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Summary of NICE guidance
  1. Sebastian Sixt,
  2. Thomas Zeller
  1. Department of Angiology, Heart Centre Bad Krozingen, Germany
  1. Correspondence to Dr Sebastian Sixt, Herz-Zentrum Bad Krozingen, Südring 15, D-79189 Bad Krozingen, Germany; sebastian.sixt{at}

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The limitations of the first directional atherectomy (DA) device introduced in the '80s1 have mostly been overcome by the second-generation SilverHawk (Ev3, Plymouth, Minnesota, USA) device. First of all, this device is easier to use with no further need for concomitant balloon inflation. The newer generation of the DA SilverHawk devices also has a modified assembly and cutting technique and has clearly demonstrated its technical safety and efficiency in single-centre and also in multi-centre performance, clearly overcoming the initial technical limitations. The overall risk of peripheral macro-embolisation is, under angiographic control, around 1.5% without leaving major damage at the end of the procedure. Related to the broad clinical experience gathered over more than 1 decade, DA warrants no more detailed patient information than on the already well-established routine bases. This holds true for trained physicians, who feel confident with the device after some initial experience. The intraluminal plaque burden can be removed through directional cutting even in long and concentric lesions. Initial promising single-centre and two multi-centre reports with high acute technical and clinical success rates and acceptable longer-term patency rates for femoro-popliteal and below-the-knee lesions resulted in a widespread use of the technology.2–5 Even calcified lesions can nowadays be treated highly effectively with the newer-generation TurboHawk device (Ev3), which contains some technical changes in the cutter blade design (four-angled cutter blades to better engage in heavily calcified lesions), in the jog that controls the apposition force for consistent directional cutting of the plaque across a variety of vessel diameter and, finally, in the drive shaft with better power transmission to the cutting blade. Routine use of a distal protection device in calcified lesions is recommended. More technical and clinical data will soon be generated in the first prospective multi-centre clinical trial, the Definitive LE Study (Determination of …

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  • Competing interests None to declare.

  • Provenance and peer review Commissioned; externally peer reviewed.