Healthcare Professionals

SilverHawk Peripheral Plaque Excision System

Atherectomy of Peripheral Vasculature

  • SilverHawk Plaque Excision System

Overview

Preserve the native vessel and keep future treatment options open for PAD patients when you treat with the SilverHawk™ peripheral plaque excision system. Use the device's directional cutter to shave soft-to-mild plaque, while the nosecone captures the material for removal from the artery. The SilverHawk technology is backed by the landmark DEFINITIVE LE clinical study, which found that PAD patients with critical limb ischemia who were treated with plaque excision experienced a high rate (95%) of limb salvage at 12 months.1

U.S. Indications

The SilverHawk™ Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The catheter is NOT intended for use in the coronary, carotid, iliac or renal vasculature.

Product Details

The SilverHawk peripheral plaque excision system treats peripheral arterial disease (PAD) by removing plaque from blocked arteries. Unlike other methods of restoring blood flow, the SilverHawk device removes the obstruction—plaque build-up—instead of simply compressing it against the vessel wall. Directional atherectomy with the SilverHawk device enables physicians to maximize lumen gain and minimize barotrauma without leaving any implant behind. This allows preservation of the native vessel and future treatment options.

  • Treats peripheral arterial disease by removing the disease with directional atherectomy technology.
  • Uses a directional cutting blade to shave plaque from the vessel to maximize luminal gain.
  • Captures plaque in a nosecone so that the plaque can be removed from the vessel.
  • Can be used above or below the knee.
  • Backed by the landmark DEFINITIVE LE clinical study.
SilverHawk nosecone

Manuals and Technical Guides

Instructions for Use
Find this technical manual in the product labeling supplied with each device or by calling technical support for cardiovascular devices: +1 763-526-7890.

Model Specifications

 
Model Name LX-M MS-M SS+ EXL DS
Reference Number P4055 P4056 P4030 P4044 P4028
Vessel
Diameter (mm)		 4.5-6.5 3.5-5.0 3.0-3.5 2.0-3.0 1.5-2.0
Sheath
Compatibility* (F)		 7 / 8 7 / 8 7 6 6
Crossing
Profile (mm)		 2.7 2.7 2.3 2.0 1.9
Working
Length† (cm)		 113 110 135 135 135
Effective
Length** (cm)		 104 104 132 129 132
Tip Length (cm) 9.0 6.0 2.6 6.0 2.6
Max. Cut
Length (mm)		 75 50 15 15 10
Packing Device X X   X  

*Sheath Compatibility - Per the Instructions For Use, the medium vessel and large vessel devices are compatible with 8 F sheaths. A physician survey of device usage indicated 7 F sheaths may have an Internal Diameter (ID) that will accommodate the crossing profile of the LX-M, LS-M, and MS-M (non-flush tip) devices. Data on file with manufacturer.

†Working Length - distal end of strain relief to the distal end of tip.

**Effective Length - distal end of strain relief to the proximal end of cutter window.

 

Max guidewire is 0.014” for all SilverHawk devices.

See product catalog for complete, detailed product information.

1

McKinsey et al. JACC: Aug 2014;7;8;923-33