delivering catheters, stents and other artery-opening tools.

'Physicians consistently comment that gaining access through difficult anatomy is the hardest and most time-consuming part of carotid interventional procedures,' said Frank Callaghan, president of the St Jude Medical Cardiovascular Division. 'The Strada Carotid Guiding Sheath is designed specifically to give physicians easier and faster access to blocked regions of the artery. Patients may benefit from reduced procedure times.'

'The Strada Carotid Guiding Sheath is a versatile sheath that is particularly adaptable to the tortuous carotid anatomy,' said Theodore Schreiber, MD, specialist-in-chief, vice president of Cardiovascular Development and division chief of Clinical Cardiology, Detroit Medical Center. 'It is a valuable addition to the tools available to physicians for the treatment of carotid artery disease with balloon angioplasty and stenting.'

The Strada Carotid Guiding Sheath is engineered with five distinct transition zones to provide flexibility on the far, or distal, end of the sheath, and support on the near, or proximal, end of the sheath. The sheath’s construction provides kink resistance for added confidence in navigating challenging anatomy. The Strada Carotid Guiding Sheath is available in 80 and 90cm working lengths.
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