Peripheral Arterial Disease Represents a Significant and Rapidly Growing Market Opportunity for Interventional Therapies, Particularly Endovascular Technologies

----Endovascular intervention, employing minimally invasive, catheter-based technologies, is expected to become the dominant therapeutic modality for atherosclerotic diseases in the lower limbs, according to a new report published by THE SAGE GROUP (click here for the report).

"Already the preferred initial interventional therapy for most types of lesions in aortoiliac disease, endovascular intervention is rapidly becoming the initial therapy for many types of femoropopliteal disease," stated Mary L. Yost, President of THE SAGE GROUP.

"Development of new technologies, especially for the treatment of superficial femoral artery (SFA) disease, total occlusions, diffuse disease, critical limb ischemia and tibioperoneal disease is contributing to the shift to less invasive treatment," continued Yost.

"Despite our enthusia for endovascular therapies in general, we are not optimistic about the potential for the current bare metal, or drug-eluting stent platforms in the SFA," stated Yost. "In addition to the challenging anatomy and the prevalence of long total occlusions, stents in this region must endure a number of unique mechanical forces."

"Stent fracture and migration have already been reported with SFA-implanted nitinol stents raising questions regarding clinical consequences and longer-term patency. Additional studies are underway. We believe that current nitinol stent platforms are likely to prove inadequate in treating SFA disease," concluded Yost.

Although the peripheral interventional market is moving to minimally invasive therapies, bypass surgery remains the gold standard. According to Yost, "Growth in the number of bypass procedures should outpace demographic trends due to increasing diagnosis and treatment of PAD, the trend to multiple interventions over a patient's lifetime, greater awareness of two-limb disease and substitution for amputation."

The current interventional market is estimated at 920,000 procedures. "Because PAD has been woefully underdiagnosed and inadequately treated, this represents only a fraction of the potential. If all patients are diagnosed and receive appropriate treatment, the market exceeds 6 million procedures," contends Yost.

"Intensification of public education and screening programs coupled with greater training of primary care providers is expected to lead to a substantial increase in the percentage of patients diagnosed, and treated. By 2010 the percentage of PAD patients diagnosed could reach 30%-35%, which represents an interventional market of 2.2 to 2.5 million procedures," concluded Yost.

About the Peripheral Arterial Disease Research Study

The four-volume PAD 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 all involved in cardiovascular therapeutics with a comprehensive analysis of the disease, prevalence, current treatments, new technologies and company participants.

Volume I: Peripheral arterial disease (PAD) - prevalence, current treatments & new technologies published in 2003, offers a unique insight into the under-diagnosis of PAD and the therapeutic opportunities available when the condition is identified. The report provides a detailed analysis of sales of cardiovascular therapeutics and how these figures could change with improved disease awareness. The report concludes that the market value of anti-hypertensives could be doubled; that claudication drugs could increase by as much as 6-fold; and the already $13 billion market for lipid lowering agents could double. Perhaps most dramatic is the estimated impact of improved PAD management on the sales of anti-platelet agents and in particular Plavix, the annual US sales of which are estimated as being able to increase by 10-fold. Having determined the size of these potential markets figures are then projected to 2005, 2010, 2015 and 2020 to reflect the impact of increased PAD prevalence.

Volume II: Peripheral arterial disease (PAD) - A Significant for Interventional Therapies analyzes the peripheral interventional market in the aortoiliac, femoropopliteal and tibial vessels. It provides an in-depth discussion of 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. The interventional, bypass and endovascular markets are estimated based on epidemiology and demographics. Market potential is calculated by disease severity in terms of patients, limbs and primary and revision procedures. Specific estimates are made for 2000, 2003 and selected years through 2020.

Two further reports are currently being completed focusing on new pharmaceutical and interventional therapies

About THE SAGE GROUP

THE SAGE GROUP is an independent research and consulting company offering clients a unique disease-based approach to investing in the pharmaceutical, medical device and biotechnology industries.