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Conformable Gore TAG's FDA Approval Becomes First to Include Endovascular Repair of Aortic Dissection

September 11, 2013—Gore & Associates (Flagstaff, AZ) has announced that the US Food and Drug Administration (FDA) approval for the company's Conformable Gore TAG thoracic endoprosthesis now includes endovascular repair of acute and chronic type B dissections of the descending thoracic aorta.

Silk Road Medical Submits PMA Application for Enroute Systems, Supported by ROADSTER Data

November 24, 2014—Silk Road Medical, Inc. has submitted a premarket approval (PMA) application to the US Food and Drug Administration seeking 510(k) clearance for the Enroute transcarotid neuroprotection system (NPS) and stent system platform.

Enrollment Completed in Pivotal ROADSTER Trial for Silk Road's Enroute CAS Device

July 16, 2014—Silk Road Medical, Inc. announced the completion of enrollment in the pivotal ROADSTER study of the company’s Enroute transcarotid neuroprotection system (NPS).

FDA Clears Silk Road Medical's Enroute Transcarotid Neuroprotection System

February 10, 2015—Silk Road Medical, Inc. announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance for its Enroute transcarotid neuroprotection system (NPS), which is used to directly access the common carotid artery and initiate high-rate temporary blood flow reversal to protect the brain from stroke while performing carotid angioplasty and stenting (CAS).

VIVA 2011: PROOF Feasibility Study of a Novel Transcervical Neuroprotection System in Carotid Revascularization

October 19, 2011—First-in-man results from the PROOF study of a novel transcervical neuroprotection device for use during hybrid carotid artery stenting were presented by Sumaira Macdonald, MD, PhD, at the VIVA 2011: Vascular Interventional Advances meeting in Las Vegas, Nevada.

TEVAR Studied for Acute Catastrophes of the Descending Thoracic Aorta

December 3, 2009—In the Journal of Vascular Surgery, Richard P. Cambria, MD, et al published findings from a multicenter clinical trial of endovascular stent graft repair of acute catastrophes of the descending thoracic aorta (2009;50:1255-1264).

LITERATURE HIGHLIGHTS: Study Supports TEVAR for Acute Catastrophe Cases

December 3, 2009—In the Journal of Vascular Surgery, Richard P. Cambria, MD, et al published findings from a multicenter clinical trial of endovascular stent graft repair of acute catastrophes of the descending thoracic aorta (2009;50:1255–1264).

Findings Published for Gore Conformable Stent Graft to Treat Acute Complicated Type B Dissection

August 11, 2015—In the Journal of Vascular Surgery, Richard P. Cambria, MD, et al published the results of a multicenter clinical trial of a conformable stent graft for the treatment of acute complicated type B dissection (2015;62:271–278). 

Study Suggests TEVAR May Benefit Some Patients With Uncomplicated Acute Type B Aortic Dissection

November 29, 2016—Findings from a single-center, retrospective study that sought to determine the predictors of intervention and mortality in patients with uncomplicated acute type B aortic dissection (uATBAD) were published by Hunter M. Ray, MD, et al in the Journal of Vascular Surgery (JVS; 2016;64:1560–1568).