FREMONT, Calif., Nov. 19, 2015 /PRNewswire/ -- Cordis Corp. today announced the presentation of four-year data from its INNOVATION Trial at the 2015 VEITHsymposium® in New York City. Data from the study continues to demonstrate the INCRAFT® AAA Stent Graft System (INCRAFT® System) performs well in patients suffering from abdominal aortic aneurysms (AAA) four years after treatment.
The INNOVATION Trial is a multicenter, open-label, prospective study designed to assess the safety and performance of the device in the treatment of patients with AAA with investigational sites in Germany and Italy. Study Investigator Prof. Giovanni Torsello, MD, of the Department of Vascular Surgery, St. Franziskus Hospital and University Clinic of Munster presented the four-year results of the INNOVATION study at the VEITHsymposium®. The study results showed that after four years, the INCRAFT® System performed well with greater than 97 percent freedom from endoleaks and no stent graft migrations.1
"With the four-year study results demonstrating continued performance with the INCRAFT® System in Europe, Cordis' device is clinically established in a class of next-generation AAA devices," said Prof. Torsello. "In clinical practice, the INCRAFT® System is easy to use and has one of the lowest profiles of any endograft on the market. I strongly believe that the INCRAFT® System will continue to be a valuable option for physicians who remain eager for new technologies to enhance their ability to effectively treat patients with AAA."
The INCRAFT® System is intended for the endovascular treatment of patients with infrarenal AAA and features innovative technologies designed for durability, conformability, placement accuracy and sealing without the need for polymers. The INCRAFT® System is an ultra-low profile EVAR system with a 14 French (F) outer diameter, including the integrated sheath, which is equivalent to a 12F catheter sheath introducer profile.* Most EVAR stent grafts have a system profile ranging from 16F to 22F in size.
"We spent nearly a decade working with a talented team of interdisciplinary cardiovascular physicians to perfect the design of the INCRAFT® System and ensure the device would enable greater access to a life-saving therapy for AAA patients," said David Wilson, president, Cordis Corp., a Cardinal Health company. "Today, the INCRAFT® System is being used by doctors in regions around the world and the safety, durability and performance of the device is supported by a growing body of evidence as seen with the four-year INNOVATION study data."
The INCRAFT® System is approved for use and available for sale in Europe, Canada, Mexico, Colombia and Brazil. The INCRAFT® System is for investigational device use only in the U.S. and Japan, having been studied in the INSPIRATION Trial, which completed enrollment in 2013.
About AAA and Endovascular Aortic Repair (EVAR)
An estimated 24 million people worldwide suffer from AAA, an abnormal enlargement of the large blood vessel (aorta) that supplies blood to the abdomen, pelvis and legs. Most patients with AAA do not experience any noticeable symptoms, which is why AAA is commonly referred to as the "silent killer." While the cause is not well-known, an aneurysm may develop in the lower part of the aorta and cause it to weaken as it enlarges or bulges. As the aorta is the largest blood vessel in the body and main supplier of blood to the body, a damaged or ruptured AAA can cause life-threatening bleeding. EVAR is a minimally invasive alternative to open surgery for the repair of an AAA. The procedure involves the placement of a stent graft into the aneurysm through a small incision in the groin to prevent the aneurysm from rupturing.
Now in its fourth decade, VEITHsymposium® provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The five-day event features over 900 rapid-fire presentations from world-renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques. To register to attend the VEITHsymposium®, please visit www.VEITHpress.org or contact Pauline T. Mayer at 631.979.3780.
About Cordis Corporation
Cordis Corporation, a Cardinal Health company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with experts worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.
*16F outer diameter for the 34mm aortic bifurcate
1Cordis data on file
SOURCE Cardinal Health