Cook Medical (Bloomington, Indiana) reported the launch of its new Z-Trak Plus Introduction System, a device that will help with improved maneuverability for controllable device orientation and deployment of the Zenith Tx2 TAA Endovascular Stent Graft.
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.
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.
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%.
"This is an improvement ... but there is no actual change to the stent itself," Phil Nowell, global leader of Cook's Aortic Intervention business unit, told Medical Device Daily. "The delivery system has a new tip, which allows it to track around the artery more [effectively]. It opens up the TEVAR procedure to many more patients."
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.
The company said that the 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.
The Zenith was given FDA approval a little more than a year ago (Medical Device Daily, May 27, 2008).
Using 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 Flexor sheath features kink-resistant tubing technology for 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.
"Properly aligning the stent graft for deployment is a crucial step during endovascular treatment for TAAs," Nowell said. "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."
The Z-Trak Plus has already been released in Europe and has had CE Mark indications for the last two years.
Cook's Aortic Intervention business unit has experienced significant growth throughout the past year. Last year the unit has increased its global sales by 28% (MDD, June 12, 2008).