Healthcare Industry News:  Cook 

Devices Interventional

 News Release - June 2, 2009

New Endograft Introduction System Enhances Physician Control During Minimally Invasive Treatment for Thoracic Aortic Aneurysms

First-of-its-kind deployment system designed to provide physicians with improved control when placing vascular stents during TEVAR procedures

BLOOMINGTON, Ind.--(HSMN NewsFeed)--In a development aimed at improving patient outcomes, physicians treating thoracic aortic aneurysms (TAA) will now experience a new level of control while placing endografts during thoracic endovascular repair procedures. With the launch of Cook Medical’s new Z-TRAK PLUS(TM) Introduction System, physicians are provided with improved maneuverability for controllable device orientation and deployment of the Zenith(R) TX2(TM) TAA Endovascular Stent Graft compared to earlier Cook delivery systems.

“The addition of the advanced Z-TRAK PLUS delivery system to Cook’s TX2 Thoracic Endograft System has given me a degree of control during stent-graft deployment that no other system I’ve used can match,” said Anthony Lee, M.D. “I’ve performed approximately 410 thoracic aneurysm cases using this improved delivery system, and am very pleased with the patient outcomes I’ve been able to achieve.”

The launch of the new introduction system comes as physicians are increasingly turning to thoracic endovascular repair (TEVAR) as the preferred, minimally invasive option for treating TAAs. TAAs occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon, often caused by a hardening of the arteries, high blood pressure, or trauma. Aneurysms of the thoracic aorta are potentially fatal, and open surgical repair is a highly invasive procedure many TAA patients cannot survive, making TEVAR their only treatment option. Untreated, five-year survival is estimated at between 10 to 15 percent.

The Zenith TX2 and the Z-TRAK PLUS Introduction System

Cook’s Zenith TX2 TAA Endovascular Graft, indicated for the treatment of descending TAA, is a tube of surgical graft material reinforced with self-expanding stainless steel Z-stents and an open stent with barbs designed to hold the device securely in place within the aorta after deployment. It is sized to the length of the thoracic aorta that needs to be covered to seal off the aneurysm. The graft is positioned in the aorta under the physician’s image-guided control across the aneurysm to prevent blood flow into the aneurysm. Cook’s Zenith TX2 is the only endograft 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 enables the graft to provide an excellent seal within the patient’s aorta.

“Properly aligning the stent graft for deployment is a crucial step during endovascular treatment for TAAs,” said Phil Nowell, global leader of Cook Medical’s Aortic Intervention strategic business unit. “Our new delivery system combines high kink-resistance and flexibility with a low coefficient of friction to offer control that rivals leading trackable devices used in coronary angioplasty. The added control provided by Z-TRAK PLUS enables surgeons to even make last-minute adjustments prior to stent deployment, regardless of scenario.”

Utilizing a hydrophilic-coated Cook Flexor sheath and super-elastic alloy inner cannula, Z-TRAK PLUS was designed to provide enhanced control and flexibility of entry and tracking. Cook’s renowned Flexor sheath features kink-resistant tubing technology for superior flexibility and trackability during use. A semi-deployed tri-fold configuration prevents a 'wind-sock' effect during deployment, thus enabling the physician to avoid slowing or stopping of the heart.

TEVAR – A Minimally Invasive Alternative to Open Surgery

Historically, open surgical repair has been the standard treatment for TAAs. Under this approach, 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.

TEVAR, a minimally invasive alternative to traditional, open surgery, involves an endograft guided into the body with a catheter to seal off the aneurysm from within. Patients undergoing TEVAR typically experience shorter recovery times and are also at a lower risk of the co-morbidities associated with open surgical repair. In particular, the Zenith TX2 device is inserted through 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 then placed in the weakened section of the thoracic aorta to relieve pressure on the aneurysm to reduce the risk of rupture. For more information, visit www.zenithstentgraft.com.

About Cook

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


Source: Cook Medical

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