News | May 07, 2009

Medtronic Completes Early Enrollment in U.S. Study of Endurant Abdominal Aortic Stent Graft

May 7, 2009 - Medtronic Inc. yesterday said it completed enrollment in its investigational device exemption (IDE) study of the Endurant Stent Graft System, which is designed to enable the nonsurgical repair of aortic aneurysms.

Key data from this study, now expected in the second half of 2010, will be used to support the FDA pre-market approval (PMA) submission for U.S. approval of Endurant.

“The clinical community is excited by what this device offers to patients,” said the study’s principal investigator, Dr. Michel Makaroun of the University of Pittsburgh School of Medicine. “The device combines unique improvements with the best features from existing technology. Enthusiastic clinician interest is evident from Endurant’s rapid adoption in Europe, and now accelerated enrollment of the U.S. study.”

Designed to evaluate the safety and effectiveness of the Endurant Stent Graft System for the endovascular aortic repair (EVAR) of abdominal aneurysms, the U.S. Endurant IDE study was enrolled two months ahead of schedule, having started in 2008 and involving 30 sites.

For more information: www.medtronic.com

Related Content

Open Heart Surgery Outperforms Stents in Patients With Multivessel Disease
News | Cardiovascular Surgery | May 03, 2019
Coronary artery bypass grafting (CABG) surgery may be the best treatment option for most patients with more than one...
SherpaPak Cardiac Transport System Cleared for Pediatric and Small Donor Hearts
Technology | Cardiovascular Surgery | February 01, 2019
Paragonix Technologies Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) for a design...
Transplanting Pig Hearts Into Humans One Step Closer. A pig heart, shown here, is very similar in size and anatomy to a human heart. For this reason, pigs are used extensively in pre-clinical animal testing for new implantable cardiovascular devices. If pig hearts could be used for human transplantation, it would greatly alleviate shortages of donor human hearts.

A pig heart, shown here, is very similar in size and anatomy to a human heart. For this reason, pigs are used extensively in pre-clinical animal testing for new implantable cardiovascular devices. If pig hearts could be used for human transplantation, it would greatly alleviate shortages of donor human hearts.

News | Cardiovascular Surgery | December 11, 2018
The scientific journal Nature recently published an article from Munich University Hospital which describes the long-...
Bilateral Artery Use Does Not Improve 10-Year CABG Outcomes
News | Cardiovascular Surgery | September 06, 2018
While it is firmly established that the use of one internal thoracic artery can improve life expectancy in coronary...
Mandatory Public Coronary Artery Bypass Grafting Reporting Associated With Better Patient Outcomes
News | Cardiovascular Surgery | April 30, 2018
Mandatory public reporting of coronary artery bypass grafting (CABG) results in Massachusetts was associated with...
Gecko Biomedical Receives CE Mark Approval for Setalum Sealant
News | Cardiovascular Surgery | September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery | September 08, 2017
September 8, 2017 — ClearFlow Inc.
Videos | Cardiovascular Surgery | July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Intensive Glycemic Control Program Produces Significant Per-Patient Cost Savings for CABG Surgery
News | Cardiovascular Surgery | May 25, 2017
A new study from Emory University observed a near-20 percent reduction in perioperative complications, a 1.2-day...
Overlay Init