Medtronic commences new global CoreValve study
19 July 2012 16:55 in Medical Company Product News
Medtronic has announced the commencement of a new global clinical trial evaluating its European-approved CoreValve System.
The first patient has been enrolled for the study, which will compare the device with surgical aortic valve replacement in patients with severe aortic stenosis who are at intermediate risk to undergo open-heart surgery.
Its purpose is to assess the potential usefulness of the device as a treatment for less sick patients who typically are treated with open-heart surgical aortic valve replacement.
The study will be the largest global, randomised, controlled trial on transcatheter aortic valve implantation and will enrol around 2,500 patients at up to 75 clinical sites.
Principal investigator Dr Pieter Kappetein, professor of cardiothoracic surgery at the Erasmus Medical Center in Rotterdam, said: "This study represents a significant opportunity to bring a new therapy to physicians and a large percentage of patients, both of whom are looking for a less invasive option to treat aortic stenosis."
This comes in the same week that the company's philanthropic Medtronic Foundation named the Illinois HeartRescue Collaborative and the American Medical Response as the newest partners on its HeartRescue Project.
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