Boston Scientific's PolarCath peripheral dilatation system has demonstrated positive results from the COBRA clinical trial, which investigated post-dilation of nitinol stents using CryoPlasty therapy.
CryoPlasty therapy uses nitrous oxide to fill an angioplasty balloon within a blocked artery to treat atherosclerotic lesions in the peripheral arteries.
The COBRA trial randomised 76 patients with 90 superficial femoral artery lesions to CryoPlasty therapy or conventional balloon angioplasty for post-dilation of nitinol stents.
The prospective, randomised, multicentre trial showed a 47% relative reduction in binary restenosis rates for patients treated with PolarCath system compared to stenting with conventional balloon angioplasty.
In the study, the primary endpoint was the rate of binary in-segment restenosis determined by duplex ultrasonography, while the secondary endpoint included change in the ankle-brachial index from baseline in 12 months.
Principal investigator of the study Subhash Banerjee said CryoPlasty therapy can reduce binary restenosis at 12 months.