New atherectomy device profiled in the Wall Street Journal

Shelley Wood

October 16, 2003

Thu, 16 Oct 2003 21:15:00

New York, NY - An inventor renowned for the devices he's successfully developed and marketed for the treatment of cardiovascular disease admits that his atherectomy device is "controversial" but says it will ultimately prove itself against stents in the coronary anatomy, according to a Dow Jones Newswire (DJN) profile that appeared in the Wall Street Journal.

"If you could take [the plaque] out, you would, rather than squish it and put a foreign body in," Dr John Simpson (FoxHollow Technologies, Menlo Park, CA) told DJN, arguing that this method is superior to leaving a stentdrug-eluting or otherwisein a vessel. "It's intuitive. The future is taking it out and putting it in a jar."

Twenty years have passed since Simpson invented his first atherectomy device and three decades since he invented the first over-the-wire angioplasty systems, the article notes. He also developed the Perclose arterial closure device, which he sold to Abbott Laboratories, and founded Advanced Cardiovascular Systems and Devices for Vascular Intervention, both of which he sold to Guidant. He is also chairman of Lumend, a company investigating devices for chronic total occlusions.

Now Simpson has an updated atherectomy device, the SilverHawkTM Plaque Excision System, developed by his latest company, FoxHollow Technologies. It is already on the market in Europe for coronary and noncoronary use and in the US for noncoronary applications only. A 700-patient trial evaluating the device for coronary lesions will form the basis of a US Food and Drug Administration application next year, the article notes.

What they say

Dr S Chiu Wong (New York Weill Cornell Medical Center, NY) told DJN that Simpson is "a great entrepreneur and inventor of devices," but he believes his atherectomy product will fill only a small niche in the coronary intervention market. "I don't think it will ever replace a drug-eluting stent in coronary artery disease. We know stents work based on evidence. The first trial was 15 years ago. The best [Simpson's device] can do is equivalent to a bare-metal stent, but the era of bare-metal stents is over. And no matter how you cut itpun intendedhis takes longer to use."

But Rich Ferrari, managing director at De Novo Ventures, is more sanguine: "Everyone thought drug-eluting stents would be a panacea. There's no question they'll be effective. But there are locations in the coronary and peripheral vessels in which a better approach would be to take some of the plaque out." He points out that an interventionalist could treat five lesions with the SilverHawk device for $1500, whereas treating the same number with a drug-eluting stent would cost $10000. "Why put in a $3000 stent when in the same locations you could remove plaque?"

Ferrari, who describes the end result of Simpson's atherectomy device as "a plate of linguini" with strips "two inches across," has invested $6 million in FoxHollow Technologies. Medical analyst Thom Gunderson, with US Bancorp Piper Jaffray,who also has a personal financial interest in FoxHollow, believes Simpson's new device could have a "big future" in peripheral artery disease but less so in the coronaries. "This is a little out of the ordinary, a little offbeat," Gunderson told DJN. "It will be an uphill battle to change the popular method."


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