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ROADSTER 30-Day Data Published for Silk Road Medical's Enroute Transcarotid NPS

November 11, 2015—The 30-day safety and efficacy results from the pivotal ROADSTER trial, which were presented last year during a Late-Breaking Clinical Trials Session at the Vascular Interventional Advances (VIVA) meeting held on November 4–7, 2014, in Las Vegas, Nevada, were published by Christopher J. Kwolek, MD, et al in the Journal of Vascular Surgery (2015;62:1227–1234).

Endologix AFX2 Anatomically Fixated Endograft Compared to Proximally Fixated Endografts in LEOPARD at 5 Years

November 4, 2022—Five-year results of the LEOPARD trial demonstrated that the AFX2 anatomically fixated endograft (Endologix LLC) has similar outcomes to commercially available proximally fixated endografts in endovascular aneurysm repair (EVAR) procedures.

Endologix 5-Year Real-World LEOPARD Trial Data of AFX Endograft Published

April 27, 2023—Endologix LLC announced the online publication of final 5-year results of the LEOPARD randomized controlled trial comparing outcomes of endovascular aneurysm repair using the Endologix AFX endograft system with anatomical fixation versus commercially available endografts with proximal fixation in a real-world population.

LEOPARD to Compare Endologix AFX System to Other Commercially Available EVAR Devices

September 29, 2014—Endologix, Inc. announced that it will conduct a prospective, randomized clinical trial to compare outcomes in endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs). The company says the LEOPARD trial (Looking at EVAR Outcomes by Primary Analysis of Randomized Data) has been designed to provide an unbiased assessment of commercially available EVAR devices.

FDA Clears Silk Road Medical's Next-Generation Enroute Transcarotid Neuroprotection System

April 13, 2016—Silk Road Medical, Inc. announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s next-generation Enroute transcarotid neuroprotection system (NPS), which is specifically designed and indicated for transcarotid artery revascularization (TCAR). On March 16, the company announced European CE Mark approval for the next-generation Enroute transcarotid NPS.

CE Mark Approved for Silk Road's Next-Generation Enroute Transcarotid NPS

March 15, 2016—Silk Road Medical, Inc. announced European CE Mark approval for its next-generation Enroute transcarotid neuroprotection system (NPS), which is designed and indicated for transcarotid artery revascularization (TCAR).