Medical technology Stryker has secured pre-market approval from the US Food and Drug Administration’s (FDA) for its Surpass Streamline Flow Diverter to treat unruptured and large neck intracranial aneurysms.
The Surpass Streamline device is the second flow diverting stent to secure FDA approval in the U.S. It is also approved and available in several markets globally.
The Surpass Streamline flow diverter is a small cobalt chromium braided stent, used for directing blood flow within an intracranial artery away from a weakened blood vessel sac or aneurysm.
The diversion of blood flow obstructs the aneurysm over time reducing the risk of further rupture in the future.
It is estimated that 6 million people in the US have an unruptured brain aneurysm, out of which about 25,000 are treated with endovascular or surgical treatments each year, according to Brain Aneurysm Foundation Statistics.
Surpass Streamline is claimed to be the first flow diverter indicated for large and giant posterior communicating artery aneurysms.
The stent is designed to open and offer consistent mesh density across the neck of the aneurysm to support in aneurysm occlusion and maintain perforator artery patency.
Baptist Health System, Baptist Neurological Institute director and the SCENT IDE Co-Principal Investigator Ricardo Hanel stated that SCENT is one of the largest, prospective, multicenter clinical trials on flow diversion that is generalizable to real world outcomes.
Surpass Streamline Flow Diverter was the first flow diverter IDE study to show the efficacy of the single stent in successfully meeting the primary and secondary endpoints. One significant advantage of Surpass is that it has the ability to resheath, reposition and recapture the device without losing distal wire position.
Stryker Neurovascular division president Mark Paul said: “The PMA approval of Surpass Streamline Flow Diverter in the U.S. 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.”
Stryker provides products and services in orthopaedics, medical and surgical, and neurotechnology and Spine that help enhance patient and hospital outcomes.