CryoVascular Systems, Inc. Release: Study Suggests Non-Surgical CryoPlasty(R) Therapy Promising Treatment For Blocked Leg Arteries

PHOENIX, Feb. 18 /PRNewswire/ -- An innovative new procedure that uses cooling therapy continues to show success in remedying difficult-to-treat blood vessel blockages, according to independent data presented by a Texas Heart Institute physician at the International Congress on Endovascular Intervention XVIII.

CryoPlasty therapy gently cools and opens arteries clogged with plaque due to peripheral arterial disease (PAD). PAD affects about 10 million people in the United States.

Many of the patients studied received CryoPlasty therapy after being treated with other methods and experiencing poor outcomes. The blockages that were treated occurred throughout the body, including the upper and lower legs, abdomen and upper body.

"Our early findings suggest the CryoPlasty technique is a simple, yet very effective therapy for treating a wide variety of PAD blockages," said Zvonimir Krajcer, M.D., program director for the peripheral vascular program at Texas Heart Institute and St. Luke's Episcopal Hospital, Houston. "We had very good success treating the blockages with CryoPlasty therapy alone."

In the single-center study, 51 people received CryoPlasty therapy for 64 blockages, the majority in the thighs, abdomen or lower legs and follow up ranged from three months to one year. After CryoPlasty therapy, only 2 of the blockages (3 percent) required placement of a stent. Placement of a stent after traditional angioplasty has been reported as high as 80 percent and a majority of the time multiple stents are required. Fifty-three percent of the patients had critical limb ischemia (CLI), meaning their lower leg arteries were so severely blocked, that they suffered pain in their legs and were at risk of amputation of a foot or leg. To date none of the patients have required amputation. Thirteen (48 percent) of the CLI patients have been followed for six months, and 11 (86 percent) say their leg pain has improved dramatically.

"This was quite dramatic, because these are the most difficult types of patients to treat," said Dr. Krajcer, who also is a clinical professor of medicine at both Baylor University and University of Texas Health Science Center, Houston.

After CryoPlasty therapy, the overall rate of dissection -- a split in the arterial wall that is common in conventional angioplasty -- was only 8 percent. This compares favorably to the dissection rate for angioplasty which ranges from 40-70 percent.

PAD is a strong risk factor for other cardiovascular diseases, including heart attack or stroke. CryoPlasty therapy fits into the treatment spectrum before the use of angioplasty and appears to avoid some of the complications seen in that procedure. It can be used to treat blocked blood vessels affected by PAD, including arteries in the thighs, abdomen and below the knees.

CryoPlasty therapy offers hope to people with severely blocked below-the- knee arteries. These blockages, which are particularly common in diabetics, can reduce blood flow to the legs and feet, putting people at risk for infection, leg ulcers, gangrene and amputation.

Previously reported data on 102 patients who received CryoPlasty therapy to treat blocked upper leg arteries, have shown:

-- 83 percent of the arteries remained opened after nine months. Typically, an estimated 60 percent of blocked blood vessels treated with traditional angioplasty and/or stenting remain open after one year. -- 89 percent of people reported an improvement in leg pain while walking.

In traditional angioplasty, a catheter is used to advance a tiny balloon to the site of the blockage. The balloon is then filled with saline, compressing the walls of the clogged artery to open it and allow blood flow. Angioplasty is minimally invasive and initially works well, but it causes scarring of the artery wall that can prompt the artery to close.

CryoPlasty therapy involves the use of nitrous oxide, rather than saline, to inflate the balloon and cool it to -10 degrees C. This in turn prompts several physical responses that open the artery and cause less scarring than occurs with traditional angioplasty. Repeat procedures for patients treated with standard balloon angioplasty and stent technology of the arteries below the knee are reported to be as high as 85 percent.

The CryoPlasty procedure is performed using one of several new smaller sized catheters. Physicians who perform angioplasty are capable of performing CryoPlasty therapy, including vascular surgeons, interventional cardiologists and interventional radiologists.

"While this is a relatively new technology, the process is very familiar to physicians who perform angioplasty and its use is rapidly spreading in hospitals across the country," according to James D. Joye, D.O., director of the Cardiac Catheterization Lab at El Camino Hospital, Mountain View, Calif., and co-inventor of the CryoPlasty technique.

The PolarCath System is a proprietary technology for delivering the CryoPlasty therapy developed by CryoVascular Systems, Inc., a privately held Silicon Valley company that is focusing on state-of-the-art interventional therapy for the treatment of vascular disease. CryoVascular Systems has a strategic partnership with Boston Scientific Corporation (BSX), a long- standing leader in vascular disease technology, to distribute the PolarCath System globally. For more information, log onto or .

Physicians and patients can receive a free information packet on PAD and CryoPlasty by calling 1-877-456-LEGS or visiting .

Editor's Note: Press materials including news releases, images and animation are available online at .

AT A GLANCE -- CryoPlasty therapy is showing promise in treating advanced disease of arteries, according to an independent, single-site study. -- CryoPlasty therapy treats arteries below the knee, in the thighs and in the abdomen that become blocked due to peripheral arterial disease (PAD). -- PAD affects about 10 million people in the United States. -- For more information, visit or call 1-877-456-LEGS.

CryoVascular Systems, Inc.

CONTACT: Teresa Luepke of PCI for CryoVascular Systems, Inc.,+1-312-558-1770,

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