Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)

Determination of Safety and Effectiveness of the SilverHawk™ Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX™ Embolic Protection Device for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++)

This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in treatment of moderate to severely calcified peripheral arterial disease in the superficial femoral and/or popliteal arteries.

Inclusion Criteria:

• Provides written informed consent
• Willing to comply with follow-up evaluations at specified times
• Has leg pain due to peripheral arterial disease
• Disease located within the femoropopliteal artery
• Moderate to severe calcification

Exclusion Criteria:

• Previously implanted stent(s) or stent graft(s) in target leg
• Life expectancy less than 12 months
• Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure