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July 15, 2018

FDA Approves Stryker's Surpass Streamline Flow Diverter to Treat Intracranial Aneurysms

July 16, 2018—Stryker announced that the FDA has granted premarket approval for the Surpass Streamline flow diverter to treat unruptured large and giant wide-neck intracranial aneurysms. 

Stryker's Surpass Streamline flow diverter is a small, cobalt-chromium-braided stent used to direct blood flow away from a weakened intracranial blood vessel sac or aneurysm.

The approval of the device was supported by the clinical outcomes in the SCENT investigational device exemption (IDE) trial. The trial was led by Co-Principal Investigators Philip Meyers, MD, and Ricardo Hanel, MD. Dr. Meyers is Professor of Radiology and Neurological Surgery at New York Presbyterian/Columbia University Medical Center in New York, New York. Dr. Hanel is from the Baptist Neurological Institute at the Baptist Health System in Jacksonville, Florida.

In the company's announcement, Dr. Meyers commented, "Surpass Streamline is the first flow diverter indicated for large and giant posterior communicating artery aneurysms. These unruptured aneurysms are more challenging due to their location and surrounding anatomy. Having Surpass approved for this and other locations is an important advantage for physicians and patients. The stent is designed to reliably open and provide consistent mesh density across the neck of the aneurysm to aid in aneurysm occlusion while maintaining perforator artery patency."

Dr. Hanel added, "SCENT is one of the largest, prospective, multicenter clinical trials on flow diversion that is generalizable to real-world outcomes. This was the first flow diverter IDE study to show single-stent efficacy while successfully meeting the primary and secondary endpoints. The ability to resheath, reposition, and recapture the device without losing distal wire position is a significant advantage for Surpass."

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July 16, 2018

CSI Signs International Distribution Agreement With OrbusNeich

July 16, 2018

CSI Signs International Distribution Agreement With OrbusNeich