Stent for Unruptured Aneurysm Receives FDA Pre-Market Approval

The US Food and Drug Administration (FDA) has granted pre-market approval (PMA) to the Stryker Corporation for the Surpass Streamline Flow Diverter to treat unruptured large and giant wide-neck intracranial aneurysms. It is approved for use in the internal carotid artery up to the terminus.

"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," said Philip Meyers, MD, Professor of Radiology and Neurological Surgery at New York Presbyterian/Columbia University Medical Center and Co-Principal Investigator for the SCENT Investigational Device Exemption (IDE) trial which provided clinical outcomes to support Surpass PMA approval. “Having Surpass approved for this and other locations is an important advantage for physicians and patients.”

The Surpass Streamline is a cobalt chromium braided stent is the second flow diverting stent to receive FDA approval for use in the United States.

"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," said Meyers.

The SCENT trial has completed the intervention stage but data on outcome measures and adverse events is expected to be collected until December 2020. The study included 180 patients, ages 18 to 80 years of age, with a single intracranial aneurysm.

"SCENT is one of the largest, prospective, multicenter clinical trials on flow diversion that is generalizable to real world outcomes,” added Ricardo Hanel, MD, PhD, Director of the Baptist Neurological Institute at the Baptist Health System in Jacksonville, Florida and Co-Principal Investigator for the SCENT IDE trial. “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."