At the recent VEITHsymposium, Barry Thomas from Cook Medical’s Aortic Intervention Division, presented an overview of the global market events relating to abdominal aortic aneurysm (AAA) stent grafts.
To begin, Thomas highlighted Cook Medical’s achievements for 2006, which included the first AAA stent graft approved for sale in Japan, FDA approval for Cook’s Zilver nitinol vascular stent, and the signing of its Neugene license with AVI Biopharma for vascular disease.
Following this, he presented an overview of Cook’s aortic intervention strategic business unit, showing global sales for the company’s Zenith AAA stent graft up by more than 20% in comparison with results for 2005. In Europe, sales increased by an equal amount, and in the US and Canada, sales had increased by just under 20%. Thomas noted that October was the “best month on record”. A 100% increase in Japan is the result of Cook’s Shonin filing (regulatory approval) granted in July 2006 by the Japanese Ministry of Health, Labor, and Welfare. The Zenith endovascular graft system was the first and currently, only device available for endovascular repair of AAA in Japan. In January 2007, the company was granted preliminary hospital reimbursement for endovascular repair (EVAR) of AAA in Japan. Cook expects full reimbursement in Japan in March 2007, which will precipitate a complete rollout of the Zenith stent graft system across the country.
“Cook was first to the market with this life-saving medical device technology in August 2006 and in just four months we have hit another major milestone with this news of preliminary reimbursement,” said Thomas, global leader of Cook’s Aortic Intervention Division. “Our rapid progress in Japan is the direct result of a collaborative effort involving Cook’s worldwide endovascular team, and our Japanese distributor, Medico’s Hirata Co Ltd.” The Zenith endograft will be reexamined three years after the approval date. A requirement of approval includes providing detailed clinical training to Japanese physicians to ensure their safe and effective use of the device.
Next, using third-party research data, Thomas compared US market share results at the end of 2005 with US results from the end of the third quarter 2006, for the AneuRx, Excluder, Zenith and Endologix stent grafts. According to Thomas, results demonstrated a close battle between Medtronic’s AneuRx, Gore’s Excluder, and Cook’s Zenith at the end of 2005, with the Excluder only just dominating the market with a 35% share, followed by Cook (33%), Medtronic (31%) and Endologix’s Powerlink 1%. Results for 2006 showed an even closer battle between Gore and Cook, each comprising 38% and 37% of the AAA stent grafts used in the US respectively.
Thomas reported that in the US, more than 6,000 AAA stent grafts were implanted during the third quarter, 2006. The total endovascular AAA graft sales in the third quarter, 2006 was more than $80 million ($79 million in 2005). Cook contributed just over $30 million to the total market share, an increase of 28% from last year ($24 million).
In Europe, Thomas explained that 4,500 AAA stent grafts were implanted during the third quarter, 2006. Cook contributed to 47% of total implants, followed by Medtronic (32%), Gore (17%) and Endologix (2%). Total endovascular AAA graft sales for the second quarter in 2006 were $31.5 million ($28.5 million in 2005). Cook contributed just under $15 million to the total ($11.9 million, 2005), an increase of 24%.
In terms of market specifics (2005 vs. 2006), Thomas reported that sales in Australia, USA, Canada, UK and Taiwan were up between 13%, and 100% respectively. In Belgium sales were down by nearly 20% due to impact of reimbursement, and similarly, sales were also down in France by 1%.
Thomas briefly outlined future Cook endovascular projects, explaining the second generation AAA Zenith device is expected to be launched in Australia in the forth quarter of 2006. In the US, the TX2-Flexor/Captor will be submitted to the FDA in November, 2006. Also in the US, the 36mm Flex Stent System was launched in November, 2006, and the Bifurcated Iliac Side-branch stent is expected to receive CE approval in Europe.
In summary, Thomas explained that the future of Cook aortic intervention will focus on disease in the ascending aorta (aneurysm and dissection), treating the thoracic arch, dissection in the descending aorta (Type B both chronic and acute), and treating thoraco-abdominal disease.