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News Breaks
February 13, 2013
08:52 EDTSTJFDA announced Class I recall of St. Jude's Amplatzer delivery system
The FDA yesterday afternoon announced a Class I recall for St. Jude Medical's Amplatzer TorqVue FX Delivery System. The Amplatzer system is used to assist the attachment, loading, delivery, and deployment of Amplatzer Occluder devices. Amplatzer Occluder devices are used to close openings between the two upper chambers of the heart. The FDA stated that in a small number of cases, the distal end of the core wire of the TorqVue FX Delivery System could potentially fracture. The product may cause serious adverse health consequences, including death, the agency added.
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May 23, 2013
05:44 EDTSTJSt. Jude Medical study of EnligHTN shows sustained blood pressure reduction
St. Jude Medical announced that the company's EnligHTN Multi-Electrode Renal Denervation System provides a safe, rapid and sustained reduction in blood pressure measurements after one year. Patients enrolled in the EnligHTN I trial had an average blood pressure of 176 / 96 mmHg and patients were drug-resistant, meaning their blood pressure could not be controlled through medication. At one year, patients treated with the EnligHTN Renal Denervation System experienced an average systolic blood pressure reduction of 27 mmHg points when measured in an office setting.
May 20, 2013
11:12 EDTSTJSt. Jude Medical to evaluate defibrilator lead related to reported death
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May 16, 2013
08:05 EDTSTJSt. Jude Medical's 3-D vessel reconstruction system approved in Europe
St. Jude Medical announced CE Mark approval of its Ilumien Optis PCI Optimization System, a new technology designed to provide physicians with a comprehensive disease assessment tool for treating patients with coronary artery disease. St. Jude Medical is the only company to provide these tools together in an integrated platform.
May 14, 2013
08:09 EDTSTJSt. Jude Medical announces first patient enrolled in EnligHTN III study
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