Cordis has announced the launch of the Powerflex Pro .035” percutaneous transluminal angioplasty (PTA) dilatation catheter in Europe for the treatment of peripheral vascular disease in the lower extremities.
This balloon catheter offers many features and benefits to aid in patient treatment; including long lengths up to 220mm to treat long lesions in one uniform dilatation, short balloon shoulders for accuracy and post-dilatation ballooning, along with a rated burst pressure of up to 18 atmospheres to treat calcified lesions.
It is estimated that approximately 27 million people in Western Europe and North America have peripheral vascular disease (1-2). The 5 year rate of non-fatal cardiovascular events (including MI and stroke) among patients with symptomatic peripheral artery disease is ~ 20%, with mortality ranging from 15-30% (3-4). Of the 1-2% of patients who develop critical limb ischaemia, up to 25% may ultimately require amputation and annual mortality in these patients may be as high as one in four (5). For those patients presenting with more advanced disease such as acute limb ischaemia, critical limb ischaemia or severely limiting symptoms, revascularisation may be necessary with many guidelines now recommending an endovascular first approach (6-7).
References:
1. Belch JJ, Topol EJ, Agnelli G, Bertrand M, Califf RM, Clement DL et al. Critical issues in peripheral arterial disease detection and management: a call to action. Arch Intern Med 2003 April 28;163(8):884-92.
2. Lau JF, Weinberg MD, Olin JW. Peripheral artery disease. Part 1: clinical evaluation and noninvasive diagnosis. Nat Rev Cardiol 2011 July;8(7):405-18.
3. Weitz JI, Byrne J, Clagett GP, Farkouh ME, Porter JM, Sackett DL et al. Diagnosis and treatment of chronic arterial insufficiency of the lower extremities: a critical review. Circulation 1996 December 1;94(11):3026-49.
4. 2011 ACCF/AHA Focused Update of the Guideline for the Management of patients with peripheral artery disease (Updating the 2005 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2011 November 1;124(18):2020-45.
5. O’Hare AM, Glidden DV, Fox CS, Hsu CY. High prevalence of peripheral arterial disease in persons with renal insufficiency: results from the National Health and Nutrition Examination Survey 1999-2000. Circulation 2004 January 27;109(3):320-3.
6. Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clement D, Collet JP et al. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J 2011 November;32(22):2851-906.
7. Lammer J. The Inter-Society consensus (TASC IIb) Peripheral Artery Disease Guidelines Update:Revision of the TASC Lesion Classification and Recommendations for Revascularization. Oral presentation CIRSE Munich, 2011.
