CryoVascular Systems

Alternative treatment to balloon angioplasty

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Using a new form of angioplasty to open blocked arteries by cooling and dilating them, the PolarCath™ Peripheral Transluminal Angioplasty System appears to be more successful and result in fewer complications than conventional balloon angioplasty. The new system was developed by CryoVascular Systems, Los Gatos, Calif.

"At nine months, 85 percent of the treated lesions remain patented, which is significantly better than expected patency rates for either angioplasty or stenting," says John Laird, MD, director of peripheral vascular intervention at Washington Hospital Center, Washington, D.C., and principal investigator of the study. "In addition, significant dissection occurred acutely in only six percent of the patients, which is less than half of the dissection rates reported for conventional angioplasty." Although it is early, Laird adds, the results look promising and may demonstrate improved long-term outcomes compared to conventional therapies.

The PolarCath system involves the same minimally invasive approach as balloon angioplasty. However, PolarCath has a specially designed balloon system that is advanced to the site of blockage and filled with liquid nitrous oxide, which evaporates into a gas upon entering the balloon. The evaporation process cools the balloon to sub-freezing temperatures, thereby cooling the plaque and vessel wall as it dilates the vessel. This is believed to crack the plaque and aid in reshaping it with minimal injury to the vessel wall.

In traditional angioplasty, the balloon is filled with saline and the walls of the clogged artery are compressed, causing injury in the vessel, which triggers an inflammatory response. This inflammation can cause a reclogging of the artery or restenosis. It's estimated that more than 40 percent of femoropopliteal angioplasties (angioplasty in the legs) result in restenosis within nine months to one year.

To date, more than 250 patients have been treated with the PolarCath System for blockages of blood vessels in the legs with promising results. A study conducted to evaluate the safety and effectiveness of the new device has been underway for more than one year. This multi-center study involves 15 sites in the United States and one site in Germany. The final study results are expected this summer.

"For a number of years, angioplasty has been a good, minimally invasive alternative to surgery, but restenosis continues to be a stubborn problem," says Giancarlo Biamino, MD, PhD, director of clinical interventional angiology at Herzzentrum Leipzig at the Clinic for Heart Surgery and Cardiology in Germany. "It's early and we are continuing our research, but it seems like a very promising therapy that initially lowers the rate of dissections and consequences of stent implantation."

The PolarCath system received marketing clearance from the U.S. Food and Drug Administration last September and will be commercially available in the United States this year.

For more information, call 408-376-3675 or visit www.cryoinc.com.

— CryoVascular Systems