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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 minimises 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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CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs.
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