In the sprit of making its existing devices better and improving patient outcomes, Cook Medical (Bloomington, Indiana) said it has received FDA approval to market its Zenith Abdominal Aortic Aneurysm (AAA) Iliac Flex Legs and Z-Trak introduction system, made for use with the Zenith Flex AAA endovascular graft. The products are designed to improve flexibility and conformability in the aorta and iliac artery, a tortuous section of patient anatomy, for patients undergoing endovascular aneurysm repair (EVAR), Cook said.

"It's a continuance of our ongoing daily development and improvements. That's one of the great things about Cook, for me personally, is that we continue to take our current designs and make them better. We're actually all about improved outcomes for patients," John Foster, a global product manager for Cook, told Medical Device Daily. "This is a great extension for our product range resulting in more flexibility and conformability of the stent graft and ultimately leads to improved outcomes for patients."

The Zenith AAA Flex Leg external stents are shorter than those of Cook's previous offering, with increased gaps between the stents – reducing the potential for the leg to kink – the company noted. The Flex Leg and Z-Trak system is available in the U.S. as well as in continental Europe and the U.K. The device, like the Zenith Flex main body, is constructed of polyester graft material supported by stainless steel Z-stent bodies. According to Cook, the Zenith Flex endograft main body with Flex Leg stents "represents an important engineering achievement in the pursuit of improved outcomes for patients undergoing EVAR."

"The body is very variable, everyone is a little different. As a result, [flexibility and conformability has] always been an area in the AAA market where we do try to seek improvement," Foster said.

Cook says its Z-Trak introduction system provides an integrated interface to the company's AAA platform, continuing its established maneuverability for "precise, controllable device orientation and deployment" of the company's endovascular stent graft. Precision is key to this system, Cook said, allowing the operator to make last-minute adjustments prior to deployment of the stent graft, affording physicians the ability to achieve highly accurate placement. The trigger-wire delivery mechanism allows adjustment of the endograft in a semi-deployed state for pinpoint accuracy, according to the company.

"There are actually two things that we're introducing here, the changes to the actual graft which improve the flexibility and conformability, but we've also introduced this new Z-Trak introduction system," Foster said.

He said the Z-Trak is similar to the existing introduction system but with more of an industrial design that makes it more comfortable and it also has a longer sheath length.

"FDA approval of the Z-Trak introduction system and Zenith AAA Flex Leg brings the flexibility and deliverability of our market-leading AAA platform to U.S. physicians and their patients," said Phil Nowell, global director of Cook's Aortic Intervention strategic business unit. "Our commitment to creating innovative devices and technology to help physicians perform minimally invasive diagnostic and therapeutic procedures for aortic aneurysms that improve patient outcomes and make the benefits of EVAR available to an ever-widening cohort of patients is revolutionizing the industry and creating a new gold standard for the treatment of this life-threatening disease."

According to Cook, post-operative and post-discharge recovery times are typically shorter with EVAR which may help patients return to their normal lifestyle routines far faster than for those who undergo open surgery.

Cook has been busy rolling out new products lately, particularly from its Aortic Intervention unit. In May, the company reported FDA approval of its Zenith TX2 Thoracic TAA Endovascular Graft to treat patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair (Medical Device Daily, May 27, 2008).

No Comments