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Non-Surgical Cryoplasty Therapy May Save Legs, Early Research Suggests
Non-Surgical Cryoplasty Therapy May Save Legs, Early Research Suggests -- Posted by Gumbo on 02-02-05 06:34
Non-Surgical Cryoplasty Therapy May Save Legs, Early Research Suggests
MIAMI BEACH, FL -- January 18, 2005 -- One-hundred percent of people facing
almost-certain amputation were successfully treated with a new non-surgical
therapy that gently cools and opens leg arteries clogged with plaque,
according to preliminary data on 22 patients being presented at the 17th
Annual International Symposium on Endovascular Therapy (ISET).
First available in August to treat patients with arteries that are blocked
below the knee, the new CryoPlasty therapy is now offered at nearly 800
sites in the United States, including most major hospitals.
CryoPlasty therapy offers hope to people with lower leg arteries that are
severely blocked as a result of peripheral arterial disease (PAD). 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.
PAD affects about 10 million people in the United States and 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 also can be used to treat other vessels affected by PAD,
including arteries in the thighs and abdomen.
"Previously, amputation was the only option for some people with such
advanced disease in arteries below the knee, many of whom are diabetic,"
said 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. "CryoPlasty is a 'no-harm'
treatment that offers early, conservative management and can be used
repeatedly -- not only avoiding or delaying amputation, but postponing the
use of more invasive procedures."
The data on 22 patients being presented at ISET by Dr. Joye are the first
results from Below the Knee Chill, an ongoing multi-center study at 30
leading hospitals across the United States, which will enroll 100 patients
who are likely facing amputation of a foot or leg within six months. All of
the patients in the study have critical limb ischemia, meaning they have
severely clogged leg arteries, causing extremely poor blood flow.
Treatment in all 22 patients (100 percent) patients resulted in procedural
success, meaning artery blockages (stenoses) were 50 percent or less after
CryoPlasty therapy. After treatment, the average blockage was 19 percent,
compared to 87 percent before treatment. Immediately after the procedure,
ankle or toe pulses improved in 17 of 20 patients (85 percent), meaning
blood flow increased. Pulses were not measured in two patients. There were
no procedural complications or adverse events. Follow-up is ongoing.
Other data, on 102 patients who received CryoPlasty therapy to treat blocked
upper leg or knee arteries, have shown:
83 percent of the arteries remained opened after nine months. Typically, 59
percent of blocked blood vessels treated with traditional angioplasty 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 very 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 -10º. 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 45 percent.
The below-the-knee CryoPlasty procedure is performed using one of several
new smaller sized catheters, which received clearance from the Food and Drug
Administration (FDA).
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 Dr.
Joye.
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 www.cryoinc.com,
www.cryoplasty.com or www.bostonscientific.com or call 1-877-456-LEGS.
SOURCE: CryoVascular Systems
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