Artivion Granted FDA Humanitarian Device Exemption for AMDS Hybrid Prosthesis

December 9, 2024—Artivion, Inc. announced that the FDA has granted a humanitarian device exemption (HDE) for the use of the AMDS hybrid prosthesis (formerly known as the Ascyrus Medical dissection stent), an aortic arch remodeling device for in acute DeBakey type I dissections in the presence of malperfusion.

Centerline Biomedical’s IOPS Guidewire Handle Receives FDA Clearance

December 4, 2024—Centerline Biomedical, Inc. announced that the company received FDA 510(k) clearance for its IOPS intra-operative positioning system guidewire handle.

SVS Launches Highway to Health Public Awareness Campaign

October 23, 2024—The Society for Vascular Surgery (SVS) announced the launch of its Highway to Health campaign aims to educate and raise awareness about the symptoms and risk factors associated with vascular disease.

Endospan’s Nexus TRIOMPHE IDE Study Completes Enrollment of Primary Arm

October 21, 2024—Endospan announced the completion of enrollment for the primary arm of its TRIOMPHE investigational device exemption (IDE) clinical study for the company’s bimodular Nexus aortic arch stent graft.

Cook Medical Creates Custom-Made Fenestrated Graft for FET Aortic Procedure

September 30, 2024—Cook Medical announced that it created a custom-made device for the frozen elephant trunk (FET) aortic procedure.

Centerline’s IOPS Viewpoint Catheter Receives FDA Clearance

August 6, 2024—Centerline Biomedical, Inc. announced the expansion of its intraoperative positioning system (IOPS) portfolio with FDA 510(k) clearance of the IOPS Viewpoint catheter.

Endospan Receives Additional Funding From Artivion

July 2, 2024—Endospan Ltd., an Israel-based developer of the Nexus stent graft system, announced an agreement with Artivion, Inc. for additional loans of up to $25 million.

Gore’s TAG Thoracic Branch Endoprosthesis Approved and Launched in Canada

June 27, 2024—Gore & Associates announced the Health Canada regulatory approval and the first commercial use in Canada of the company’s TAG thoracic branch endoprosthesis (TBE).

GE HealthCare and MediView Launch OmnifyXR Augmented Reality Interventional Suite

June 20, 2024—GE HealthCare and MediView XR Inc. announced the first installation of the OmnifyXR interventional suite.

Medtronic’s Steerant Aortic Guidewire Is Launched for EVAR and TEVAR Procedures

June 17, 2024—Medtronic announced the launch of the Steerant aortic guidewire.

Gore TAG Thoracic Branch Endoprosthesis Introduced in Europe

February 1, 2024—Gore & Associates announced the first implantation of the Gore TAG thoracic branch endoprosthesis (TBE) in Europe.

Gore’s Viabahn VBX Stent Graft With Lower Profile Gains FDA Approval

January 31, 2024—Gore & Associates, Inc. announced that the FDA approved a lower profile Viabahn VBX balloon expandable endoprosthesis for treating complex vascular disease.

Endospan’s Nexus Aortic Arch Endovascular System Evaluated in Early TRIOMPHE IDE Study Results

January 30, 2024—Endospan, an Israel-based company focused on off-the-shelf endovascular repair of aortic arch disease, announced the presentation of 30-day results of the first 22 patients enrolled in the TRIOMPHE investigational device exemption (IDE) study.

Gore’s Excluder TAMBE Approved by FDA to Treat Complex Aortic Aneurysms

January 25, 2024—Gore & Associates announced FDA approval for the Excluder thoracoabdominal branch endoprosthesis (TAMBE).

Gore Ascending Stent Graft’s ARISE II Pivotal Study Enrolls First Patient

December 20, 2023—Gore & Associates announced the commencement of the ARISE II pivotal trial.