Endospan’s Nexus Aortic Arch Stent Graft System Approved by FDA

April 7, 2026—Endospan, an Israel-based developer of solutions for the endovascular repair of aortic arch disease, announced that the FDA has approved the Nexus aortic arch stent graft.

Terumo Aortic’s Fenestrated Treo Abdominal Stent Graft System Granted FDA Breakthrough Device Designation

March 16, 2026—Terumo Aortic announced that the FDA has granted Breakthrough Device designation for the company’s fenestrated Treo abdominal stent graft system.

iVascular Begins FENCO Study of iCover Stent in FEVAR

February 24, 2026—iVascular announced the enrollment of the first patient in the FENCO clinical study evaluating the company’s iCover balloon-expandable polytetrafluoroethylene (ePTFE)–covered stent system in fenestrated endovascular aneurysm repair (FEVAR) for the treatment of complex abdominal aortic aneurysms.

Endospan’s Nexus Aortic Arch Stent Graft System Evaluated at 1 Year in TRIOMPHE Pivotal Study 

February 3, 2026—Endospan, a privately held, Israel-based company focused on the endovascular repair of aortic arch disease, announced 1-year results of the TRIOMPHE investigational device exemption study of its Nexus aortic arch stent graft system.

Major Medical Devices Appoints Eric Curtis as CEO

January 21, 2026—Major Medical Devices, Inc. (MMD), an emerging developer in vascular intervention technologies for abdominal aortic aneurysm (AAA), announced the appointment of Eric Curtis as its Chief Executive Officer (CEO).

Shape Memory Medical’s Impede Embolization Plug Product Family Secures EU MDR Certification

December 22, 2025—Shape Memory Medical Inc. announced that its Impede embolization plug product family, which previously received CE Mark approval under the European Union (EU) Medical Device Directive 93/42/EEC, has received certification as a class III device under the more stringent EU Medical Device Regulation (MDR) 2017/745.

Gore Excluder TAMBE Introduced in Japan

December 19, 2025—Gore & Associates G.K. in Minato-ku, Tokyo, Japan, announced the first clinical use in Japan of the Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE).

ARISE III Trial of Gore Ascending Stent Graft Begins Enrollment

December 15, 2025—Gore & Associates announced the first implantation of its investigational Gore Ascending Stent Graft in the ARISE III trial for the treatment of an acute type A dissection.

Bentley’s BeGraft Plus for BEVAR Used in First Clinical Procedure

December 3, 2025—Bentley InnoMed GmbH, which is headquartered in Hechingen, Germany, announced the first-in-human use of the company’s BeGraft Plus, which features a new 77/78-mm length.

PRINCIPIIS FIH Study Begins for Angiolutions A3 Shield System in Early Stage AAA

December 3, 2025—Angiolutions announced that the first patient has been treated in a first-in-human (FIH) study evaluating the safety and effectiveness of the company’s investigational A3 Shield system.

Rampart Guardian Radiation Protection System Evaluated in EVAR Procedure

December 3, 2025— Rampart IC, a developer of radiation shielding for interventional suites, announced new data on the reduction in radiation exposure achieved using the Rampart Guardian system, a lead-free, total-body, total-team protection solution.

Philips Expands Commercial Availability of LumiGuide Light-Based 3D Navigation Solution 

December 1, 2025—Royal Philips announced the expanded commercial availability of its LumiGuide device guidance across Europe and the United States.

Bentley’s BeGraft Plus for BEVAR Receives CE Mark Approval

November 19, 2025—Bentley InnoMed GmbH announced CE Mark approval for the company’s BeGraft Plus for use as a bridging stent graft in branched endovascular aneurysm repair (BEVAR), expanding Bentley’s portfolio for complex aortic interventions.

Terumo Aortic’s Fenestrated TREO Pivotal IDE Study Begins in the United States

November 19, 2025—Terumo Aortic announced enrollment of the first patient in the fenestrated TREO pivotal trial in the United States.

RapidAI’s Rapid Aortic Solution Cleared by FDA 

November 18, 2025—RapidAI announced FDA clearance of Aortic Management, part of the company’s Rapid Aortic product, a clinical artificial intelligence (AI) solution for acute assessment and longitudinal management of aortic disease.

ViTAA Medical’s AiORTA Plan Cleared by FDA

November 12, 2025—ViTAA Medical Solutions Inc. announced that the FDA has granted 510(k) clearance for the company’s AiORTA Plan.

Nurea PraevAorta 2 Software Cleared by FDA for Aortic Aneurysm Management 

October 22, 2025—Nurea announced that its PraevAorta 2 software has received FDA 510(k) clearance for the United States market.

Shape Memory Medical Marks 50% Enrollment in AAA-SHAPE Pivotal Trial

October 16, 2025—Shape Memory Medical Inc. announced that it has reached 50% enrollment in the ongoing AAA-SHAPE Pivotal Trial (NCT06029660) evaluating the IMPEDE-FX RapidFill device (Shape Memory Medical) for abdominal aortic aneurysm (AAA) sac management during endovascular aneurysm repair (EVAR), according to the company’s press release.

Medtronic’s Endurant Stent Graft System’s rAAA Labeling Updated by FDA

October 13, 2025—Medtronic announced that the FDA has approved new labeling for the company’s Endurant stent graft system for use in the treatment of ruptured abdominal aortic aneurysms (rAAA), removing the previous rAAA treatment warning.

Getinge’s Advanta V12 Covered Stent Approved in Europe for Bridging Indications

October 13, 2025—Getinge announced that its Advanta V12 covered stent system has received approval in Europe for use as a bridging stent in fenestrated endovascular aneurysm repair (FEVAR), branched endovascular aneurysm repair (BEVAR), and iliac branch device (IBD) aneurysmal repair.