Bjaeverskov, Denmark, April 1, 2009 – Patients undergoing endovascular repair of thoracic aneurysms can now receive the clinical benefits of Cook Medical's new Zenith® TX2® TAA Endovascular Graft with Pro-Form™ for more controlled treatment of thoracic aortic aneurysms (TAAs). Cook's new TX2 Pro-Form endograft, which has received CE Mark approval, utilizes an improved delivery system that allows for carefully controlled deployment of the endograft to help ensure proximal conformity of the device to the aortic wall. This innovation offers patients unparalleled safety in endovascular TAA repair, even for procedures where endografts have to be positioned in what physicians consider to be uncommonly tight aortic arches, which are notoriously difficult to properly seal.

In approximately 25 per cent of TAA patients, the aortic arch, which is formed like a reversed U, is exceptionally tight. Many currently available endografts are too rigid or have sealing stents that lack the radial force to conform correctly to the inner curvature of these tight arches, so that the graft does not seal off the aneurysm properly. As a consequence, surgeons in the past have been forced to remodel the arch with a balloon or use other aids to position the graft to reduce the risk of continued bleeding into the aneurysm and possible rupture, thus making the repair procedure longer and more complex.

With the TX2 Pro-Form's enhanced delivery system, these measures are no longer necessary. Patients receive a potentially safer, more effective procedure, and physicians have a more efficient and controllable treatment option due to the reduced procedural time that the TX2 graft with Pro-Form permits.

First-in-Man Procedure Completed

Prof. Ralf Kolvenbach at the Augusta Hospital and Catholic Clinics in Düesseldorf and a Professor at the University of Düsseldorf is the first vascular surgeon to have repaired a TAA with the TX2 Pro-Form. “Using the TX2 Pro-Form I was able to seal the patient's thoracic aneurysm in minimal time and with maximum control. The stent's new delivery system enabled me to place the graft to the precise location desired and fit it perfectly to the walls of blood vessel,” Prof. Kolvenbach explained. “With this stent graft system we have reached a new level of safety in thoracic aortic aneurysm repair.”

About the operation and device
The operation was performed on a 72-year-old male patient who was not a candidate for open surgical repair using thoracic endovascular repair (TEVAR), a procedure that continues to gain wide acceptance in the medical community, both in Germany where the first-in-man case was performed and around the globe. Open surgery, which requires a general anaesthetic and the creation of a large incision in the chest to allow a surgeon to clamp off the thoracic aorta and replace the damaged section with a surgical graft, can lead to serious complications and extended recovery times. Open surgery for TAA also has a higher patient mortality rate than endovascular repair.

Prof. Kolvenbach's patient was treated using minimally invasive endovascular therapy, with the medical team inserting catheters via one small incision in the groin to access the femoral artery. The physicians inserted a guide wire through the incision, then moved the delivery system carrying the stent-graft precisely into position over the guide wire, where the device was deployed to treat the aneurysm. This kind of endovascular repair frequently results in less patient discomfort and complications, a shorter hospital stay, lower mortality rates and faster recovery than undergoing the more traumatic open surgery.

Phil Nowell, global leader of the aortic intervention business unit of Cook Medical, explains: “Our aim is to provide surgeons with the best technology to treat patients with the greatest degree of control available in the industry. Through continuous product advancement in partnership with some of the world's leading vascular surgeons, we are thrilled to introduce this industry-leading advance in treating thoracic abdominal aneurysms. Many physicians are familiar with the relatively common problem of thoracic endografts forming a “bird's beak” gap along its underside when the graft is deployed into a tight aortic arch. We believe this improvement is a significant leap toward the solution of that problem.”

Notes:
What is a thoracic aortic aneurysm (TAA)?
An aneurysm is a bulge in the aortic wall caused by blood pressure pushing against a weakened area. Abdominal aortic aneurysms (AAA) in the abdomen are more common than a thoracic aortic aneurysm (TAAs) in the chest. There are three groups of thoracic aneurysms depending on location: ascending aortic, aortic arch, and descending thoracic aneurysms. When the aneurysm reaches a certain size (over 5.5 cm in diameter) it is at risk of rupturing. A burst aneurysm results in severe internal bleeding and can be fatal.

What is endovascular aneurysm repair?
To repair an aneurysm, an endograft is guided into the body with a catheter. Once inserted into the aorta, the endograft – a tubular fabric device supported by self-expanding metal stent bodies – seals off the aneurysm from within, relieving blood pressure against the weakened walls of the aorta, the body's main blood vessel, and reducing the risk of rupture.

About Cook Medical:
Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy, and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963 and operated as a family-held private corporation, Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.