Carotid string sign (a tiny, long segment of contrast in the true lumen of the artery).Previously placed stent in target artery.Low to moderate risk for adverse events from carotid endarterectomy.The safety and effectiveness of the Xact Carotid Stent System has NOT yet been established in patients with the characteristics noted below. When multiple stents are required, stent materials should be of similar composition. Special consideration should be given to those patients with recently active gastritis or peptic ulcer disease. The appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure as suggested in these instructions. In patients requiring the use of antacids and / or H2-antagonists before or immediately after stent placement, oral absorption of antiplatelet agents (e.g. Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures. The long-term performance (> 1 year) of the Xact Carotid Stent System has not been established.Īs with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm, or rupture. The safety and efficacy of the Xact Carotid Stent System has not been demonstrated with embolic protection systems other than the Emboshield Embolic Protection System. Refer to instructions supplied with all interventional devices to be used with the Xact Carotid Stent System for their intended uses, contraindications, and potential complications. Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device. Lesions in the ostium of the common carotid artery.Patients with uncorrected bleeding disorders.Patients with a known hypersensitivity to nickel-titanium.Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of the Guiding Catheter / Introducer Sheath, BareWire guide wire, Emboshield Delivery Catheter, Filtration Element, and / or Retrieval Catheter.Patients in whom anticoagulant and / or antiplatelet therapy is contraindicated. ![]() Patients must have a reference vessel diameter ranging between 4.8 mm and 9.1 mm at the target lesion.Ĭontraindications associated with angioplasty must be considered when using the Xact Carotid Stent System. Patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or ≥ 80% for asymptomatic patients by ultrasound or angiography), located between the origin of the common carotid artery and the intra-cranial segment of the internal carotid artery AND ![]() 1, 2007, In Brief).The Xact Carotid Stent System (Xact), used in conjunction with the Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the criteria outlined below: "The safety profile is really the most important ," Jeff Nelson, president of Thoratec's cardiovascular division, told "The Gray Sheet." Thoratec expects to finish a trial to support a "destination therapy" indication for HeartMate II by the middle of this year (1"The Gray Sheet" Jan. Compared to adverse event rates observed in the clinical trials of Thoratec's first-generation HeartMate VE, the rate of percutaneous lead infections declines 90%, stroke is down 50%, and bleeding requiring surgery is down 40%. In the trial, 75% of patients met the primary endpoint of remaining eligible for transplant for at least 180 days or completing a cardiac transplant. Results of a 133-patient pivotal trial, submitted to FDA in December, were announced at the American College of Cardiology Scientific Sessions in New Orleans March 24-27 by Leslie Miller, M.D., Georgetown University. Thoratec's HeartMate II: Thoratec expects FDA to approve its continuous-flow left-ventricular assist device as a "bridge to transplant" in heart failure patients this summer.
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