CLINICAL OUTCOMES TurboHawk 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 TurboHawk™ and SilverHawk™ directional atherectomy devices 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:


Downloads

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

pdf DEFINITIVE LE 12 Month Prospective Results (.pdf)

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

130KB

pdf DEFINITIVE LE 12 Month Infrapopliteal Results (.pdf)

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

130KB

pdf DEFINITIVE LE 12 Month Claudicant Diabetic Results (.pdf)

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.

158KB