Medical technology company Stryker has secured pre-market approval from the US Food and Drug Administration (FDA) for the use of its Surpass Streamline Flow Diverter in treating unruptured large and giant wide-neck intracranial aneurysms.
The flow diverter has been designed as a small cobalt chromium braided stent for directing blood flow inside an intracranial artery, away from a weakened blood vessel sac or aneurysm.
This blood flow diversion is meant to occlude the aneurysm over time, thereby decreasing the risk of rupture in the future.
Surpass Streamline, which is already marketed in other international countries, is the second such device to obtain the US regulatory approval.
Stryker Neurovascular division president Mark Paul said: “The PMA approval of Surpass Streamline Flow Diverter in the US is an important milestone for the division.
“It expands our commercial footprint into the flow diversion market and reinforces our commitment to complete stroke care for patients suffering from cerebrovascular disease.”
The treatment of unruptured aneurysms is considered more challenging due to their location and surrounding anatomy.
Stryker’s flow-diverting stent is said to be equipped to address these aneurysms in the neck region by reliably opening and delivering consistent mesh density for the occlusion and maintenance of perforator artery patency.
The FDA approval is based on clinical outcomes obtained during the prospective, multi-centre SCENT investigational device exemption (IDE) clinical trial.
According to the results, the trial met both primary and secondary endpoints, as well as demonstrated single stent efficacy with the Surpass Streamline Flow Diverter.
SCENT IDE trial co-principal investigator Ricardo Hanel said: “The ability to resheath, reposition and recapture the device without losing distal wire position is a significant advantage for Surpass.”