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CLINICAL OUTCOMES SilverHawk™ Peripheral Plaque Excision System

DEFINITIVE LE Clinical Summary

The DEFINITIVE LE study is one of the largest multinational, multicenter PAD device studies to date, enrolling 800 patients from 47 sites in the United States and Europe. It provides insight into the clinical utility of directional atherectomy with the SilverHawk™ Directional Atherectomy Device in a broad range of patients, including diabetics, non-diabetics, claudicants, and those with critical limb ischemia (CLI).

Read more about the DEFINITIVE LE clinical study in published, peer-reviewed journals:

DEFINITIVE LE - acute
Acute Results of Directional Atherectomy for the Treatment of Claudication and Critical Limb Ischemia in the DEFINITIVE LE Study(opens new window)

DEFINITIVE LE - primary
Lower Extremity Revascularization Using Directional Atherectomy: 12-month Prospective Results of the DEFINITIVE LE Study(opens new window)

DEFINITIVE LE - infrapopliteal
One-year Outcomes Following Directional Atherectomy of Infrapopliteal Artery Lesions: Subgroup Results of the Prospective, Multicenter DEFINITIVE LE Trial(opens new window)

DEFINITIVE LE - diabetes
A Comparison of Clinical Outcomes for Diabetic and Nondiabetic Patients Following Directional Atherectomy in the DEFINITIVE LE Claudicant Cohort(opens new window)

DEFINITIVE Calcium
Effective Endovascular Treatment of Calcified Femoropopliteal Disease with Directional Atherectomy and Distal Embolic Protection: Final Results of the DEFINITIVE Ca⁺⁺ Trial(opens new window)

Downloads

Download these clinical paper reviews and learn more about DEFINITIVE LE results overall.

pdf DEFINITIVE LE 12-Month Prospective Results (.pdf) (opens new window)

Highlights from study to evaluate safety and effectiveness of directional atherectomy for treatment of peripheral arterial disease.

127KB

Document thumbnail (opens new window)
pdf DEFINITIVE LE 12-Month Infrapopliteal Results (.pdf) (opens new window)

Highlights from study to evaluate effectiveness of directional atherectomy for treatment of peripheral arterial disease in infrapopliteal lesions at one year.

133KB

Document thumbnail (opens new window)
pdf DEFINITIVE LE 12-Month Claudicant Diabetic Results (.pdf) (opens new window)

Highlights from DEFINITIVE LE subset analysis evaluating hypothesis that directional atherectomy for treatment of peripheral arterial disease in claudicants with diabetes has non-inferior primary patency at one year compared with claudicants without diabetes.

142KB

Document thumbnail (opens new window)

See product catalog for complete, detailed product information. 

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