Boston Scientific reports positive results of BTK Chill study

Boston Scientific has announced that results of its one-year below-the-knee (BTK) Chill study investigating its PolarCath peripheral dilation system that aims to dilate stenotic lesions in infrapopliteal arteries when the whole leg is being treated.

The study involving 108 patients resulted in an 85 per cent freedom from amputation rate alongside a 97 per cent success rate in decreasing vessel narrowing to less than half to improve blood flow.

Boston Scientific notes that critical limb ischemia results from circulatory disorder peripheral vascular disease that can cause an accumulation of plaque and reduced blood flow, with ensuing pain and disability and resulting amputation in extreme cases.

Tony Das, director of peripheral interventions at the Presbyterian Heart Institute of Dallas, commented that nearly 70 per cent of patients with critical limb ischemia traditionally undergo amputation as an initial treatment.

“The 12-month results from the BKY Chill study support the effectiveness of the PolarCath system, which offers a valuable alternative to amputation or invasive surgical bypass procedures in patients who have this painful, historically difficult to-treat condition,” he said.

In January 2007, the US Food and Drug Administration gave Boston Scientific clearance to expand the PolarCath system to include a 100 mm balloon to enable doctors to better deal with a wider range of arterial blockages.