Covidien starts enrolling for neurovascular device trials

Covidien has started enrolling patients to participate in two new clinical trials that it hopes will demonstrate the efficacy of its advanced neurovascular solutions.

The smaller of the two studies, called PREMIER, will enroll up to 141 patients – the first of whom is already undergoing treatment at the Baptist Medical Center in Jacksonville, Florida – across 20 sites globally.

It will evaluate the Pipeline embolization device, which Covidien seeks to introduce as a potential treatment option for smaller unruptured intracranial aneurysms.

Secondly, the Dublin-based company will be enrolling as many as 1,000 patients across 60 US sites to participate in the STRATIS registry – a prospective, multi-centre, non-randomised, observational trial that will evaluate the use of its endovascular stroke devices in patients diagnosed with acute ischemic stroke.

"Covidien continues to design outcomes-based clinical studies to confirm the real world safety and effectiveness of its advanced neurovascular technologies," said Stacey Pugh, vice-president of the company's Medical Affairs and Neurovascular divisions.

Almost six million people worldwide die from stroke each year, according to data from the World Stroke Organization.