NEW YORK — John Simpson, MD, PhD, said his staff wouldn't let him talk about the NightHawk first in his presentation at last week's Piper Jaffray Health Care conference because he was so excited about it that it would take up the whole half hour allotted to him.

So we'll explain the NightHawk last too.

Besides, just as interesting was the Power Point slide used by Simpson, CEO and founder of FoxHollow Technologies (Redwood City, California), early in his presentation.

The slide featured multiple images of very queasy-making stuff, and Simpson wryly offered to provide any of these images "in screen saver mode." Nobody seemed very interested.

Pictured in detail were various icky, yarn-like, wormy-looking messes, with incredibly unpalatable hues and looking scarily alive — all samples of plaque taken from the peripheral vasculature of patients via the FoxHollow SilverHawk device.

The SilverHawk is the flagship system developed by FoxHollow for this procedure and so far winning the largest headlines for the company — via its recent deal with Merck (Whitehouse Station, New Jersey) in which the big pharma company acquired an 11% stake in the company and committed to a research agreement that could bring the device company up to $100 million over the next four years.

The agreement calls for FoxHollow to supply samples of plaque materials excised by the SilverHawk, which will be supplied to Merck and examined to better understand the biology of plaque — especially "vulnerable" plaque — and develop drugs to treat peripheral artery disease (PAD), a vasculature problem increasingly being brought to the front burner of the "unmet needs" category.

The device "cleans" the peripheral arteries by "shaving out plaque so that blood flow can be reestablished and normalized," Simpson said.

And he showed the beneficial results with before and after images of a 92-year-old woman's leg that was healed after SilverHawk treatment, and standard treatment could not (not bothering to offer the ugly "before" in screen saver mode.)

Simpson also detailed the unhappy numbers for peripheral arterial disease (PAD): 150,000 in the U.S. receiving bypass surgery, 400,000 treated via balloon/stent, and 50,000 amputations, which Simpson termed "a usual therapy, but I don't even call it a therapy — it's an event, tragic and leading to a large number of bad outcomes." For most of these patients, he noted, it is a story of repeat hospitalizations and huge costs.

He said that using its technology to prevent these results is the "commitment" of FoxHollow, and he reported that about 60,000 cases will be treated with the SilverHawk in 2006.

He estimated that a patient pool of 700,000 of the 2.5 million PAD sufferers is appropriate for SilverHawk treatment, but there may be "closer to 10 million with the disease undiagnosed."

Using an animation, Simpson showed how the device is moved into the vasculature, and a "cutting element" is then elevated to remove the yellowish plaque from the arterial wall. This "spinning device is advanced through the artery, shaves off material, and the process is repeated as many times as you need to [the vessel]."

This can be done "maybe 20 times in a profusely diseased vessel," he noted, with a key benefit that the interventionalist can manipulate the device with "standard technique."

He added: "Our device doesn't discriminate, it doesn't care, whatever is obstructing the artery, it's coming out."

Turning to the future, Simpson said the company will be developing trials that compare the SilverHawk against bypass surgery, and eventually compare it against the use of peripheral stents when these are "approved for PAD."

Further out, he indicated other possibilities: use of the technologies to treat the coronary arteries; development of a device/paclitaxel drug combination, with the advantage of "not leaving a foreign body behind," he said — referring to the problem of thrombosis with drug-eluting stents; use of the company's technologies for treatment of the coronary arteries; and the development of a "RockHawk," a device for cutting through calcium and combined with "embolic protection."

Then came the excitement.

Simpson described the NightHawk, so named because it provides a sort of arterial night vision by adding to the SilverHawk an optical fiber, "so we can see what we're cutting to supplement the information we would ordinarily get."

Providing a detailed view of the artery being cleaned and the irregularities of the target plaque will provide more precise cutting, "with certainty," he said, and reduce procedure time — that certainty he again demonstrated with slide images of a treated vessel.

The optical fiber in its first use will be behind the cutter, he said, and then moved forward in the next-generation device.

Compared to the need to take after-procedure "single-plane" angiogram images of the vessel, the NightHawk offers "quite a breakthrough for us," Simpson said.

While acknowledging that the word "revolutionary" is too often used, he said that the "detail for the structure of the arterial wall is literally revolutionary — I promise you this is not what you've ever seen before in interventional treatment. The revolutionary part is a 10-fold improvement in resolution."

A FoxHollow executive told Diagnostics & Imaging Week that the company has begun a small trial of NightHawk in Poland, and will soon launch a larger trial there, and has its sights set on a trial in the U.S. in 2007.

Simpson said that the broad opportunities for FoxHollow's technologies are to gain a greater understanding of vulnerable plaque and using this information to stratify patients "to make better, more accurate determination of what the patient should have" by characterizing "the biological opportunities."

And referring to the various unwholesomely colored samples that the company is sending to Merck, Simpson asserted: "plaque does not belong in an artery, it belongs in a jar."

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