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AAA stent graft market snags some conference spotlight


By Larry Haimovitch

Medical Device Daily Contributing Writer

November 16, 2009

The annual Canaccord Adams Cardiovascular Conference, held here last week, featured a diverse group of public and private companies addressing specific disease states within the cardiovascular space.

One of the largest and most rapidly growing device markets in recent years has been for endovascular abdominal repair (EVAR) of abdominal aortic aneurysms (AAAs). A smaller EVAR company, EndoLogix (Irvine, California), has successfully competed against three much larger companies—Medtronic (Minneapolis), Cook Group (Bloomington, Indiana) and W. L. Gore (Flagstaff, Arizona). Its CEO John McDermott presented at this conference. EndoLogix's share is estimated to be under 10%, while the other three companies divide up the rest, with Medtronic in the lead (see Table 1).

Table 1

Global EVAR Market Shares

Medtronic—36%

W. L. Gore—28%

Cook Group—28

EndoLogix—8%


Source:  Nellix presentation, CanAccord Adams Conference, Nov. 2009

McDermott noted that his company's market share has grown in recent years, despite the heady competition, with a dedicated and growing sales force, product line improvements and very solid clinical data showing that the device performs extremely well. McDermott, who joined the company about a year ago, noted proudly that the company's newest offerings Intuitrak and Intuitrak Express have made the procedure easier, faster and safer to perform.

These new offerings are buoying its financial results. To wit, in its recently reported 3Q09, it reported a spectacular 47% year-over-year revenue increase, growing much faster than the overall EVAR market, McDermott estimated that the global EVAR market in 2009 will approximate $726 million and he forecasted that it will grow 9% annually, reaching over $1 billion in 2013 (see Table 2). This estimate excludes the thoracic stent graft part of the market, which he projected at $380 million in 2013, bringing the combined AAA and thoracic stent graft market to about $1.4 billion in 2013.

Table 2

Global EVAR Market Estimates*

($ millions)

                                2009            2013

Domestic                $456            $644

International           $270             $377

Total                       $726            $1021

*--excludes thoracic aneurysms

Source:  EndoLogix presentation,
CanAccord Adams Conference, Nov. 2009

A relatively new private EVAR company, Nellix (Palo Alto, California), also presented here. CEO Bob Mitchell, who is highly experienced in this market, emphasized that the current EVAR product offerings are far from ideal due to leakage, migration, lack of stability and durability and the inability to treat difficult anatomies.

The proprietary Nellix device is quite different than the competition, featuring a unique set of components. Its system uses a durable polymer, an endobag that provides for sealed containment of the aneurysm, an endoframe that provides anatomical support without anchoring and a low profile, easy to use delivery system.

According to Mitchell, these attributes should enable Nellix to treat more patients and carve out meaningful market share.

The clinical results to date, albeit in relatively few patients, look very promising, with one-year follow-up on 29 patients showing no endoleaks, migrations or occlusions.

Nellix hopes to attain CE mark in 2010 and intends to start patient enrollment for its pivotal domestic trial also in 2010, with possible PMA approval in 2012.

"This market has huge potential and I believe that we are very well-positioned," Mitchell said.

Another vascular company, Lemaitre Vascular (Burlington, Massachusetts) commented on the EVAR market, though it is currently a very small part of its offerings. President Dave Roberts described Lemaitre as a "pure play in the peripheral vascular disease market," which he sized at about $3 billion globally.

In the EVAR market, Lemaitre markets the EndoLogix EVAR devices in Europe, with exclusive distribution through mid-2013. It also sells two other aneurysm stent grafts in Europe and ultimately hopes to reach the U.S. market.

The company has recently launched an innovative product in Europe for thoracic aneurysms, the Unballoon non-occlusive modeling catheter. This proprietary device can re-model a thoracic stent graft without occluding blood flow, a safety advantage over the occlusive balloons that are used today. It addresses a relatively small $30 million market niche but could be a significant contributor to Lemaitre, whose annual revenue is projected to reach about $50 million in 2009.

The company has filed a 510(k) for the Unballoon with the FDA, hoping for approval sometime in the first half of 2010.

 

2009 Canaccord Adams Cardiovascular Conference

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