Diamondback 360® Peripheral Orbital Atherectomy System – Exchangeable Series


Treat each lesion as its own using the right size crown for the right size vessel. Cartridges come in a variety of length options to support femoral, radial or pedal access for customized procedures and patient benefits. All possible configurations are at your fingertips.



The Diamondback 360 Exchangeable Series with GlideAssist® is our most advanced OAS on the market for complete leg revascularization.

The next gen device allows you to use multiple crowns with one handle to optimize your approach in treating multi-level disease cases.






GlideAssist® Mode

 

GlideAssist enables the crown to spin at a slow speed (5K RPM), reducing friction in the system to*:

  • Facilitate tracking of the device
  • Provide easier removal of the device
  • Allow smoother repositioning of the ViperWire Advance® during procedures
*CSI Data on file


OAS is a Solution for Arterial Calcium

When treating peripheral artery disease (PAD), even with angiography, peripheral calcium tends to be underestimated.9 And studies show that calcium negatively affects patient outcomes.30,32

PATIENT PREDICTORS OF ARTERIAL CALCIFICATION

  • Diabetes
  • Chronic Kidney Disease
  • Advanced Age (>65 y/o)
  • Smoker
  • Dyslipidemia
  • Hypertension
  • Prior CABG
  • Known PAD/CAD

CHALLENGES ASSOCIATED WITH CALCIUM

  • Decreased balloon and stent success31,33
  • Associated with a higher procedural complication rate that may be a predictor of long-term durability30,32
  • High frequency of dissections31

Explore the Exchangeable Series OAS

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The Diamondback 360 has a unique Mechanism of Action designed to:

  • Facilitate crown contact with 360 degrees of the vessel wall
  • Differentially sand away arterial calcium from athersclerotic tissue, leveraging centrifugal force to facilitate compliance change5, 50
  • Maintain continuous blood flow during treatment50
  • Achieve low complications6 and lessen the need for bailout stents5 when used with low pressure PTA


Solid Crown

  • The mass of the crown is designed for maximum calcium removal
  • Diamond-coated surface area allows for short run times

Classic Crown

  • The most flexible of our crown configurations
  • Designed for vessel bends, ostial lesions and distal below-the-knee procedures

Micro Crown

  • Designed with flexibility for tortuous vessels and tight bends below-the-knee

ViperWire Advance® and ViperWire Advance® with Flex Tip Peripheral Guide Wires

ViperWire Advance® and ViperWire Advance® with Flex Tip Peripheral Guide Wires are designed specifically for the Diamondback 360® Peripheral Orbital Atherectomy Systems to facilitate proper device placement within the artery to enable orbital gain during treatment.

ViperSlide® Lubricant

ViperSlide is an exclusive lubricant for use with CSI’s Orbital Atherectomy Systems. ViperSlide increases the lubricity, therefore reducing friction between the device shaft and the ViperWire® Advance Guide Wire.

ViperTrack® Radiopaque Tape

ViperTrack adheres directly to the patient’s skin, providing accurate lesion measurement when using fluoroscopic or radiographic imaging.

OAS Pump

The OAS pump mounts directly onto an I.V. pole and provides power and the pumping mechanism for the Diamondback 360® System.


More Solutions for Peripheral Artery Disease

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  • Liberty360
    LIBERTY 360º
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    Click HERE TO SEE THE LIBERTY 360° Study 3-Year Data LIBERTY is the largest, contemporary, real-world experience study to evaluate procedural and long-term clinical outcomes of endovascular device interventions in patients with symptomatic lower extremity peripheral artery disease (PAD). Study Design1   Prospective, observational, multicenter study that includes any FDA-cleared or approved technology to treat claudication and critical limb ischemia (CLI). 1204 patients enrolled at 51 sites and were followed for up to 5 years. 4 core labs used for independent analysis. Key endpoints: Procedural and lesion success, Major Adverse Events (MAEs), Duplex Ultrasound (DUS), Quality of Life (QoL), and Six-Minute Walk Test (6MWT). Key inclusion criteria: Rutherford classification (RC) 2 to 6, target lesion located within or extending into 10 cm above the medial epicondyle to the digital arteries (distal 1/3 of the SFA and below), and at least one lesion that can be treated with an endovascular device.   Conclusion Peripheral vascular intervention (PVI) may be a reasonable treatment option across all Rutherford classes with durable results lasting to 3-years.2 High freedom from major amputation TVR/TLR at 3 years across all Rutherford classes2 In the OAS sub-analysis, freedom from major amputation TVR/TLV rates at 3 years were even higher than in the full patient cohort2 Improved Quality of Life by 30 days and maintained to 3 years across all Rutherford classes High long-term patency rates through 2 years in RC2-33 Improvement in mean number of wounds from 30 days to 2 years in RC4-63   1. Mustapha et al. One-Year Results of the LIBERTY 360 Study. J Endovasc Ther. 2019;26(2):143-154. 2. Mustapha JA. LIBERTY 360 Trial 3-Year Update. Presented at AMP 2019. 3. Mustapha JA. Late Breaking: LIBERTY 360 Trial 2-Year Update. Presented at AMP 2018.
  • CALCIUM-360
    CALCIUM 360º
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    A prospective, randomized, multi-center study that compared the acute and long-term results of Orbital Atherectomy System (OAS) + percutaneous transluminal angioplasty (PTA) versus PTA alone in calcified below-the-knee (BTK) lesions. Key Takeaways Lower mean maximum balloon inflation pressure in OAS+PTA arm Lower rate of major adverse events at 12-months in OAS+PTA arm Study Design 50 Critical Limb Ischemia (CLI) patients enrolled at 8 U.S. sites Patients randomized to either OAS+PTA (25 pts) or PTA alone (25 pts) and followed for 12 months
  • Truth Clinical Study
    TRUTH
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    A prospective, single-arm, single-center study using intravascular ultrasound (IVUS) to assess Orbital Atherectomy System (OAS)-related plaque modification of femoropopliteal lesions. Key-Takeaways OAS modified the calcified component of the plaque burden (IVUS analysis) Calcium reduction was responsible for 86% of lumen area increase (IVUS analysis) Increase in minimum lumen area post-OAS (IVUS analysis) Low mean maximum balloon inflation pressure post-OAS of 5.2 atm Study Design 25 patients enrolled at a single center Patients treated with OAS+ percutaneous transluminal angioplasty (PTA) and followed for 12 months IVUS images collected pre-OAS, post-OAS, and post-PTA (IVUS Core Lab)
  • Compliance360
    COMPLIANCE 360º
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    A prospective, randomized, multi-center study that compared the acute and long-term results of Orbital Atherectomy System (OAS) + percutaneous transluminal angioplasty (PTA) versus PTA alone in calcified above-the-knee (ATK) lesions. Key Takeaways Lower mean maximum balloon inflation pressure in OAS+PTA arm Lower adjunctive stent rate in OAS+PTA arm OAS demonstrated reduced stenting with durable results out to 12 months versus PTA alone Study Design 50 patients enrolled at 9 U.S. sites Patients randomized to either OAS+PTA (25 pts) or PTA alone (25 pts) and followed for 12 months
  • OPTIMIZE - Follow-Up Phase
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    OPTIMIZE is a prospective, randomized one to one (1:1), multi-center European pilot study designed to evaluate Orbital Atherectomy vessel preparation prior to drug coated balloons (DCBs) compared to DCB alone for the treatment of calcified below-the-knee lesions. Study Design Approximately 50 patients will be enrolled at up to 10 European sites and followed for up to 2 years Late lumen loss at 6 months post-procedure will be an outcome measure
  • REACH PVI
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    REACH PVI is a prospective, observational, single-arm, multi-center, post-market clinical study designed to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions. Study Design Approximately 50 subjects will be enrolled at up to ten (10) active sites in the United States (U.S.) The primary outcome is defined as successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access related events Subjects will be followed post-procedure through the first standard of care follow-up visit (7-45 days post procedure)