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

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...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery | May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
Scientists Show How Cells React to Injury From Open-Heart Surgery
News | Cardiovascular Surgery | May 04, 2017
Cedars-Sinai Heart Institute investigators have learned how cardiac muscle cells react to a certain type of injury that...
ERACS Session Highlights Need for Standardized Best Practices in Cardiac Surgery
News | Cardiovascular Surgery | May 02, 2017
The recently formed group Enhanced Recovery After Cardiac Surgery (ERACS) hosted an organizing session in Boston on...
ClearFlow Receives Frost & Sullivan New Product Innovation Award for PleuraFlow Technology
News | Cardiovascular Surgery | May 01, 2017
ClearFlow Inc. has received the prestigious 2017 Global Frost & Sullivan Award for New Product Innovation. The...
Edwards Intuity Elite sutureless aortic valve, first implants in Connecticut, WCHN, Western Connecticut Health Network
News | Cardiovascular Surgery | February 16, 2017
Western Connecticut Health Network (WCHN) cardiothoracic surgeons Cary Passik, M.D., and Robert Gallagher, M.D., were...
Overlay Init