FREMONT, Calif. -- (BUSINESS WIRE) --
Cordis Corporation announced today the launch of its INCRAFT® AAA Stent Graft System (INCRAFT® System), an ultra-low profile device for use during endovascular aneurysm repair (EVAR) for patients suffering from infrarenal abdominal aortic aneurysms (AAA). The INCRAFT® System is cleared for use and now available in Europe and Canada. This device is an advancement in the EVAR field and provides a new option for patients and physicians seeking a less invasive treatment approach for AAA.
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. Left untreated, all aneurysms will eventually rupture and the majority of ruptured aneurysms result in death.
The INCRAFT® System is intended for the endovascular treatment of patients with infrarenal AAA. The INCRAFT® System, which features an ultra-low profile endovascular stent graft system with innovative technology designed for durability, conformability and sealing without the need for polymers, is intended to reinforce the lower part of the aorta to prevent an aneurysm from rupturing. The INCRAFT® System is the lowest profile EVAR system now available in Europe and Canada 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.
This ultra-low profile device is designed for proximal and distal placement accuracy and allows for customization during the procedure to accommodate a wide range of anatomical sizes. This broad anatomical coverage is offered with a minimal number of product codes for easier pre-procedural planning.
“The INCRAFT® System is an attractive new EVAR device option because its ultra-low profile design and customization allows physicians to consider this less invasive procedure for many patients, especially those with smaller vasculature who might otherwise be ineligible for EVAR,” said Prof. Giovanni Torsello, MD, of the St. Franziskus Hospital Münster in Germany. “The recently published two-year data on the INCRAFT® System from the INNOVATION Trial in Europe demonstrated excellent performance adding to the scientific data supporting the device.”
The INNOVATION Trial is a multicenter, open-label, prospective, non-randomized 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. At two years, results from the study demonstrated the device performed well in patients and showed no incidences of aneurysm enlargement, endoleaks (type I, or III), device or procedure related major adverse events, stent-graft migrations or stent fractures. One patient in the study developed a late graft occlusion unrelated to the device that was caused by shrinkage of the aneurysm. The two-year study results were presented at the 2014 Charing Cross Symposium and subsequently published in the July 2014 online issue of the Journal of Vascular Surgery.1
“With the launch of the INCRAFT® System, Cordis is bringing an innovative advancement to the field of EVAR, while entering a growth segment that further diversifies our strong product portfolio,” said Celine Martin, Worldwide President, Cordis Corporation. “At Cordis, we are proud to deliver market-relevant interventional vascular treatments to address unmet needs, and with the availability of the INCRAFT® System, more patients will have access to an important, new EVAR treatment option.”
The INCRAFT® System is currently approved for investigational device use only in the U.S. and Japan and is being studied in a global pivotal clinical study in the U.S. and Japan called the INSPIRATION Trial, which completed enrollment in 2013.
About Abdominal Aortic Aneurysms (AAA) and Endovascular Aortic Repair
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. Most patients with AAA do not experience any noticeable symptoms and is why AAA is commonly referred to as the “silent killer.” 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.
About Cordis Corporation
Cordis Corporation, part of the Johnson & Johnson Family of Companies, 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 can be found at www.cordis.com or in product labeling.
1J Vasc Surg. 2014 Jul 19. pii: S0741-5214(14)01118-5. doi: 10.1016/j.jvs.2014.06.007. [Epub ahead of print]
*16F outer diameter for the 34 mm aortic bifurcate.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, including expectations related to the INCRAFT® AAA Stent Graft System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Cordis Corporation and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: manufacturing difficulties and delays, internally or within the supply chain; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; and general industry conditions, including trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Cordis Corporation nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments).
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INCRAFT(R) AAA Stent Graft System (Graphic: Business Wire)