News | Stent Grafts | August 13, 2015

Medtronic Completes First European Cases With Endurant Evo AAA Stent Graft System

Investigational medical device poised to expand applicability of minimally invasive alternative to open surgical repair

Medtronic, Endurant Evo AAA, stent graft system, first European cases

August 13, 2015 — Medtronic plc announced that the first two European patient cases with the Endurant Evo AAA stent graft system were successfully performed at the Erasmus Medical Center in Rotterdam, Netherlands. Both procedures were performed by Prof. Hence Verhagen, M.D., Ph.D., chief of vascular surgery, and his team.

Medtronic began a clinical study in April 2015 to evaluate the safety and effectiveness of the Endurant Evo AAA stent graft system, an investigational medical device designed to expand the applicability of a minimally invasive alternative to open surgical repair for the treatment of abdominal aortic aneurysms.

The first patient was 70 years old and had a 52mm aneurysm. The implant was done with a percutaneous approach thanks to the device’s low profile. The case was successful, with no endoleaks at the final control. The second patient was 74 years old and had a 55mm aneurysm. All the devices were correctly positioned thanks to the 3-piece approach and in-situ sizing capabilities, after a planned coiling and overstenting of one hypogastric artery. The precise deployment resulted in procedural success with no endoleaks at the final imaging.

“The Endurant Evo AAA stent graft system has the potential to improve the treatment for abdominal aortic aneurysms. The system is well designed and the simplified procedure helped to reduce the procedure time,” said Verhagen.

The study will enroll 140 patients with infrarenal abdominal aortic or aortoiliac aneurysms at up to 30 sites in Europe and the United States. All study patients will be treated with the Endurant Evo AAA stent graft system. The study will evaluate safety and efficacy of the new stent graft system. The primary effectiveness objective is to evaluate successful delivery and deployment of the Endurant Evo AAA stent graft system with successful removal of the delivery system during the index procedure. Safety endpoint is defined as the proportion of subjects free from a major adverse event within 30 days post-implantation;

Clinical evidence from the study will be used to seek regulatory approvals required to commercialize the Endurant Evo AAA stent graft system in European, U.S. and other markets around the world.

For more information: www.medtronic.com

Related Content

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
News | Cardiac Diagnostics| September 12, 2017
Contracting shingles, a reactivation of the chickenpox virus, increases a person’s risk of stroke and heart attack,...
Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study in Denmark

Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study. Photo credit: Lisbeth Hasager Justesen, Viborg Hospital.

News | Cardiac Diagnostics| September 12, 2017
September 12, 2017 — A new screening program for vascular disease saves one life for every 169 men assessed, accordin
Overlay Init