Amputations are not only disfiguring and life-threatening, but are more dangerous and more expensive than revascularization, which is the reestablishment of blood supply. Diabetics are especially at risk for non-traumatic amputations, accounting for 82,000 non-traumatic lower extremity amputations (LEAs) in the U.S. yearly, according to the American Diabetes Association. The Centers for Disease Control (CDC) reports more than 60 percent of LEAs occur in diabetics.
These statistics are telling, and have one of the country's leading clinical investigators and cardiologists astounded. "It is shocking that in this day and age, there is an epidemic of unnecessary amputations. Amputation is a drastic procedure that takes a great physical and emotional toll on patients and their families. But physicians often jump too quickly to amputation rather than exploring medical advances that can prevent limb loss," said Dr. Craig Walker, of the Cardiovascular Institute of the South, in Houma, La.
Walker is a pioneer in a medical procedure to combat these trends: Cool Laser Revascularization for Peripheral Artery Therapy, or "CLiRpath."
"In the U.S. alone, there are approximately 1.8 million people living with limb loss," Walker said, citing National Limb Loss Amputation Center statistics. "A good portion of these individuals could have salvaged their limbs. This is tragic." Of note:
--The number of diabetes-related LEA hospital discharges increased by 240 percent between 1980 (33,000) to 2002 (82,000), according to the CDC. --The CDC says the five-year survival rate for all lower extremity amputees is less than 50 percent. For diabetic amputees, the rate is less than 40 percent. --In a five-year study in medical journal Diabetes Care, 40 percent of diabetics and 29.8 percent of non-diabetics had a second amputation to the same or opposite limb at an average of 16.2 and 12.3 months, respectively, after the first amputation.
In advanced stages of peripheral vascular disease (PVD), common in diabetics, plaque blocks arteries, resulting in rest pain, development of foot ulcers and onset of limb loss. The CLiRpath procedure, using a "cool" excimer laser and catheter system developed by Spectranetics Corp. (NASDAQ: SPNC), vaporizes arterial blockages, restores blood flow, and this surgery promotes wound healing, often enabling patients to leave the hospital the next day. CLiRpath has been the subject of rigorous clinical trials, with limb salvage observed in 95 percent of patients surviving to six months(1). The procedure is now available in more than 300 hospitals across the U.S.
Amputation decisions greatly impact lives of many people, like Michael Sevante, of Houma, La. In 2002, Sevante had recurring leg cramps and was diagnosed with PVD. He developed a non-healing infection and underwent an amputation below his left knee. As a result, Sevante had to walk his daughter down the aisle on her wedding day with a walker and a prosthetic limb.
Six months after his first amputation, he experienced similar symptoms in his right leg and decided to aggressively pursue amputation alternatives to avoid having to live in a wheelchair. He was referred to Dr. Walker, who was able to save Sevante's leg with CLiRpath. Today, Sevante is virtually pain free.
"After my first amputation, I would have done anything to avoid a second," said Sevante. "Had I not asked for an alternative, I fear I was on track for the loss of another limb. This would have meant the beginning of the end for me."
About Spectranetics Corp.
For more information about CLiRpath, visit www.clirpath.com. Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. Its CVX-300(R) excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy, and the removal of problematic pacemaker and defibrillator leads. Nearly all of our FDA-approved and investigational applications have received Communautes Europeennes (CE) mark registration for marketing within Europe. In April 2004, the Company obtained 510(k) clearance from the FDA for the laser-based treatment of patients suffering from total occlusions (blockages) in their leg arteries that are not crossable with a guidewire. For more information, visit www.spectranetics.com.
(1) Limb salvage for patients surviving to six months (40/42) in LACI CTRO Registry. Limb salvage by intent to treat analysis at six months was 85 percent (40/47 patients).
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