First Patients Enrolled in Cordis Trial of New Stent Graft System to Treat Abdominal Aortic Aneurysm
By Cordis Corporation, PRNEThursday, April 8, 2010
Trial Will Explore a More Individualized Endovascular Approach Targeting a Broader Patient Population for a Life-Threatening Condition that Affects 27 Million People Worldwide
LONDON, April 9, 2010 - Cordis Corporation, a worldwide leader in the development and manufacture
of interventional vascular technologies, announced today that the first
patients have been enrolled in the INNOVATION trial, which will assess the
safety and performance of a new stent graft system, called INCRAFT(TM), to
treat abdominal aortic aneurysm (AAA). An estimated 27 million people
worldwide have abdominal aortic aneurysms. Left untreated, all aneurysms will
eventually rupture, and more than 80% of aneurysms that rupture result in
death.
"The need for improved AAA treatments is significant," said Campbell
Rogers, M.D., Chief Scientific Officer and Head, Global Research and
Development, Cordis Corporation. "Current AAA stent-grafts limit the range of
patients suitable for endovascular aneurysm repair (EVAR) and make delivery
and placement accuracy challenging and complex, which can compromise short
and long term safety of EVAR procedure. We are very excited about the
first-in-human use of our INCRAFT(TM) stent graft system, which we believe
has the potential to set a new standard in the field of EVAR."
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 in 3 sites
throughout Germany. The trial investigators are Professor Jan Brunkwall,
Chairman of the Department of Vascular Surgery at Universitatkliniken,
Cologne, Professor Dierk Scheinert, head of the Department of Medicine,
Angiology and Cardiology at Park-Krankenhaus Hospital in Leipzig and
Professor Giovanni Torsello, Chief of Vascular Surgery at St. Franziskus
Hospital in Muenster.
Professor Torsello commented, "I am pleased to be a part of the
INNOVATION trial. The ability to customize the INCRAFT(TM) system during the
procedure is a very helpful feature for clinicians." "We look forward to
assessing the clinical benefits of this more individualized AAA therapy for
patients in this study," added Professor Brunkwall.
The initial procedures using INCRAFT(TM) were performed by Professor
Scheinert, who is serving as Principal Investigator of the INNOVATION trial.
According to Professor Scheinert, "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. The ultra-low
profile delivery system of INCRAFT(TM) will make EVAR a possible treatment
alternative for a wider range of patients."
Currently available EVAR devices have a system profile ranging from 18 to
24 French. INCRAFT's delivery system profile is 13 French.
Cordis has been developing INCRAFT(TM) with input from a
multidisciplinary Physician Advisory Panel that includes Takao Ohki, M.D.,
Chairman of the Department of Surgery at Jikei University School of Medicine
in Tokyo; Corey Teigen, M.D., Managing Physician Partner, MeritCare Vascular
Center, Fargo, ND; Robert Bersin, M.D., Medical Director, Endovascular
Services, Seattle Cardiology and Swedish Medical Center, WA.
"I believe the INCRAFT(TM) stent graft system has the potential to impact
how we treat AAA patients globally." said Dr. Ohki, who has one of the
largest AAA practices in the world.
The INNOVATION 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.
About Cordis Corporation
For more than 50 years, Cordis Corporation, a Johnson & Johnson company, has
been a worldwide leader in the development and manufacture of interventional
vascular technology. Through the company's innovation, research and
development, Cordis partners with interventional cardiologists worldwide to
treat millions of patients who suffer from vascular disease.
Media Contacts: PR Contact Isabella Sharp Telephone: +44(0)20-7526-3632 Or Ulrike Domany-Funtan Mobile: +43(664)83-504-83
Media Contacts: PR Contact Isabella Sharp, Telephone: +44(0)20-7526-3632, or Ulrike Domany-Funtan, Mobile: +43(664)83-504-83
Tags: April 9, Cordis Corporation, London, United Kingdom