Stealth 360™

Peripheral Orbital Atherectomy System

Stealth 360 Peripheral Orbital Atherectomy Device

Some debulk. Some fracture.
Stealth 360™ Peripheral Orbital Atherectomy System does both with a single device.

The Stealth 360™ Peripheral Orbital Atherectomy System safely debulks intimal calcium and fractures medial calcium with its unique dual-mechanism of action, offering a comprehensive calcium solution - all with a single device.1-4

Debulks Intimal Calcium + Fractures Medial Calcium

Debulks intimal calcium
Fractures medial calcium

Watch the video to see how the Stealth 360™ Peripheral Orbital Atherectomy System simultaneously debulks intimal calcium and fractures medial calcium.1-4

Stealth 360™ Peripheral Orbital Atherectomy System provides long-term outcomes, proven safety, and high versatility.

Stealth 360 System provides long-tern outcomes, safety and high versatility.

Long-Term Efficacy:

  • 100% freedom from major amputation at 3 years in RC 2-3 (95% in RC 4-5, 89% n RC 6)4
  • 82.1% patency at 1 year (RC 2-3)5
  • 89.7% patency at 2 years (RC 2-3)6
  • Significant would healing in CLTI group (RC 4-6) at 2 years6

Proven Safety Record:

  • Excellent procedural safety7-11
  • Using orbital atherectomy + low pressure PTA resulted in low rate of major adverse events10 and less bailout stents12

Versatile Usage:

  • A single crown can be used in vessels above- and below-the-knee and in different types of calcium and lesions1,2,9,10,12
    • Moderate to severe
    • Soft/hard
    • Short/long
    • Eccentric
    • Concentric
  • Low-profile design can help minimize access site complications13 and improve procedural range4
  • Prepares small and large vessels for treatment without the need to up-size your catheter and sheath size1,2

Explore additional products: Learn how our comprehensive portfolio offers individualized solutions for every step of lower limb intervention, from access to close.

Peripheral artery disease
Peripheral artery disease

References

*Count updated 25 Mar 2020 - subject to change (includes PAD I, PAD II, OASIS, CONFIRM, CALCIUM 360, COMPLIANCE 360, TRUTH, CLARITY I, LIBERTY 360, OPTIMIZE BTK, & REACH PVI)

  1. Adams GL, et al. J Cardiovasc Transl Res. 2011;4(2):220-229.
  2. Mustapha JA, et al. J Crit Limb Ischem. 2021;1(3):E118-E125.
  3. Data on file at Abbott. Clinical Report Memo on Peripheral and Coronary OAS Pulsatile Force and Calcium Fracture. 2021.
  4. Giannopoulos S, et al. J Endovasc Ther. 2020;27(5):714-725.
  5. Mustapha JA. Late Breaking: LIBERTY 360 Trial 2-Year Update. Presented at AMP 2018.
  6. Adams G, et al. J Vasc Surg. 2019;70(5, Suppl):e188-e189.
  7. Martinsen B, Evaluation and Use of Atherectomy Devices for CLI in US, Japan, and EU: Industry View. Presented at VIVA 2017. (Includes directional, rotational, laser)
  8. Data on file at Abbott.
  9. Das T, et al. Catheter Cardiovasc Interv. 2014;83:115-122. (Flow-limiting dissections and embolization were not tracked in 1146 lesions)
  10. Shammas NW, et al. J Endovasc Ther. 2012;19:480-488.
  11. Babaev A, et al. Vasc Endovascular Surg. 2015;49:188-194.
  12. Dattilo R, et al. J Invasive Cardiol. 2014;26(8):355-360.
  13. Bosiers M, et al. J Endovasc Ther. 2013;20(6):746-756.

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