Search Results

Terumo Aortic’s RelayBranch Thoracic Stent Graft System Granted FDA Breakthrough Device Designation

March 18, 2022—Terumo Aortic announced that the FDA has granted Breakthrough Device designation for the company’s RelayBranch thoracic stent graft system, which is part of a feasibility study currently enrolling in the United States.

Bolton Medical's Relay Plus System Used in US Trial

October 29, 2009—Bolton Medical (Sunrise, FL) announced the first use of the Relay Plus system in the company's United States Relay clinical trial.

Bolton Medical's Relay Plus Delivery System Used in Relay Stent Graft Trial

October 29, 2009—Bolton Medical (Sunrise, FL) announced the first use of the Relay Plus system in the company's United States Relay clinical trial.

Bolton Medical Begins Phase 2 Trial for RelayPro to Treat Descending TAA

May 16, 2017—Bolton Medical announced that the first patient has been enrolled in the RelayPro US Food and Drug Administration (FDA) phase 2 clinical trial, which is designed to study the safety and effectiveness of the company's RelayPro thoracic stent graft system as a treatment for endovascular repair of descending thoracic aortic aneurysms (TAA).

Terumo Aortic Completes Enrollment of RelayPro United States Pivotal Trial

September 26, 2019—Terumo Aortic announced the completion of enrollment of the RelayPro pivotal trial in the United States.

PERSEVERE Trial of Artivion’s AMDS Hybrid Prosthesis Completes Enrollment

November 9, 2023—Artivion, Inc. announced that it has completed enrollment in the PERSEVERE clinical trial of the AMDS hybrid prosthesis (formerly known as the Ascyrus Medical dissection stent).

Artivion Initiates PERSEVERE Clinical Trial of AMDS Hybrid Perfusion Device

July 27, 2022—Artivion, Inc., a cardiac and vascular surgery company focused on aortic disease, announced that it has initiated enrollment in the PERSEVERE clinical trial to determine if patients with an acute DeBakey type I aortic dissection can be treated safely and effectively using the AMDS hybrid prosthesis (formerly known as the Ascyrus Medical dissection stent).

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.

Terumo Aortic’s RelayPro Thoracic Stent Graft System Introduced Commercially in United States

September 16, 2021—Terumo Aortic announced the first commercial implants in the United States of its RelayPro thoracic stent graft system, which was recently approved by the FDA for treatment of patients with fusiform and saccular aneurysms and penetrating atherosclerotic ulcers in the descending thoracic aorta.

FDA Approves Terumo Aortic’s RelayPro Thoracic Stent Graft

August 6, 2021—Terumo Aortic announced it has received FDA approval of RelayPro, the company’s low-profile, next-generation thoracic stent graft device designed for use in thoracic endovascular aortic repair for patients with small access vessels.