New visualization system for PAD patients

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Patient’s at the American Heart of Poland Hospital in Bielsko have been successfully treated with the latest technology developed by FoxHollow Technologies, the NightHawk system. This device enables real-time visualisation during arterial plaque excision in the lower legs.

The first-in-man use of the NightHawk system involved five patients from the Polish hospital and was overseen by a team of US interventional cardiologists, including FoxHollow’s CEO, Dr John Simpson, PI Professor Pawel Buszman and Drs John Simpson, Stefan Kiesz and Greg Robertson.

The new system combines real-time imaging with the company’s FDA-cleared SilverHawk Plaque Excision system. The combination of optical coherence tomography (OCT) technology with the SilverHawk system allows for plaque removal in patients suffering from blocked arteries in the lower legs.

“These initial procedures with the NightHawk, although early-stage, are very encouraging and consistent with our experience in pre-clinical studies. They demonstrate the potential for real-time visualization to enhance procedural results obtained with the SilverHawk for treating patients suffering from PAD [peripheral artery disease],” Simpson commented. “As a result, we believe the NightHawk may enhance our ability to treat PAD patients in the near-term and may allow us to expand the use of our products to other areas of the body.”

The NightHawk System utilizes fiber optic technology embedded in the catheter. While removing plaque, the physician has the ability to visualize the intravascular placement of the device within the vessel. Additional advantages of OCT include reductions in the use of potentially harmful X-ray imaging and contrast dye which may present potential risks to patients with pre-existing kidney or heart conditions.

“I was extremely impressed with the performance of the NightHawk and its ability to provide real-time images inside the arteries of the lower legs,” stated Robertson. “This enables the treating physician to visualize target tissue,” he added.

Earlier this year, FoxHollow announced a goal of achieving the first-in-man use of the NightHawk by the end of 2006. After early success was confirmed in pre-clinical studies, the company was able to realise this goal two months prior to the expected date.

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