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Stealth 360™

Peripheral Orbital Atherectomy System

Stealth 360 Peripheral Orbital Atherectomy Device
Features

Broad Range of Calcium. One Solution.

The Stealth 360™ Orbital Atherectomy System (OAS) is specifically designed to modify mild to severe calcific plaque in peripheral arteries to restore lumen patency.1 A diamond-coated crown orbits 360 degrees against the vessel wall to get from calcified to compliant, safely and efficiently.2,3

In multiple clinical studies with real-world patients and the most challenging calcified peripheral lesions, OAS has demonstrated successful lesion modification while maintaining low complication rates.4

Stealth 360™ OAS has a Unique Dual Mechanism of Action Design

  • Simultaneously modify intimal5 and medial calcium.4
  • Differentially sand away arterial calcium from athersclerotic tissue, leveraging centrifugal force to facilitate compliance change.2,5
  • Maintain continuous blood flow during treatment.5
  • Achieve low complications6 and lessen the need for bailout stents when used with low pressure PTA.3

Stealth 360™ OAS Gives You the Versatility to Treat Challenging Cases

  • Low-profile design minimizes access site complications7 and improves procedural range.6
  • Allows for non-femoral access options, like transpedal.
  • Prepares small and large vessels for treatment without the need to up-size catheter and sheath size.

 

Stealth 360™ OAS Has Been Proven Effective and Safe in a Full Range of Calcified Lesions

  • Modifies lesions above- and below-the-knee, across a wide range of Rutherford Classes (RC 2-6).6
  • 95% freedom from major amputation at 3 years, RC 4-5.6
  • 89% freedom from amputation at 3 years, RC 6.6
  • Lower max balloon inflation pressure compared to PTA.2,3

References

  1. Das T, et al. Catheter Cardiovasc Interv. 2014;83(1):115-122.
  2. Dattilo R, et al. J Invasive Cardiol. 2014;26(8):355-360.
  3. Shammas NW, et al. J Endovasc Ther. 2012;19(4):480-8.
  4. Mustapha JA, et al. J Crit Limb Ischem. 2021;1(3):E118-E125.
  5. Adams GL, et al. J Cardiovasc Transl Res. 2011;4(2):220-229.
  6. Giannopoulos S, et al. J Endovasc Ther. 2020;27(5):714-725.
  7. Bosiers M, et al. J Endovasc Ther. 2013;20(6):746-56.

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