The SilverHawk™ Peripheral Plaque Excision System, manufactured by Medtronic, is a directional atherectomy device used to treat Peripheral Arterial Disease (PAD) by physically removing plaque from blocked arteries.
Clinical Indications & Success
- Target Areas: Intended for the peripheral vasculature, including vessels above and below the knee. It is not for use in coronary, carotid, iliac, or renal arteries.
- Clinical Outcomes: The landmark DEFINITIVE LE clinical study showed a 95% limb salvage rate at 12 months for patients with critical limb ischemia.
- Plaque Type: Primarily effective for soft-to-mild plaque; more advanced versions like the TurboHawk™ or HawkOne™ are often used for moderate to severe calcification.
Manufacturer: Medtronic plc.
Addresses:
- Primary Headquarters
- Operational Headquarters (United States):
- Address: 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA.
- Function: Serves as the main hub for global operations, including engineering, executive leadership, and sales.
- Global Corporate Headquarters (Ireland):
- Principal Executive Office: Building 2, Parkmore Business Park West, Co. Galway, H91 4K49, Ireland.
- Registered Office: 20 Hatch Street Lower, Dublin 2, D02 XH02, Ireland.
Product Prices
As of 2025, the pricing for the SilverHawk™ Peripheral Plaque Excision System varies significantly based on the purchasing entity (e.g., hospital, surgical center, or international distributor) and the specific model configuration.
Unit Device Pricing
For individual catheters and systems, prices listed by medical suppliers in late 2024 and 2025 include:
- Retail/Individual Unit: Approximately $11,791.99 USD per catheter (e.g., for the SilverHawk EXL model, 6F compatibility) when purchased through third-party medical supply vendors.
- Marketplace/Secondary Listings: Used or “in-date” surplus units can range from $1,384.99 to $2,318.00 depending on the specific product code and sterilization status.
- Alternative Systems: Similar Medtronic directional atherectomy systems, such as the HawkOne™, are listed at roughly $7,190.00 for new units.
Total Procedure Costs
The cost of an atherectomy procedure using a SilverHawk device includes not only the device itself but also hospital fees, physician fees, and potential supplemental equipment (like embolic protection filters).
- United States Average: Atypical atherectomy procedures generally cost between $15,000 and $35,000 in total.
- International Pricing: Minimum procedure costs are lower in other regions, with India estimated at $6,000 to $7,000 and Turkey starting from $6,500.
Free References
Plaque Excision in Management of Lower Extremity Peripheral Arterial Disease with the SilverHawk Atherectomy Catheter
First-in-Man Study of a Novel Peripheral Plaque Atherectomy Device
Plaque excision with the Silverhawk catheter: Early results in patients with claudication or critical limb ischemia
Plaque Excision Treatment of Infrainguinal PAD
Early Experience With a Novel Plaque Excision System for the Treatment of Complex Coronary Lesions
Published Evidence on Peripheral Atherectomy: A Meta-analysis and Systematic Literature Review of More Than 300 Original Investigations
A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions: The SELUTION SFA Japan Trial
Directional Atherectomy for Critical Lower Limb Ischemia: A Retrospective Observational Study
A Retrospective Comparative Study of Mid-Term Outcomes of Atherectomy, Drug-Coating Balloon Angioplasty, and Plain Old Balloon Angioplasty for Isolated Atherosclerotic Popliteal Artery Lesions
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