Cook Medical Announces CE Mark Approval for New Thoracic Z-Trak™ Plus Introduction System For Its Zenith® TX2 TAA Endovascular Graft
December 4, 2006
UK – December 4 2006 – Cook Medical today announced receipt of CE Marking for the new Z-Trak™ Introduction System for its Zenith® TX2™ TAA Endovascular Stent Graft. Able to track easily well into the aortic arch, Cook’s revolutionary, next-generation Z-Trak Plus Introduction System provides market-leading trackability and maneuverability for precise, controllable device orientation and deployment of the company’s thoracic aneurysm stent graft.
“We’ve designed a delivery system for a thoracic stent graft that rivals even the most elegantly trackable devices used in coronary angioplasty,” said Barry Thomas, global leader of Cook Medical’s endovascular therapy products division. “Often the biggest problem encountered during endovascular treatment of thoracic aortic aneurysm is putting the device in place for deployment. By combining the Flexor sheath’s kink-resistance, flexibility and low coefficient of friction, the Z-Trak delivery system allows the physician to navigate the aortic arch more easily to deliver the stent graft to the precise location desired.”
Utilizing a hydrophilic-coated Cook Flexor sheath and super-elastic alloy inner cannula, the Z-Trak Plus system was designed to provide enhanced precision and flexibility of entry and tracking. Cook’s renowned Flexor sheath features kink-resistant tubing technology for superior flexibility and trackability during use.
Control is key to this system, allowing the operator to make last-minute adjustments prior to deployment of the stent graft, affording physicians the ability to achieve highly accurate placement at their own pace. The trigger-wire delivery mechanism allows adjustment of the endograft in a semi-deployed state for pinpoint accuracy. This is supported with a semi-deployed trifold configuration that prevents 'wind-sock' effect during deployment, thus providing the physician with the choice to not slow or stop the heart during deployment.
Cook’s Zenith TX2 TAA Endovascular Graft, indicated for treatment of descending thoracic aortic aneurysms and Type B aortic dissection, is a tube of surgical graft material reinforced with self-expanding stainless steel Z-stents that is made up of two parts. It is sized to the length of thoracic aorta that needs to be covered to seal off the aneurysm. The graft is positioned in the aorta across the aneurysm to prevent blood flow into the aneurysm. By combining existing market-leading Zenith® aortic stent graft technology, Cook, the largest privately held medical device manufacturer in the world, is unveiling new advances in the delivery, control and fixation to dramatically enhance TAA patient treatment with its new device.
The TX2 is the only stent graft with circumferentially anchoring barbs on both the proximal and distal segments of the device, which provides best-in-class fixation. Radial force from the self – expanding Z-stents allows the graft to provide an excellent seal within the patient’s aorta.
Michael P Jenkins, Consultant Vascular Surgeon at St Mary’s Hospital, comments: “One of the main problems with the thoracic aorta is the intersection between the arch and the descending segments. Getting a stent to conform to the shape of this crucial landing zone and then not deform or migrate is crucial for long-term durability. Packaging such a stent into a low profile delivery system, which can negotiate the potential tortuosity of the iliacs, infra-renal aorta, and distal thoracic aorta and yet retain accurate deployment characteristics is vital when there is no room for error. I believe the Cook TX2 has made significant advances towards these goals.”
Thoracic aortic aneurysms occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon. Historically, surgical repair has been the standard treatment. During surgery, the chest cavity is opened and the aorta is clamped, allowing the surgeon to sew a surgical graft into place to prevent a rupture. Surgical repairs may carry health risks for older patients as they likely suffer from other significant medical conditions.
Endovascular repair for treatment of thoracic aortic aneurysms is used instead of open surgical repair because it is less invasive and may result in fewer complications and quicker recovery. The Zenith TX2 device is inserted in a small incision in the groin to access the patient’s femoral artery. The device is guided into position through the patient’s arteries under fluoroscopy. The fabric-covered self-expanding stent-graft is placed in the weakened section of the thoracic aorta to relieve pressure on the aneurysm to reduce the risk of rupture.
Thoracic aortic aneurysms can be caused by the hardening of the arteries, high blood pressure, or trauma. Aneurysms of the thoracic aorta are potentially serious. Untreated, five-year survival is estimated at between 10 to 15%¹.
“With the European launch of our Zenith TX2 stent endograft, we’re continuing the Cook tradition of delivering the best, most versatile products for positive outcomes that are quick and effective for the patient,” added Barry Thomas. “As our commitment to developing and delivering innovative devices continues, we expect the TX2 to have a significant impact on uptake and success rates for patients requiring thoracic aortic aneurysm treatment.”
Cook’s Zenith TX2 TAA Endovascular Graft is also available as a limited access device in Australia and New Zealand at this time. Clinical trial results in the U.S. are being submitted soon to the U.S. Food and Drug Administration for U.S. market approval. For more information, visit www.zenithstentgraft.com.
About Cook Medical
With international headquarters in Bloomington, Ind., COOK® (www.cookgroup.com), the world’s largest privately held medical device manufacturer, is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, COOK has created innovative technologies for stents and stent-grafts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices. The company won the prestigious Medical Device Manufacturer of the Year Award for 2006 from Medical Device & Diagnostic Industry magazine.
¹According to the NICE guidelines on Endovascular stent-graft placement in the thoracic aortic aneurysms and dissections – 2005
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