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