FDA grants approval to Cook for Pro-Form version of TX2

On Monday July 27, 2009, Cook medical announced that they received FDA approval of the Pro-Form version of the TX2 thoracic endograft. The TX2 device was approved spring of 2008. Since that approval Cook has been aggressive in modifying the device three times to meet the anatomic challenges of difficult aortic arch anatomy. These changes are essential to assisting the clinician to broaden the population of patients that can be treated with minimally invasive technology and to produce durable results following repair.

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Device Description

The Zenith TX2 TAA Endovascular stent graft is designed as a two-piece modular system, although implantation of a single device may be sufficient for focal thoracic aortic lesions (see fig 8). The Zenith TX2 endograft is constructed of Dacron fabric covered by stainless steel Z-stents. In this device, the proximal end is covered and has stainless steel barbs protruding through the graft fabric (fig 10), which anchor the graft directly to the aortic wall. This also protects against distal stent graft migration during high-velocity systolic blood flow. The device uses an active fixation mechanism with external barbs oriented in opposing directions and designed to engage the aortic wall to decrease the risk of proximal and distal migration. Full deployment of the proximal stent is released by pulling a trigger wire once the optimal graft position is confirmed. The stents are modified Gianturco Z-stents, with small gaps left between each stent to allow some flexibility. Each end of the graft is held within a cap; inadvertent release during positioning within the aorta is prevented by a safety catch. The full length of the graft material is stent supported to prevent graft torsion or compression. The placement of the stents relative to the fabric is varied along the length of the device. At the ends of the endograft, the stents are sewn inside the fabric, whereas in its midportion, they are outside the fabric. The intent of this design was to optimize fabric apposition to the aortic lumen and fabric-fabric interstent junctions. The Zenith TX2 Proximal Component is available in diameters ranging from 28 to 42 mm and lengths from 12.0 to 21.6 cm. The Z-Trak delivery systems for the Zenith TX2 device have profiles between 20F and 22F. Device deployment is achieved by withdrawing an external sheath.source

The three iterations of the delivery system to date have included the 1) Flexor sheath 2)Z Trac Plus with a nitinol cannula for better trackability and the new 3) Pro-Form

Mr Leonard described the Pro-Form as a modification to the lead stent. The internal tracking wires teather the distal end of the first stent into the graft to pull the distal end inward so that the inferior aspect of the graft "hugs" the inferior wall of the aortic arch. The inferior wall of the aortic arch is the achilles heal of the tight aorta and in may leave the graft prone to mal apposition and subsequent migration or endoleak development

Bench testing with aortic flow models and curved radii models were favorable and the short term European results under very challenging anatomic conditions were favorable enough to get FDA approval on this device modification

The clincal launch is scheduled for November to coincide with the Veith meeting. The graft will be available at selected centers prior to that time. The plan is to roll out the new modification and exchange for the "old" version which will have the exchange completed by January of 2010

Perhaps the most promising use of this technology remains to be seen in the form of treatment for aortic dissection and thoracic aortic transections and traumatic disruptions. Cooks states that a phase I trial for this pathology is taking place at University of Florida, Mass General and Thomas Jefferson with the recent addition of Cooper Medical Center and The Cleveland Clinic

Special thanks to Mr Leonard for his time explaining this new and exciting technology

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On Monday July 27, 2009, Cook medical announced that they received FDA approval of the Pro-Form version of the TX2 thoracic endograft. The TX2 device was approved spring of 2008. Since that approval Cook has been aggressive in modifying the...

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