Pipeline Shield Device Shows Safety and Effectiveness in Treating Intracranial Aneurysms

Introduction The Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) (“Pipeline™ Shield PAS”) is a post‐approval study required by the FDA. The study collects safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA). This is the first U.S. study on the Pipeline™ Shield Device after its commercial approval in the U.S. Outcomes for patients at 6 Months (6M) and 1 Year (1Y), safety data through 3 Years (3Y) are reported below based on available follow‐up. Methods Patients with IAs in the internal carotid artery (ICA), and who are not contraindicated for the device or procedure per U.S. label, were enrolled in the Pipeline™ Shield PAS and will be followed for a minimum of 3 years. In the Pipeline™ Shield PAS, site data are monitored, safety data are assessed by an independent clinical events committee, and angiographic data are assessed by an independent core laboratory. The primary effectiveness endpoint is complete occlusion of the target aneurysm without significant parent artery stenosis (≤ 50%), and no retreatment of the target aneurysm. Results From December 2021 to December 2024, a total of 246 patients were enrolled at 16 sites and 237 patients underwent the index procedure, comprising the intent‐to‐treat (ITT) population. All patients in whom treatment was attempted received a device implant. Of the target aneurysms, 94.5% (224/237) were previously not treated and 96.2% (228/237) were never ruptured. Per Core Lab assessment at baseline, the 3 most frequent aneurysm locations were ICA segments C6, C7 and C4 with 60.4% (142/235), 17.9% (42/235) and 11.9% (28/235) of aneurysms, respectively. Imaging data for 177 patients at 6M and 104 patients at 1Y follow‐up were available. Per the independent Core Lab, complete aneurysm occlusion was reported in 73.9% (130/176) and 84.6% (88/104) of patients at 6M and 1Y follow‐up, respectively. Based on available data at follow‐up, mRS ≤2 was reported in 98.1% (154/157) and 98.3% (114/116) of patients at 6M and 1Y, respectively. There was low incidence of significant (>50%) parent artery stenosis (6M, 1.7% (3/177); 1Y (1.0% (1/104)) and retreatment (6M, 1.7% (3/177); 1Y (2.9% (3/104)). Based on available follow‐up through 3Y, strokes (all non‐disabling) were reported in 2.5% (6/237) of patients. Intra‐cranial hemorrhages (ICH) were reported in 1.3% (3/237) of patients, with no delayed ICH (>30 days post procedure). There was 1 reported neurological death and 1 reported non‐neurological death. Conclusions The Pipeline™ Shield PAS provides strong evidence that the Pipeline™ Shield Device is a safe and effective treatment option for ICA aneurysms.