The Sage Group

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

ATLANTA, August 25, 2004–(BUSINESS WIRE)–Endovascular, 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.

“Already the preferred initial interventional therapy for most types of lesions in aortoiliac disease, endovascular 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 enthusiasm 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.

Peripheral Arterial Disease Volume II

Volume II of the Peripheral Arterial Disease Research Study 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.

Published peer-reviewed medical research and medical society presentations are the primary information resources. All sources are cited; Volume II contains almost 300 references.

Public companies included in this report: Abbott Laboratories (ABT), AngioDynamics (ANGO), Boston Scientific (BSX), Bristol-Myers Squibb (BMY), Bard (BCR), CryoLife (CRY), Datascope (DSCP), Edwards Lifesciences (EW), Guidant (GDT), Johnson & Johnson (JNJ), Medtronic (MDT), Possis Medical (POSS), Regeneration Technologies (RTIX), Roche Holding (RHHBY), Sanofi-Synthelabo (SNY), Spectranetics (SPNC), Synovis Life Technologies (SYNO) and Terumo Corporation (JP: 4543).

Private companies include: Atrium Medical Corporation, Boehringer Ingelheim, Cook Group, CryoVascular Systems, ev3, Inc., FoxHollow Technologies, IntraLuminal Therapeutics, LeMaitre Vascular, LuMend, Orbus Medical Technologies, Vascular Architects, Volcano Therapeutics and W.L. Gore.

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 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 of the first volume is the U.S. market potential for currently marketed pharmaceuticals employed to treat hypertension, adverse lipid profiles, platelet aggregation and claudication.

Information and financial data is included for 26 companies.
New pharmaceutical and interventional therapies are the focus of Volume III and IV with the preliminary list of companies exceeding 70.


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).

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