Medical device companies agree the fast-growing peripheral vascular (PV) market is the place to be. The question is how are they going to get there?
Devices that open clogged arteries below the waist are growing 10 percent to 12 percent a year, more than twice the growth rate of coronary products. Doctors have been generally unhappy with the lack of durable, easy-to-use PV stents, analysts say.
But what makes the PV market so interesting is that it’s completely up for grabs.
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The market is divided between big manufacturers like Boston Scientific and Johnson & Johnson who adapt existing coronary technologies to treat PV-related diseases and smaller, emerging companies like ev3 Inc. of Plymouth, Minn., Cook Medical and C.R. Bard who concentrate solely on the PV market.
Companies like Boston Scientific feel their global distribution and long-time experience with stents and balloons give them the edge. Over the past 15 months, the Food and Drug Administration has granted the company three PV-related pre-market approvals (PMAs), including its Sterling ES and Sterling SL stents, and Express LD Iliac stent, the first FDA-approved pre-mounted balloon expandable stent designed to treat atherosclerotic iliac disease (plaque builds within the arteries that supply blood to the legs, causing poor blood flow and leg pain).
The company is also conducting a major clinical study on a stent for the superficial femoral artery (SFA). With 10 product launches scheduled for 2010, Fitzgerald said he expects Boston Scientific to match market growth rates this year and exceed them in 2011.
However, firms like ev3 are growing faster because of their innovative technologies designed specifically for PV patients. For example, Bard is also currently the only company to sell a FDA-approved SFA stent in the United States.
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Medtronic Inc. of Fridley, Minn. seems to be doubling down. The company said Wednesday that the FDA approved its Complete SE Vascular Stent System for the iliac (pelvis) arteries. At the same time, Medtronic also announced it completed its $500 million acquisition of Italian cardiovascular device maker Invatec. Founded in 1996, Invatec specializes in PV devices.
“FDA approval of the Complete SE Vascular Stent System for a peripheral indication marks a successful milestone in our [peripheral artery disease] clinical research program,” Sean Salmon, vice president and general manager of Medtronic’s coronary and peripheral business, said in a statement. “Following our acquisition of Invatec, this approval augments Medtronic’s offerings in a large and growing market where patients are significantly under-diagnosed and could benefit from expanded treatment options.”
So who’s going to win? That depends on what doctors will prize more: big, familiar brands like Boston Scientific and Medtronic, or PV-specific companies. My guess is it will come down to clinical evidence. Since ev3 can’t match Medtronic on distribution or price, the company will have to prove its PV technology is somehow superior than finding new uses for coronary stents and balloons.
For example, PV stents need to be more flexible and durable than heart stents because of the shifting variables associated with legs and feet, including pressure, motion and dexterity.
Let the games begin.