Cook Medical (Bloomington, Indiana) has been rolling out a wave of new products with little hesitation lately — most recently peppering the market with offerings from its Aoritic Intervention Unit and Endoscopy Division.
The company's' most recent attention grabber is the Cook Zenith TX2, designed for thoracic endovascular aortic repair. The device gained FDA approval late last month (Medical Device Daily, May 27, 2008).
Following the Zenith TX2 announcement, the company reported FDA 510(k) clearance for its Evolution controlled release esophageal stent system (MDD, June 10, 2008).
"The last few weeks have been very busy for Cook," Phil Nowell, global director & business leader of the company's Aortic Intervention Unit, told Medical Device Daily. "The market in the U.S. is an attractive one and we believe we offer an attractive alternative. The U.S. is always the largest in terms of market size."
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 Cook 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 TAAs in patients with suitable anatomy.
The Cook Zenith TX2, which includes a unique uncovered distal stent with fixation barbs to hold the device in place, helps to relieve pressure on the aneurysm and reduce the risk of rupture and in most cases, allow the aneurysmal sac to shrink.
TAAs occur when a section of the thoracic aorta weakens and bulges outward like a balloon. Ruptured aneurysms have a very high mortality rate, especially for TAA. The Cook Zenith TX2, a self-expanding tube of surgical graft material reinforced with metal stent bodies is sized to the diameter of the aorta and is used to seal off the aneurysm.
The device is deployed from a catheter inserted through a small incision in the patient's femoral artery. This treatment is far less invasive than traditional, open surgery where physicians open patients' chests, clamp off and remove the diseased section of the aorta and replace it with a surgical graft.
Cook is entering into markets that are dominated by other companies.
In the case of the Zenith TX2, the company's chief rival is W. L. Gore & Associates' (Flagstaff, Arizona) Gore TAG Thoracic Endoprosthesis, which was approved more than three years ago (Medical Device Daily, March 25, 2005). TAG is inserted through a small incision in the patient's groin, and a catheter delivery system is guided into position through the patient's arteries under fluoroscopy.
Once in position, a reinforced ePTFE-covered (expanded polytetrafluoroethylene), self-expanding nitinol stent is secured inside the weakened section of the thoracic aorta. This creates a new path for blood flow and relines the aorta. The stent-graft excludes the diseased segment from the pressure of blood circulation, thereby reducing the risk of a rupture.
"Gore's TAG is a first-generation device and surgeons we've talked to are not comforted that it can meet all of their needs," Nowell told MDD. "Our device has [several] critical advantages over other devices in this market."
Those advantages include the device being very trackable, leading it to be implanted with relative ease and active fixation a feature which keeps the device primarily stationary.
Plans call for 65 sites to be trained in the use of the TX2 by year-end, according to Howell.
"We think this device will do quite well," he said. "We've had tremendous feedback from surgeons wanting to use the TX2."
The company also goes head-to-head with Boston Scientific (Natick, Massachusetts), which has dominated the esophageal stent market.
Cook claims its advantage with the Evolution system is that it is the only esophageal stent with an internal and external silicone coating, which resists tumor ingrowth into the stent and helps the patient swallow food normally instead of just eating through a tube.
While Cook seems fairly certain of both products being successful, it should be noted that both the Boston Sci and Gore devices have had a solid presence in the market for years now, making Cook the equivalent of the new kid on the block.
But the company estimates that it will generate about $300 million in sales from the TX2 alone.
Cook's Aortic Intervention business unit already has experienced significant growth throughout the past year. For the year to date, the unit has increased its global sales by 28%.