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FoxHollow Technologies: The SilverHawk® Cuts Open a New Market

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biotechnology management case

Erik Miller, Dina Finan, and Michael Alvarez
Stanford University

Summary and key issue/decision: FoxHollow Technologies (FHT) was formed with a mission to remove plaque from coronary arteries. Just as FHT was completing the design of their SilverHawk® device and beginning early clinical trials, initial results from coronary drug-eluting stents were being reported and the outcomes were extremely positive. FHT had to face the fact that with limited capital resources, intense competition from the largest players in the industry, and a competitive product the likes of which had never been seen in the medical device field, the future of the company was clearly in doubt. Robert Thomas, the CEO of FHT, had to make a quick decision to change strategies while still trying to satisfy investors and the company’s founders and employees - many of whom believed that the new drug-eluting stent data were flawed. Thomas’ grandfather had recently undergone two amputations for vascular disease in his legs, and this inspired an alternative application for the SilverHawk. Breaking into the peripheral arterial disease (PAD) market seemed to be the answer to satisfy all interested parties, and most importantly, to address a huge unmet clinical need.

Company: FoxHollow Technologies, Inc.

Technology: SilverHawk®, a device for performing atherectomies to remove plaque from the inside of arteries to restore normal blood flow.

Stage of development at time of issue/decision: The initial product was developed as a device to treat the coronary arteries. There was approval in Europe only, and some trials had been performed with mixed results. The SilverHawk® device to treat the vasculature in the legs had not yet been developed, nor did it have any associated approvals.

Indication/therapeutic area: The SilverHawk device to treat the vasculature in the legs ultimately gained U.S. FDA approval for treatment of all arteries in the legs, starting with the Superficial Femoral Artery in the thigh area all the way down to the tibial arteries in the lower extremities.

Geography: Redwood City, California

Keywords: Silverhawk, PAD, Superficial Femoral Arteries, atherectomy, drug-eluting stents

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