NuCryo Vascular said that the PolarCath Peripheral Dilatation System has secured US Food and Drug Administration (FDA) clearance in 2002 to dilate stenosis in the peripheral vasculature including iliac, femoral, popliteal, infrapopliteal, rena and subclavian arteries.

The system is also used for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae.

The company said that the PolarCath System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

NyCyro Vascular operations manager Tri Tran said: “The extended catheter launch is a huge milestone for NuCryo Vascular as it not only improves the efficiency of our internal manufacturing process, but it also reduces inventory and costs to our expanding and loyal customer base.

“The extended catheter launch improves our manufacturing capacity by nearly 50 percent, which is critical as we ramp up to meet the increased demand.”

NuCryo Vascular has also raised a Series B round of financing which is expected to provide the necessary working capital to support the growth of the PolarCath Balloon Dilation System while reaching corporate profitability in 2019.

“Our supply chain has been optimized to meet our growing forecast, so the Series B financing round is critical as we prepare to scale in 2019,” said Kevin Beedon, general manager and executive vice president of NuCryo Vascular. “Scaling the operation will allow us to meet the growing demand for our system while lowering costs for our customers.”

According to the company, the PolarCath system is an innovative, time-tested and proven peripheral angioplasty balloon that combines mechanical angioplasty and precise cryotherapy for the treatment of peripheral arterial disease.

First Coast Heart & Vascular Center interventional cardiologist Dr. Van Crisco said: “I am very excited for the PolarCath Extended Catheter as it provides a safe and effective anti-restenotic alternative to other currently available treatment options.

“The extended catheter will not only make an already easy-to-use system easier, but by lowering the cost to the customer, it enhances the position of the PolarCath system in my peripheral treatment algorithm in the hospital as well as the office-based lab.”

The company claimed that its PolarCath balloon has been used in over 270,000 procedures since its initial launch in 2002.