News | April 09, 2010

Trial Explores Smaller Stent Grafts for Abdominal Aortic Aneurisms

April 9, 2010 – The first patients have been enrolled in the INNOVATION trial, which will assess the safety of a new stent graft system to treat abdominal aortic aneurisms (AAA).

Current AAA stent-grafts limit the range of patients suitable for endovascular aneurism repair (EVAR). Delivery and accurate placement can also be challenging. The new Incraft stent graft is supposed to be easier to implant due to its smaller size. Currently available EVAR devices have a system profile ranging from 18 to 24 French. Incraft’s delivery system profile is 13 French.

The INNOVATION trial (multicenter, open-label, prospective, non-randomized study of the Cordis AAA stent graft system in subjects with abdominal aortic aneurysm) will enroll up to 25 patients at three sites throughout Germany.

“The ability to customize the Incraft system during the procedure is a very helpful feature for clinicians,” said professor Giovanni Torsello, chief of vascular surgery at St. Franziskus Hospital in Muenster.

The initial procedures using the device were performed by professor Dierk Scheinert, head of the department of medicine, angiology and cardiology at Park-Krankenhaus Hospital in Leipzig, who is serving as principal investigator of the INNOVATION trial. “We have been excluding a significant portion of our AAA patients, especially women, from EVAR because current stent grafts have large and bulky delivery systems, making device introduction impossible for small or diseased access vessels,” he said. “The ultra-low profile delivery system of Incraft will make EVAR a possible treatment alternative for a wider range of patients.”

“I believe the Incraft stent graft system has the potential to impact how we treat AAA patients globally.” said Takao Ohki, M.D., chairman of the department of surgery at Jikei University School of Medicine in Tokyo, who has one of the largest AAA practices in the world.

The trial is sponsored by Cordis and both investigators and sites are under contract with Cordis to perform this research. The Physician Advisory Panel members are compensated for their time by Cordis.
An estimated 27 million people worldwide have abdominal aortic aneurysms. Left untreated, all aneurysms will eventually rupture, and more than 80 percent of aneurisms that rupture result in death. In the U.S. alone, about 15,000 people die every year due to an AAA rupture.

For more information:

Related Content

Endologix Reports Positive One-Year Results From the Ovation LUCY Study
News | Stent Grafts | July 16, 2018
Endologix Inc. announced one-year results from the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for...
FDA Committee Votes in Favor of Incraft AAA Stent Graft System
News | Stent Grafts | June 13, 2018
Cardinal Health announced that its Incraft Abdominal Aortic Aneurysm (AAA) Stent Graft System has received a favorable...
First Patient Enrolled in Gore Excluder Investigational Study
News | Stent Grafts | January 08, 2018
January 8, 2018 — W. L. Gore & Associates Inc.
FDA Concerned About Increase in stent graft Endovascular Type III Leaks
News | Stent Grafts | October 09, 2017
October 9, 2017 — The U.S.
Gore Announces First-in-Human Use of Gore TAG Conformable Thoracic Stent Graft
News | Stent Grafts | July 17, 2017
W. L. Gore & Associates Inc. announced the first patient implant of the Gore TAG Conformable Thoracic Stent Graft...
News | Stent Grafts | April 06, 2017
Endologix Inc. announced that the first patients were treated in the Expanding Patient Applicability with Polymer...
Gore, Viabahn VBX Balloon Expandable Endoprosthesis, stent graft, iliac artery, FDA approval
Technology | Stent Grafts | January 31, 2017
W. L. Gore & Associates (Gore) announced that the Gore Viabahn VBX Balloon Expandable Endoprosthesis (VBX Stent...
Lombard Medical, Aorfix endovascular stent graft, Japanese regulatory approval, IntellFlex LP Delivery System
News | Stent Grafts | January 11, 2017
January 11, 2017 — Lombard Medical Inc.
stent grafts, fluid flow model, clotting risk, Journal of Vascular Surgery

An anterior view is shown of the geometries of each of the graft configurations: (A) fenestrated, (B) antegrade branched, (C) retrograde branched, and (D) manifold stent graft. Image courtesy of Taylor Suess, et al.

News | Stent Grafts | January 05, 2017
January 5, 2017 — Whether patients with mechanical heart valves and stents must take blood thinners depends on how ef
News | Stent Grafts | December 13, 2016
Lombard Medical Inc. announced that its Altura endovascular stent graft system was featured in a scientific...
Overlay Init