Embolic Protection: Unmet Clinical Need or Unneeded Technology

Full article reprinted from Start Up - November/December 2009  

While the debate continues about whether embolic protection devices are really necessary, the space continues to generate interest from investors, start-ups and large companies looking for new technologies. Despite the unfulfilled promise of the past decade, interest has spread to new interventional applications such as percutaneous heart valves, indicating that this area remains a viable opportunity for start-ups. Read more...

Embolic Protection: Unmet Clinical Need or Unneeded Technology

Full article reprinted from Start Up - November/December 2009  

While the debate continues about whether embolic protection devices are really necessary, the space continues to generate interest from investors, start-ups and large companies looking for new technologies. Despite the unfulfilled promise of the past decade, interest has spread to include new interventional applications such as percutaneous valves, indicating that this area remains a viable opportunity for start-ups.

** Ten years ago, the first embolic protection devices were born, and they have since provided a fertile and lucrative field for start-ups, many of which have been acquired by the large cardiology companies.

** But for the large companies that now sell the first-generation devices, the field hasn't lived up to its promise, not even in carotid stenting, where the ability to prevent stroke makes the use of these devices most compelling.

** Part of the problem is that clinical trials have neither dramatically nor consistently born out the clinical value of the first-generation devices, resulting in physicians not widely adopting these products for most interventional procedures.

** New start-ups believe that what holds back adoption is simply the need for better technology, and are betting that they can engineer novel solutions to the problems current devices face that will translate into demonstrable clinical benefits in both existing and emerging interventional procedures, such as percutaneous heart valves.

Embolic protection devices (EPDs) designed to capture the debris that breaks off during percutaneous revascularization procedures didn't exist 10 years ago, and now they make up a crowded category, particularly for an area whose promise remains largely unfulfilled. All the major cardiovascular companies jumped into the game by acquiring first-generation start-ups offering distal filters and occlusion balloons ( see Exhibit 1), in an effort to capture portions of what was originally seen as a market in excess of half a billion dollars.

What made the original vision of embolic protection devices compelling was not just the size of the market but the potential to expand the use of a variety of existing and emerging percutaneous procedures. In 1999, officials from PercuSurge, one of the pioneers in this space, assessed the opportunity for their embolic protection device for IN VIVO magazine. At a time when the start-up had some sales outside the US and was finishing up clinical trials in the US, company officials described a $700 million market opportunity for itself from selling a $1,000 device used in 325,000 percutaneous interventions in saphenous vein grafts and 350,000 carotid stenting procedures. ( See "PercuSurge: Picking up the Pieces," IN VIVO, May 1999.) For PercuSurge and others, the percutaneous treatment of acute myocardial infarction (AMI) remained an additional future large market possibility. That discussion took place two years prior to PercuSurge's acquisition by Medtronic Inc. for $225 million, one of this sector's first success stories.

Ten years later, the entire US market is worth less than $200 million, including both coronary and carotid procedures, and there is nothing to show in acute myocardial infarction but a very long list of failed clinical trials. Yet, start-ups continue to emerge in this area and venture investors continue to back these companies, despite the previous disappointments and continued uncertainty. This continuing interest can perhaps best be explained by the fact that there is a compelling underlying logic to the notion of using devices to protect against the risk of debris floating upstream to the brain and causing a stroke. Someone just has to come up with the right technology to accomplish this goal, or so companies and their investors believe.

- Mary Stuart

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Companies mentioned in this article:

Abbott Laboratories Inc.

Angioslide Ltd.

Bayer AG

Bayer Corp.

Bayer HealthCare LLC

Bayer Schering Pharma AG

Schering AG

Medrad Inc.

Boston Scientific Corp.

Cook Group Inc.

Covidien Ltd.

Edwards Lifesciences Corp.

Embrella Cardiovascular Inc.

Gardia Medical Ltd.

Genesis Medical Interventional Inc.

InspireMD Ltd.

Invatec SRL

Johnson & Johnson

Lumen Biomedical Inc.

Medtronic Inc.

Ventor Technologies Ltd.

Micrus Endovascular Corp.

Pathway Medical Technologies Inc.

St. Jude Medical Inc.

WL Gore & Associates Inc.

ev3 Inc.

FoxHollow Technologies Inc.

About Start Up

No publication reviews leading edge companies and technology better than START-UP. Each issue of START-UP profiles the most important new product companies, identifies the hottest technology areas, reviews funds flowing into private companies and investment trends, and reports on university tech transfer licensing. Industries covered: pharmaceuticals, biotechnology, medical equipment & devices, and in vitro diagnostics.