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Home > Press Center > Press Releases from 2005 Annual Meeting > Results of plaque excision favorable compared with previous studies of other treatments for leg artery blockages

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Jill Goodwin
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One-year data from TALON, a multi-center study of patients treated with the SilverHawk™ Plaque Excision System, were presented today at the annual meeting of the Society for Vascular Surgery in Chicago. The results, presented by Dr. Venkatesh Ramaiah, a vascular surgeon at the Arizona Heart Hospital, showed a one-year clinical patency rate of 80 percent for all blockages treated with SilverHawk. A one-year patency rate refers to the percentage of patients who do not undergo a repeat procedure again within one year.  Patients who do not undergo a repeat procedure are considered “patent.”

Peripheral arterial disease (or PAD) is a condition that afflicts an estimated 12 million Americans. It occurs when plaque accumulates in the arteries and blocks blood flow in the legs. These blockages can result in severe leg pain, very limited physical mobility and ultimately, can lead to amputation. An estimated 150,000 amputations are performed each year as a result of PAD. The SilverHawk System is a minimally invasive method of removing the obstructive plaque and restoring blood flow to the legs and feet.

“The arteries in the legs are notoriously very difficult to treat. The TALON results far exceed what we have been able to achieve in the past with stents, balloons and even bypass surgery. These data suggest that a new gold standard is emerging for treating PAD,” Dr. Ramaiah said.

Published 12-month patency rates for previous treatments for PAD range from approximately 60 percent to 81 percent. For example, peer-reviewed published literature shows 1-year patency for surgical bypass at 77- 81 percent.   Reported 1-year patency for angioplasty and stenting in the leg arteries range from 60 – 67 percent.  

Of the 87 patients treated with SilverHawk and followed for 1 year, nearly 30 percent of the procedures performed were for the most severe form of PAD -- severe rest pain and/or tissue loss. Additionally, 36 percent of the patients had multiple blockages treated during a single procedure. All patients were eligible for the TALON study, regardless of their clinical history and the severity of their disease.  Over half had diabetes and/or coronary artery disease, and nearly one-third were smokers. 

The average time reported for the plaque excision portion of the procedure was 31 minutes. There were no serious complications reported, with 4.6 percent minor complications post-SilverHawk. For most patients in the 1-year follow-up group, plaque excision was used as the only therapy with just 3.5 percent receiving a stent following plaque excision.