WASHINGTON, Sept. 30 /PRNewswire/ -- People suffering from critical limb ischemia have an encouraging new alternative to below-the-knee amputation in the minimally invasive CryoPlasty(R) procedure, suggests research presented today at the Cardiovascular Research Foundation’s Sixteenth Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium (TCT 2004) in Washington, D.C.
Outcomes of the first patients to receive the therapy revealed 95 percent of the patients were able to avoid almost-certain amputation below the knee as a result of treatment with the PolarCath(TM) System Infrapopliteal Catheter, which uses the CryoPlasty technique to gently cool and revascularize atherosclerotic arteries.
“Patients with this type of advanced disease -- many of whom are diabetic -- have very few treatment options,” said James Joye, D.O., director of the Cardiac Catheterization Lab at El Camino Hospital, Mountain View, Calif., and co-founder of the CryoPlasty technique. “The CryoPlasty procedure is a conservative ‘no harm’ therapy that can be employed early in the disease process, and can be repeated if necessary without hindering future treatment options. It may be possible to delay progression of the disease to the limb threatening stage.”
Critical limb ischemia is the later stage of peripheral arterial disease (PAD), also known as peripheral vascular disease (PVD), or clogged arteries in the arms and particularly the legs. Patients with critical limb ischemia are at risk for ulceration, infection, gangrene or amputation. Approximately 160,000 amputations are performed every year in the United States as a result of this condition, according to The Sage Group, an independent research firm. This number is expected to grow as the population ages and diabetes incidence increases.
PolarCath is a new vascular device that treats clogged arteries by cooling them to -10 degrees Celsius/+14 degrees Fahrenheit with a balloon filled with liquid nitrous oxide. This gentle cooling of the plaque and artery wall results in three potential beneficial effects: weakening the plaque promoting universal dilation and less vessel trauma, reducing vessel wall recoil and inducing apoptosis (natural cell death in the smooth muscle cells that are implicated in restenosis). The combination of these effects appears to minimize some of the complications that ultimately contribute to the reclogging of the vessels.
Outcomes of the first patients treated with CryoPlasty are being reported at TCT: 26 lesions in arteries below the knee were treated in 20 patients who had leg pain at rest or ischemic ulceration and gangrene. All 20 patients received the CryoPlasty technique using the PolarCath System Infrapopliteal Catheter as the primary therapy; 6 patients with severely blocked vessels underwent atherectomy to create a channel that would allow passage of the catheter. Limb salvage with freedom from major amputation was achieved in 19 patients (95 percent) and only 1 patient (5 percent) proceeded to below-the-knee amputation. Five patients (25 percent) underwent toe or transmetatarsal amputation of pre-existing gangrene and 1 patient who was treated for bilateral disease underwent subsequent bypass surgery in one limb.
“Once it is established that lifestyle changes and drug therapy aren’t working for these people, the CryoPlasty technique is a reasonable first-line interventional option, even before standard angioplasty,” said Dr. Joye. “It appears to avoid some of the potential complications that occur in traditional angioplasty, such as dissection and restenosis.”
In February 2004 the Food and Drug Administration (FDA) cleared the PolarCath System Infrapopliteal Catheter for treatment of atherosclerotic lesions in the infrapopliteal and tibioperoneal arteries (below the knee). The procedure is already available at approximately 100 hospitals, and will be available at approximately 600 major hospitals across the country by the end of this year.
Enrollment began in September 2004 for Below the Knee Chill, an ongoing multi-center limb salvage study at 30 leading hospitals across the United States. Preliminary study results will be presented in early 2005.
The incidence of PAD is on the rise. Researchers estimate about 10 million people in the United States suffer from PAD, yet only 25 percent of PAD patients are receiving treatment. Symptoms of PAD include painful cramping in the legs or hips when walking or exercising, numbness, tingling or weakness in the leg, and cold legs or feet. In severe cases, patients experience pain in the feet or toes even at rest and may develop ulcerations, infection or gangrene, particularly below the knee.
The PolarCath System is a proprietary technology developed by CryoVascular Systems, Inc., a privately held Silicon Valley start-up 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, visit log onto http://www.cryoinc.com/ or http://www.bostonscientific.com/ .
AT A GLANCE -- The minimally invasive CryoPlasty procedure using the PolarCath System Infrapopliteal Catheter was highly successful in helping people with severe peripheral arterial disease (PAD) avoid amputation. -- 95 percent of the first patients treated with the procedure were able to avoid near-certain below-the-knee amputation. -- Using CryoPlasty, the PolarCath System gently cools and revascularizes the clogged arteries, and helps prevent reclogging. -- CryoPlasty therapy is a ''no harm’’ treatment that can be repeated without eliminating future treatment options.
CryoVascular Systems, Inc.
CONTACT: Teresa Luepke of PCI, +1-312-558-1770
