Article preview reprinted from Medtech Insight - March 2010
The market for interventional devices designed to treat peripheral artery disease has long taken a backseat to the more high-profile interventional cardiology arena. However, with competitive and economic pressures now driving down prices and profits for coronary stents, manufacturers and investors alike are turning their attention to the still underpenetrated PAD opportunity, where device advancements are expanding the treatable patient population and could drive strong revenue growth in the years ahead. Read more...
The Next Wave in Peripheral Vascular Interventions
Article preview reprinted from Medtech Insight - March 2010
The market for interventional devices designed to treat peripheral artery disease (PAD) has long taken a backseat to the more high-profile interventional cardiology arena. However, with competitive and economic pressures now driving down prices and profits for coronary stents, manufacturers and investors alike are turning their attention to the still underpenetrated PAD opportunity, where device advancements are expanding the treatable patient population and could drive strong revenue growth in the years ahead. Although there are challenges to applying interventional tools and techniques to the peripheral vasculature, particularly in the lower extremities, this has been a very active research target for several years now and that effort is beginning to show significant upside potential.
Companies, both large and small, are now bolstering their PAD pipelines with products designed to improve the durability and safety of endovascular treatments in the lower extremities and reduce the need for surgery and limb amputation in patients with critical limb ischemia. The PAD arena still suffers from a lack of large, randomized studies comparing newer devices to well-established treatments like balloon angioplasty and bypass surgery, and there is no clear consensus about the superiority of one technology over another. Nevertheless, physicians and patients are increasingly embracing the endovascular approach to PAD treatment as a first-line therapy. At the same time, many challenges remain, leaving the door wide open for future product innovation, which will be the key to continued growth in this market.
Tackling the SFA
One area where physicians have encountered particular difficulty applying interventional techniques is in the superficial femoral artery (SFA) and popliteal arteries, which extend some 50 centimeters in length from mid-thigh to below the knee. Lower extremity PAD affects more than eight million people in the US and some 20% have disease significant enough to warrant intervention. Femoropopliteal sites account for approximately 60% of all diagnosed arterial occlusions in the lower extremities and more than half of all endovascular procedures are performed in the SFA.
There is also an unmet need for endovascular treatments in the distal tibial vessels, which run from mid-calf to the foot and are often affected in diabetic patients with poor vascular circulation. The most advanced cases present with lower-extremity arterial insufficiency and the absence of pedal pulse, claudication at rest, disuse atrophy, localized ischemic toe tissue necrosis, or nonhealing ulcers—all signals of critical limb ischemia (CLI), which affects some 5% of PAD patients and in the most severe cases necessitates limb amputation. Rates of major amputation have fallen over the past 20 years as surgical and interventional therapies improved; however, despite recent therapeutic advances, more than 220,000 limb amputations are still performed annually in the US and Europe, according to published estimates.
Although there has been significant recent progress in addressing lower limb PAD with endovascular techniques, the area is fraught with challenges. Disease in the femoropopliteal artery is frequently diffuse and calcified with a large, often eccentric plaque burden, making it difficult to treat effectively using standard balloon angioplasty and stenting techniques. Not only is restenosis an issue, but lesions in these vessels, particularly those in and around the knee, are also subjected to significant mechanical forces, including axial compression, extension, torsion, and bending forces that increase the risk of stent deformity and fracture, which is associated with poor long-term patency and other adverse outcomes.
As a result, a substantial number of patients are still treated with surgical fempop bypass, which remains the most commonly performed lower-extremity vascular reconstruction procedure and involves placement of a native or synthetic bypass graft from the common femoral artery to the popliteal artery. Some 200,000 femoropopliteal surgical bypass procedures are expected to be performed in the US alone this year. Although fempop bypass is associated with excellent long-term outcomes, with patency rates that average 75% at five years for native grafts and a 90% rate of limb salvage, the invasiveness of the procedure and the associated surgical risks are the driving forces behind the search for effective catheter-based alternatives.
That search has produced an endovascular toolbox that has swelled considerably over the past decade. A variety of catheter-based devices are now available for treating lower extremity PAD, ranging from new plaque debulking systems to a growing list of dedicated, self-expanding nitinol stents and advanced balloon technologies. These new tools have expanded the number and type of patients eligible for endovascular treatment, spurred an influx of interventional cardiologists and endovascular surgeons into the arena, and accelerated a still ongoing shift away from surgery toward the endovascular approach.
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Companies mentioned in this article:
Abbott Laboratories Inc.
Abbott Vascular Devices
AngioScore Inc.
Angioslide Ltd.
Angiotech Pharmaceuticals Inc.
Boston Scientific Corp.
CR Bard Inc.
Cardiovascular Systems Inc.
Cook Group Inc.
Cook Medical Inc.
Dartmouth-Hitchcock Medical Center
Edwards Lifesciences Corp.
Flexible Stenting Solutions Inc.
Johnson & Johnson
Cordis Corp.
Kensey Nash Corp.
NovoStent Corp.
Pathway Medical Technologies Inc.
Spectranetics Corp.
Terumo Corp.
University of California
University of California, Davis
WL Gore & Associates Inc.
YMed Inc.
ev3 Inc.
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