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News — A new study presented today at the Cardiovascular Research Foundation's (CRF) Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, in Washington, D.C., has shown that plaque excision with a new device called the SilverHawk (SH) is beneficial as a primary therapy in revascularization of lower extremity peripheral arterial disease (PAD).

"We are very excited by the results of this study, because this procedure could potentially benefit millions of Americans living with PAD," said Roger Gammon, M.D., of Austin Heart, Austin, Texas, and lead investigator of the study. "SilverHawk dramatically reduced the severity of obstruction in these patients, and we have observed very promising results over 12 months."

PAD affects almost 12 million Americans, and diagnosis is critical, as people with PAD are six-to-seven times more likely to suffer a heart attack or stroke. PAD results from plaque that collects in the arteries and blocks blood flow in the lower extremities, causing severe leg pain, and ultimately gangrene, tissue loss and in some cases, amputation. An estimated 150,000 amputations are performed each year as a result of PAD, and amputation rates have been increasing despite efforts with previous treatment modalities. Patients with PAD face substantial treatment challenges, and only recently has plaque excision emerged as a potential treatment option.

Data for this study were collected through TALON, a prospective, non-randomized registry enrolling patients undergoing plaque excision for the treatment of lower extremity PAD with the new device. All patients were eligible for the TALON study, regardless of their clinical history or the severity of disease. Over 50% had diabetes and/or coronary artery disease, and 67% were smokers.

Immediate procedural results as well as target lesion revascularization (TLR) rates, or rates of subsequent procedures to re-open the blocked artery, at 12 months were evaluated. Twelve-month follow-up data were available for 335 patients with 658 lesions, or blockages, and demonstrated freedom from TLR in 79% of all blockages. Over 30% of procedures were for the most severe form of PAD—severe rest pain and/or tissue loss (critical limb ischemia or CLI). Sixty-nine patients had "pre-amputation" CLI, yet limb salvage was accomplished in 81% of these patients at 6 months.

"High procedural success rates, low complication rates, favorable intermediate results and low 12-month TLR rates indicate that the SilverHawk Plaque Excision System could be identified as a primary treatment for the revascularization of lower extremities in patients with PAD," according to Dr. Gammon.

Known as the SilverHawk (FoxHollow Technologies, Redwood City, Calif.), the device features a tiny rotating blade the size of a grain of rice that shaves away plaque from inside the artery. As the blade moves through the artery, the plaque collects in the tip of the device and then is removed from the patient altogether. Traditionally, PAD is treated with angioplasty, which would open a channel in the artery by flattening plaque against the artery walls but without removing it.

About CRF and TCTThe Cardiovascular Research Foundation is dedicated to research and education in the broad subspecialty of interventional cardiology and endovascular medicine. By establishing the safe use of new technologies and pharmacologic agents, CRF has played a major role in the remarkable advances in survival and quality of life for patients with cardiovascular disease. CRF is the sponsor of the 17th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, one of the largest interventional vascular medicine meetings in the world. For more information, please visit .