Barry Thomas, global leader of Cook’s endovascular therapies division, presented a taste of the present and a glimpse of the future in his overview of the European and US endovascular markets. Cook has had a separate Endovascular Strategic business unit since July 2003, at which point Medtronic’s AneuRx dominated the US abdominal aortic aneurysm (AAA) stent graft market with a 70% share; Guidant’s Ancure was at 20% and Gore’s Excluder 10%. Two and a half years later and the playing field is much more level: AneuRx’ position has been eroded to 37%, Excluder is at 32% and Cook’s Zenith AAA graft is at 31%, according to Cook.
Looking solely at the 6,800 AAA grafts that were used in the third quarter of 2005, Thomas said that AneuRx accounted for 36.7% of implants, Excluder for 32.0%, Zenith for 30.9%, and Endologix’ Powerlink a minor 0.4%. With a total value for Q3/2005 sales of $85 million, this means that in Q3 alone Cook’s market share was worth around $27 million, said Thomas.
In Europe, 3,700 AAA stent grafts were used in Q3/2005. However there the market is dominated by Cook, with Zenith accounting for 41.3% of implants. Medtronic is second with a 35.8% market share, followed by Gore at 18.3% and Endologix at 2% (with 2.6% of the market given to ‘others’). In the European thoracic aortic aneurysm (TAA) stent market, there were 1,350 stent grafts implanted in Q3/2005. Medtronic accounted for 48%, Gore for 30%, while Cook took a 17% stake. Sales in the European TAA market in Q3/2005 were worth $17.9 million, making Cook’s share worth $3.1 million, claimed Thomas.
And these are growing markets, he stressed. Between the third quarters of 2004 and 2005 in Europe there was an 18% rise in endovascular procedures and an 11.9% drop in surgical procedures. Specifically, for AAAs, the number of endovascular procedures rose by 33.8% while surgery fell by 15.8%; for TAAs the rise was 35.8% while surgery fell by 14.5%. There were lesser, but still impressive, rises in the number of endovascular procedures and falls in those for surgery in the aortic-iliac and carotid arteries.
Towards the zenith
Looking ahead in Cook’s pipeline, there are several Zenith-related projects that should be realized in 2006, Thomas predicted. Top of the list is the second-generation AAA device, due to be launched worldwide in the second quarter. The company is also looking to launch its VOTT injection catheter and endovascular specific wires in the first quarter. Some devices are still in clinical trials, including the TAA TX2 two-piece endovascular graft, which has nearly completed enrollment for the Phase II trial, and the fenestrated AAA graft (with openings specifically to accommodate aortic-iliac morphology), which has completed Phase I, with results submitted to the FDA.
In terms of untested devices, the company is planning to submit an investigational device exemption (IDE) in the first quarter of 2006 for several innovations, said Thomas. These include the flairable stent for fenestrated devices and the bifurcated iliac side branch (ZBIS) graft, which should be entering a worldwide Phase I trial shortly. Further ahead, Cook is aiming to submit an IDE worldwide for a second generation TAA device in Q2/2006 and a balloon-expandable covered stent in Q3/2006.