Embolic Protection: Working the Guidewire With a Net

At this year's Paris Course on Revascularization (PCR), the leading European interventional meeting, embolic protection devices (EPDs) were among the prime subjects, in terms of clinical presentations and company exhibits. Some industry executives had predicted that Medtronic's acquisition last fall of PercuSurge would end the competitive race in this market before it really began. But judging by both the newer companies at the PCR and other recent entrants into this space, it appears that the battle has just begun. There are around 14 companies now competing in this space, six of which have received CE mark. Since none of these companies is on the US market, the initial competitive battle will be fought in Europe. Each of the major cardiology companies has already gotten into this area, generally through acquisitions. But there are also several start-ups that have come up with new technological approaches that are receiving favorable initial clinical reviews, so the debate remains open as to which of three approaches--occlusion balloons, filters, or proximal occlusion/reverse flow systems will ultimately prevail.

Until just a few years ago, interventional cardiologists and circus aerialists appeared to share the same mindset: both considered working their respective wires with a net unthinkable, an approach driven in part by the same motivation—to exhibit a mastery of their craft. Cardiologists believed a clinician's technique should be sufficiently precise to avoid dislodging any potentially risky emboli during percutaneous transvascular coronary angioplasty (PTCA) or other interventional procedures. The chance that emboli would come loose and cause a stroke or heart attack was deemed largely an issue of technique; the greater the physician's skill, the lower the risk. Until recently, this issue was only theoretical because no protection devices existed. But fortunately for patients, that mindset changed with the development of a variety of embolic protection devices (EPDs) and the accompanying data from clinical trials supporting their advantages. Today even leading interventionalists acknowledge and are promoting the use of EPDs.

Not only has the mindset of interventionalists changed, but so too has the competitive landscape. Some industry executives had predicted that Medtronic Inc. 's acquisition last fall of EPD pioneer, PercuSurge Inc. , while signaling the promise of embolic protection devices, would also take the wind out of the sails of would-be competitors [See Deal]. (See "PercuSurge: Picking Up the Pieces,"IN VIVO, May 1999 [A#1999800110 and "Medtronic Scoops Up PercuSurge," IN VIVO, November 2000 [A#2000800218

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