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Lawrence A Garcia, Michael R Jaff, Krishna J Rocha-Singh, Thomas Zeller, Christopher Bosarge, Suraj Kamat, James F McKinsey
PURPOSE: To report a subset analysis that evaluated the hypothesis that directional atherectomy for peripheral artery disease in diabetic claudicants has noninferior primary patency at 12 months compared with nondiabetic claudicants. METHODS: DEFINITIVE LE, a US/European multicenter study, assessed the effectiveness of directional atherectomy using SilverHawk/TurboHawk systems for treatment of peripheral artery disease in the superficial femoral, popliteal, and infrapopliteal arteries...
October 2015: Journal of Endovascular Therapy
Keagan Werner-Gibbings, Steven Dubenec
BACKGROUND: Endovascular interventions are increasingly utilized in managing occlusive peripheral vascular disease. Angioplasty and stenting remain the mainstay of endovascular management; however, newer treatment modalities such as excisional atherectomy provide the clinician with additional treatment options. While demonstrating promising results in available trials, a paucity of data exist regarding peripheral atherectomy. The purpose of this retrospective clinical study was to assess the efficacy and safety of excisional atherectomy with the TurboHawk atherectomy device (Covidien/ev3, Plymouth, MN, USA) in the treatment of lower limb peripheral vascular disease and to evaluate the learning curve involved in the institution of a new treatment modality...
November 3, 2014: ANZ Journal of Surgery
James F McKinsey, Thomas Zeller, Krishna J Rocha-Singh, Michael R Jaff, Lawrence A Garcia
OBJECTIVES: The aim of this study was to assess the safety and effectiveness of directional atherectomy (DA) for endovascular treatment of peripheral arterial disease (PAD) in infrainguinal arteries in patients with claudication or critical limb ischemia. BACKGROUND: To date, no prospective, multicenter, independently-adjudicated study has evaluated the effectiveness and durability of DA in the treatment of PAD. Previous DA studies have not been prospectively powered to evaluate any differences in outcomes in patients with and without diabetes...
August 2014: JACC. Cardiovascular Interventions
David Roberts, Khusrow Niazi, William Miller, Prakash Krishnan, Roger Gammon, Theodore Schreiber, Nicolas W Shammas, Daniel Clair
OBJECTIVES: The purpose of the DEFINITIVE Ca(++) study was to evaluate the safety and effectiveness of directional atherectomy and distal embolic protection, used together to treat moderate to severely calcified femoropopliteal lesions. BACKGROUND: Despite advances in endovascular treatment modalities, treatment of calcified lesions remains a challenge. METHODS: A total of 133 subjects with 168 moderate to severely calcified lesions were enrolled...
August 1, 2014: Catheterization and Cardiovascular Interventions
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