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Pre-market approval by FDA given to Stryker's flow diverter

Stryker is a medical technology company which has obtained pre-marketing approval from USFDA for the use of its Surpass Streamline Flow Diverter in treating unruptured large and giant wide-neck intracranial aneurysms. Surpass Streamline is already marketed in other international countries and is the second such device to get USFDA approval.

The flow diverter is a small cobalt chromium braided stent which has been designed in a way to allow blood flow inside an intracranial artery away from a weakened blood vessel sac or aneurysm. This type of diversion leads to occlusion of the aneurysm over time thereby leading to decrease the risk of rupture in the future. Stryker’s flow-diverting stent is meant to address the aneurysms in the neck region by reliably opening and delivering consistent mesh density for the occlusion and maintenance of perforator artery patency as the treatment of unruptured aneurysms is more challenging due to their location and surrounding anatomy.

The approval has been given on the basis of results obtained in a prospective, multi-centre SCENT investigational device exemption (IDE) clinical trial according to which the trial met the required primary and secondary endpoints and also showed single stent efficacy with the Surpass Streamline Flow Diverter. According to the principal investigator of the trial," The ability to resheath, reposition and recapture the device without losing distal wire position is a significant advantage for Surpass."

According to Mark Paul (President of the Stryker Neurovascular Division)," The Surpass Streamline Flow Diverter approval in US is an important milestone for the company as it expands the commercial division into the flow diversion market and reinforces the company's commitment to complete stroke care for patients suffering from cerebrovascular disease."