Date: 2014-09-15
Type of information: Initiation of patient enrollment
phase:
Announcement: initiation of patient enrollment
Company: Covidien (Ireland)
Product: Pipeline™ embolization device
Action mechanism:
Disease: unruptured intracranial aneurysms
Therapeutic area: Cardiovascular diseases - Cerebrovascular diseases
Country: USA
Trial
details: * On September 15, 2014,Covidien announced the start of enrollment in two clinical trials designed to further underscore the safety and effectiveness of the company’s advanced neurovascular solutions. Baptist Medical Center in Jacksonville, Florida, treated the first patient enrolled in the PREMIER Prospective study, an international Investigational Device Exemption (IDE) clinical study to evaluate the Pipeline™ embolization device in smaller unruptured intracranial aneurysms. The PREMIER study will enroll up to 141 patients in 20 global sites and is designed to assess the safety and effectiveness of the Pipeline device in the treatment of unruptured, small and medium wide-necked intracranial aneurysms (IAs).
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