Cook responds to Medtronic AVE Talent challenge with extension of EVAR Portfolio-Zenith TX2

The best thing about blogging is the immediate feedback that one receives by way of comments and emails. I get a very representative sampling of opinions about various devices and vascular intervention topics. Some are from opinionative clinicians and some are from industry insider's with a distinct bias. And I don't categorically believe that just because someone works for a company and sells a product, that they can't have a genuinely defensible bias for their product. I think that's up to the readers to decide for themselves.

I like to share these periodically because the exchange is very helpful and informative whether you're a practicing physician or a member of the vascular device industry. The following comment was in response to my opinion that, at least transiently, the Talent Endograft by Medtronic AVE will erode the market share of Cook's Zenith Endograft in the area of Endovascular Aneurysm Repair (EVAR) for infrarenal aneurysms with challenging anaotomy of large proximal aortic neck diameter

....regarding Medtronic’s Talent device as a threat to Cook’s Zenith device. Cook Medical’s TX2 TAA endograft received FDA approval on May 23^rd and as a result of Cook’s strong position in the industry and positive clinical data, the device has become a top choice for vascular surgeons.  This is demonstrated by Cook’s announcement of the first commercial placement of the Zenith TX2 in the United States a few weeks ago (release below). 

To demonstrate the benefits of the device, Cook sponsored the STARZ-TX2 clinical trial, a multi-national trial designed to study the safety and effectiveness of the Zenith TX2. The trial results indicated that the TEVAR procedure, using the Zenith TX2, is a safe and effective alternative to open surgical repair for the treatment of thoracic aortic aneurysms in patients with suitable anatomy.  Cook expects to grow to 30% US market share in the TAA market through 2009.

Cook's press release regarding the first implant:

Cook Medical Announces the First Commercial Placement of the Zenith TX2® TAA Endovascular Graft in the United States

Company’s Breakthrough Thoracic Aortic Aneurysm Endovascular Graft was Successfully Implanted In Cleveland, Ohio

Bloomington, Ind., June 24, 2008 – Cook Medical, the established world leader in developing advanced technologies to treat diseases of the aorta, announced the first commercial placement of its Zenith TX2® TAA Endovascular Graft in the United States. The groundbreaking procedure was performed on a 69-year-old male patient by Sean Lyden, M.D., a vascular surgeon and specialist in endovascular aneurysm repair (EVAR) practicing at a major medical institution in Cleveland, Ohio. Cook’s state-of-the-art aortic endograft is designed specifically to treat patients undergoing thoracic endovascular aortic repair (TEVAR) for descending thoracic aneurysms and ulcers.

“The first placement of the TX2 in the United States showcases the advanced medical technologies Cook brings to the marketplace and marks a step forward in treating a broad range of TAA patients, safely and effectively, worldwide,” said Phil Nowell, global leader of Cook Medical’s Aortic Intervention business unit. “Dr. Lyden and others have told us they’ve been eagerly awaiting this device because it deploys with such accurate control and is actively fixed to the aorta, unlike competing devices. We believe this is a dramatic improvement for patients in a section of the aorta that really challenges endovascular devices for durability and that frequently offers only limited surgical repair options.

“With the highly skilled support of vascular surgeons like Dr. Lyden, we are now able to serve U.S. patients affected by TAAs (thoracic aortic aneurysms) or ulcers with the most minimally invasive alternatives available. Cook’s TX2 can be used on an additional subset of patients who may have been ineligible for treatment through open surgery, giving those affected by the disease, the opportunity to be treated with TEVAR,” Nowell added.

“The commercial release of the TX2 really made a huge difference for this patient,” said Dr. Lyden. “Using a small groin incision we were able to accomplish repair of his aneurysm in about 45 minutes. The two-piece device allowed customization to the patient’s anatomy to sit perfectly at the level of the left subclavian artery proximally and distally to near the celiac artery and prior repair. The hydrophilic Flexor delivery system passed through his anatomy to the treatment area with remarkable ease. This device will clearly make a huge impact on treating thoracic aortic disease.”

TAAs occur when a section of the aorta weakens and bulges outward like a balloon.  The Cook Zenith TX2, a reinforced fabric tube that is sized to the length of the aorta is used to seal off the aneurysm, where it helps to relieve pressure on the aneurysm or ulcer and reduce the risk of rupture.  The Zenith TX2 device is deployed from a catheter inserted through a small incision in the patient’s femoral artery. This procedure is far less invasive than traditional open surgery where physicians open the patient’s chest, clamp off and remove the diseased section of the aorta and replace it with a surgical graft.  Post-operative and post-discharge recovery times are typically shorter with TEVAR, which may help patients return to their normal lifestyle routines far faster than for those who undergo open surgery.

Comments

[Retro Jordans]

I really love your blog, Its great to find not absolutely everyone is just posting a ton of rubbish these days!

[Impotence causes]

A very good greetings to all readers. I think everyone should agree with me in thinking that the anatomy is the foundation of all learning, whether any medical science or a motor or other device, first to learn of any branch must be known physical or anatomical structure. From this it should start then delve into the subject, here is the importance of anatomy.

[Cheap viagra]

Good afternoon colleagues and friends, my name is Rich, I share with you my humble opinion on this article in person, when he started reading it I thought it might not be as interesting, but when developing reading I fully realize it's great, is great, I look forward to reading many more contributions like this.

[cheap ugg boots]

Prejudice is the child of ignorance.

[buy on taobao]

I can imagine TONS of uses for this

[moncler jackets]

I did not discuss that particular issue!!

[Supra Vaider]

In my mind you are the best*_*

[Air Jordan Retro]

Chers Michelle et Barry je vous ai rencontré les gars probablement comme cinq ou six ans auparavant à Lubbock, TX lorsque vous êtes venu à l'église Bruce Menefee, vous a chanté une chanson et j'ai pleuré et s'est effondré et je savais que mon Père céleste a été là pour me rattraper et ce soir il at-il de nouveau avec un Bless Piece Dieu vous pecious personnes.

[coach factory]

Long in my youth I traveled the pathway.

[Taobao.com china]

yes..another great post...really interesting read.

[taobao mall]

* be happy together is good enough. I am not asking for things that I could never get.

[Taobao English site]

i love tuareg lifes and their stories