Peripheral Arterial Disease (PAD)-Related Amputations Cost an Estimated $10 Billion, According to THE SAGE GROUP

Atlanta, September 9, 2004–(Business Wire)–According to a report published by THE SAGE GROUP (www.thesagegroup.us), approximately 160,000 amputations are performed annually in the U.S. because of PAD. Depending on the patient population, procedural mortality rates range from 4%-30% and morbidity from 20%-37%.

“Amputation is not only extremely undesirable from the patient’s viewpoint, it is socially undesirable in terms of costs,” stated Mary L. Yost, author of the report. “The inability of a large percentage of these amputees to live independently adds significantly to the total cost burden.”

Only 40% of those undergoing a below-the-knee operation, and 20% or less of those undergoing above-the-knee amputation achieve full mobility.

PAD is characterized by a reduction of blood flow to the lower limbs due to atherosclerosis, commonly called hardening of the arteries. Atherosclerosis is a disease in which the walls of the arteries thicken and harden as a result of the build-up of fatty deposits (plaque) on their inner lining.

In the later stages of PAD (critical limb ischemia or CLI) blood flow is so inadequate that ulcerations and gangrene occur. Once PAD has progressed to CLI, the risks of limb loss and mortality increase. At six months approximately 20% of those with CLI will die; another 35% will experience amputation.

“CLI is in effect ‘end-stage’ PAD,” explained Yost. Many therapeutic options are available that can slow or even prevent disease progression to the critical stage.” Initial treatment includes cessation of smoking, dietary changes and drug therapies to reduce cholesterol and high blood pressure, and if the patient has diabetes, glucose control.

“If the disease has progressed to the ischemic stages, several minimally invasive therapies are available, as well as surgical bypass,” stated Yost. “Advances in the basic knowledge of the atherosclerotic process in the lower limbs and an improved understanding of peripheral disease are fueling a wave of technological innovation. A number of promising new treatments have been approved by the FDA and others are in clinical trials,” Yost elaborated.

According to THE SAGE GROUP, a 25% reduction in the number of amputations could save an estimated $2.9 billion in health care expenditures.

“Early identification and treatment of the disease is the key factor in preventing PAD-related amputations, as well as death from heart attack and stroke. Although an inexpensive, noninvasive diagnostic test, the Ankle-Brachial Index (ABI), is available, the majority of PAD patients remain undiagnosed. Even when diagnosed, many of these patients are inadequately treated,” declared Ms. Yost.

“Fortunately, this is rapidly changing. Numerous catalysts have converged that are expected to result in recognition of PAD as a major and growing health and economic problem, as well as an important market opportunity for pharmaceutical and medical device companies,” stated Yost.

These include ongoing education, awareness and screening programs such as those sponsored by Legs for Life(R), the American Vascular Association (AVA) and the Vascular Disease Foundation (VDF). “Of major importance,” declared Yost “is the recent formation of the National PAD Coalition, a unique coalition of 15 major public health organizations and professional vascular societies.” In addition to coordinating clinician educational efforts, the top priority of the Coalition is to create a unified, long-term national awareness campaign about PAD.

Patient Information

September is National PAD Awareness Month with free screenings offered in hospitals, clinics and senior centers. For more information visit http://www.legsforlife.org/ or http://www.vdf.org/. The AVA also offers a screening program, which in 2004, was held in May. Additional information can be found by clicking the AVA link at http://www.vascularweb.org/.

The PAD Research Study

The four-volume Peripheral Arterial Disease Research Study focuses on lower extremity peripheral arterial disease, or disease located in, or below the lower aorta and the iliac arteries. The PAD Study provides institutional money managers and industry executives with a comprehensive analysis of the disease, prevalence, current treatments, new technologies and company participants.

Volume I published in 2003, analyzed the disease, symptoms and consequences and risk factors associated with atherosclerosis in the lower extremities. The investment focus is the U.S. market potential for currently marketed pharmaceuticals.

Volume II published in 2004 analyzes the peripheral interventional market. Surgical bypass and grafts, angioplasty, stents, stent-grafts and other FDA-approved endovascular therapies, including atherectomy, cryoplasty, the excimer laser, the cutting balloon and new devices to cross total occlusions are discussed in detail. The investment focus is the market potential for surgical bypass and endovascular therapies.

Pharmaceutical and interventional therapies in research are the focus of Volume III and IV.

About THE SAGE GROUP

THE SAGE GROUP, an independent research and consulting company, specializes in atherosclerotic disease in the lower limbs, specifically PAD (Peripheral Arterial Disease), CLI (Critical Limb Ischemia) and ALI (Acute Limb Ischemia).

For additional information visit www.thesagegroup.us.

SOURCE: THE SAGE GROUP