Vascular Solutions to Distribute PolarCath Peripheral Dilatation System

November 4, 2014—Vascular Solutions, Inc. announced that it has entered into an agreement with NuCryoVascular LLC under which Vascular Solutions will serve as exclusive distributor of the PolarCath peripheral dilatation system in the United States. Vascular Solutions expects to begin sales of PolarCath to customers through its direct United States sales force during the first quarter of 2015.

The PolarCath system has US Food and Drug Administration (FDA) clearance for the dilatation of stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, and subclavian arteries), and for the treatment of obstructive lesions of polytetrafluoroethylene access grafts or arteriovenous dialysis fistulae. The PolarCath system is also indicated for postdeployed stent expansion of self-expanding peripheral vascular stents.

According to Vascular Solutions, the PolarCath peripheral dilatation system is composed of a disposable catheter, an inflation unit, and a nitrous oxide cartridge. The system is used to perform balloon cryoplasty, a catheter-based treatment that combines the inflation of a balloon with controlled cooling of the artery. PolarCath is used to dilate peripheral arteries with the same basic technique as balloon angioplasty, except that PolarCath uses nitrous oxide to inflate the balloon rather than liquid. The nitrous oxide cools the balloon to -10 degrees Celsius, which freezes the built-up plaque in the artery.

The PolarCath system was invented by James Joye, MD, who is Chief Medical Officer of the Fogarty Institute at El Camino Hospital in Mountain View, California. Dr. Joye and collaborators formed the company CryoVascular, Inc., to develop the device. The PolarCath system received its first US Food and Drug Administration (FDA) clearance in 2002. In 2005, CryoVascular was acquired by Boston Scientific Corporation, which discontinued manufacturing PolarCath at the end of 2012. NuCryo Vascular was formed by Dr. Joye and several of the former CryoVascular executives and employees for the purpose of acquiring PolarCath and resuming manufacturing of the device. NuCryo Vascular has established a manufacturing facility for PolarCath in Sunnyvale, California.

In the announcement, Dr. Joye commented, “Balloon cryoplasty has been shown in clinical studies and in everyday practice to be an important option for treating peripheral arterial disease, which can lead to below-the-knee amputations in patients with severe PAD. The controlled cooling of the plaque and artery wall provides three potential benefits: uniform vessel dilation with less vessel trauma; reduced vessel wall recoil; and induction of apoptosis, promoting the natural cell death of the smooth muscle cells that otherwise proliferate to cause restenosis.”