Vascular Solutions Rolls Out PolarCath Peripheral Dilation System in U.S.

Vascular Solutions has launched the PolarCath peripheral dilation system in the U.S., under an exclusive distribution agreement with the NuCryo Vascular, the device’s manufacturer. The system, which is used to dilate and modify atherosclerotic plaque, is expected to have sales this year in the $3 million to $5 million range, the company said Monday.

The device is indicated for use in dilating stenoses in the iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries and for treating certain obstructive lesions and fistulae. It is also indicated for expanding stents that are already in place, the company said.

The product launch involves 0.014-inch guidewire-compatible PolarCath balloon catheters that target below-the-knee interventions. The devicemaker plans to introduce 0.035-inch versions targeting above-the-knee issues later this year.

The PolarCath system was approved by the FDA in 2002, but production was discontinued in 2012 following developer CryoVascular’s purchase by Boston Scientific in 2005. NuCryo Vascular was formed by former CryoVascular executives with the intention of bringing PolarCath back to the U.S. market. — Jason Scott