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Rotarex™ Rotational Excisional Atherectomy System
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Overview

Refined Atherectomy. Built to Remove.

Atherectomy + Thrombectomy For Mixed Morphology PAD lesions


The Rotarex™ Rotational Excisional Atherectomy System synchronizes three distinct mechanisms of action to modify, excise and aspirate complex lesions with mixed plaque morphology

  • Dual Indication
    • Indicated for peripheral arterial atherectomy + thrombectomy
    • Designed for multiple plaque morphologies
  • Advanced Aspiration
    • 45-75 mL per minute
    • Large collection windows
    • Internal mechanism further breaks down material as it is aspirated
  • Simple to set up and use
    • Small footprint
    • No warm-up, infusion, or repeated catheter clean-out required
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Refined Atherectomy. Built to Remove

Atherectomy + Thrombectomy For Mixed Morphology PAD lesions

    Indicated for Use in the Peripheral Arteries for:

     

    ✔ Native Bypass
    ✔ Artificial Bypass
    ✔ Stent Grafts
    ✔ In-Stent Restenosis
    ✔ Atherectomy
    ✔ Thrombectomy
    • Atherectomy + Thrombectomy

      PAD lesions can be complex, Rotarex™ Atherectomy System is dual indicated for atherectomy and thrombectomy

    • Continuous Active Aspiration

      Aspiration rates of 45-75ml/min to help ensure removal of plaque and acute to chronic thrombus

    • Additional Luminal Gain with No External blades

    • Helps Minimize Distal Embolization

      Rotarex™ Atherectomy Device is designed to efficiently remove debris by utilizing the largest active aspiration windows in the atherectomy market*

    Built to Remove

    The Rotarex™ Rotational Excisional Atherectomy System synchronizes three distinct mechanisms of action to modify, excise and aspirate complex lesions.

    Simple Setup and Small Foot Print:

    We understand that anything that can help to save time, space and reduce complexity in the lab is essential. The Rotarex™ Atherectomy System is simple to set up and easy to use, with a small plug-and-play capital component and reusable handle that is easily draped. Additionally, the Rotarex™ Atherectomy System does not require any warm up, infusion or catheter clean out.

      Ready-to-use in 5 Simple Steps

      
                  

      Step One Step One
      Step One
      Step Two Step Two
      Step Two
      Step Three Step Three
      Step Three
      Step Four Step Four
      Step Four
      Step Five Step Five
      Step Five
      <h5>STEP ONE:</h5>
<p>Connect power cord</p>
      STEP ONE:

      Connect power cord

      <h5>STEP TWO:</h5>
<p>Connect motor to drive system</p>
      STEP TWO:

      Connect motor to drive system

      <h5>STEP THREE:</h5>
<p>Drape motor and drive system</p>
      STEP THREE:

      Drape motor and drive system

      <h5>STEP FOUR:</h5>
<p>Remove catheter from packaging and connect collecting bag</p>
      STEP FOUR:

      Remove catheter from packaging and connect collecting bag

      <h5>STEP FIVE:</h5>
<p>Press catheter onto motor then flush</p>
      STEP FIVE:

      Press catheter onto motor then flush

      *Limited to rotational atherectomy devices with active aspiration on the U.S. market, as of May 2021

      Reference

      Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions and directions for use.

      BD-27143v4

      true

      The Rotarex™ Atherectomy System has been Studied in Over 2,100 Patients.1

      A meta-analysis of 8 clinical studies comprising data obtained from 2,107 patients studied from 2002 to 2015 was performed to*:

      • Establish Rotarex™ Atherectomy System clinical performance
      • Provide a quantitative review and synthesis of the results of related but independent studies of the Rotarex™ Atherectomy Device

       

      Measure/Outcomes Mean (95% CI)
      Age 68.1 (66.4, 69.7)
      Gender (% Male) 65.3% (60.6%, 70.0%)
      Rotarex™ Device Treatment Time (minutes) 3.0 (1.3, 4.7)
      Lesion Length (mm) 153.96 (115.24, 192.69)
      Technical Success 95.8% (94.3%, 97.3%)
      Clinical Success 79.9% (75.2%, 84.5%)
      TLR at 6 Months 7.8% (1.0%, 14.5%)
      TLR at 12 Months 11.3% (7.4%, 15.3%)
      Restenosis at 6 Months 16.9% (0.0%, 35.3%)
      Restenosis at 12 Months 35.5% (19.6%, 51.4%)

       

      Measure/Outcomes Mean (95% CI)
      ABI at 6 Baseline 0.33 (0.18, 0.47)
      ABI at 6 Months 0.83 (0.78, 0.88)
      ABI at 12 Months 0.77 (0.71, 0.82)
      Rutherford Score at Baseline 3.54 (3.42. 3.67)
      Rutherford Score at 6 Months 1.51 (1.03, 2.00)
      Rutherford Score at 12 Months 2.13 (1.83, 2.42)
      Procedure-Related Dissection 5.9% (3.3%, 8.6%)
      Procedure-Related Embolization 7.5% (4.7%, 10.4%)
      Procedure-Related Perforation 2.2% (0.9%, 3.4%)
      Procedure-Related Pseudo-Aneurysm 1.5% (0.6%, 2.4%)
      Procedure-Related Abrupt Reocclusion 2.4% (1.0%, 3.7%)

       

      * The statistical treatment of the data summarized in the table above endpoints with an adequate number of data points (>2). SAS v9.3 (SAS Institute, Cary, NC) was used to pool data and calculate all estimates. For each clinical outcome, a random effects model was executed to calculate pooled estimates per group, as well as the corresponding confidence

       

      CTO Left SFA Dr. Bruno Freitas, MD, Prof. Santa Casa de Marveió, Federal University of Alagoas2

      64-year-old male patient presented with left-sided CLI. Over the preceding four months the patient experienced left-sided rest pain and despite receiving best medical treatment, developed a dry, non-healing ulcer of the toe. Puncture of the right groin and cross-over approach, demonstrated a very long, 31 cm, TASC D, femoropopliteal CTO on angiogram. The SFA occlusion was recanalized with a wire intraluminally, followed by 3 passes of a 6F Rotarex S™ Atherectomy Catheter, after which 3 PTAs resulted in a completely restored flow. The patient remained asymptomatic after 18 months.

      
                  

      <h3>Before treatment, Flush occlusion of left SFA to PII segment. Crossed intraluminally with guidewire.</h3>

      Before treatment, Flush occlusion of left SFA to PII segment. Crossed intraluminally with guidewire.

      <h3>Extensive collaterals of SFA reconstituting at PII segment, with 2 vessel run-off BTK.</h3>

      Extensive collaterals of SFA reconstituting at PII segment, with 2 vessel run-off BTK.

      <h3>Angiogram after 1 and 3 passes with Rotarex™ Atherectomy Catheter.</h3>

      Angiogram after 1 and 3 passes with Rotarex™ Atherectomy Catheter.

      <h3>Final angiogram showing restored flow in SFA and 3 vessel run-off BTK.</h3>

      Final angiogram showing restored flow in SFA and 3 vessel run-off BTK.

      In-Stent Restenosis Cases

      
                  

      Case 1 Case 1
      Case 1
      Case 2 Case 2
      Case 2
      Case 3 Case 3
      Case 3
      <h3>Dr. Aaron Frodsham, MD. Evolve Medical. Salt Lake City, UT, USA</h3>

      Dr. Aaron Frodsham, MD. Evolve Medical. Salt Lake City, UT, USA

      <h3>Dr. Aaron Frodsham, MD. Evolve Medical. Salt Lake City, UT, USA</h3>

      Dr. Aaron Frodsham, MD. Evolve Medical. Salt Lake City, UT, USA

      <h3>Dr. John Park, MD. Methodist Physicians Clinic. Omaha, NE, USA</h3>

      Dr. John Park, MD. Methodist Physicians Clinic. Omaha, NE, USA

      1 Rotarex™ Atherectomy System IFU
      2 The clinical experiences presented herein are for informational and educational purposes only. The results presented may not be predictive for all studies and patients. Results may vary depending on a variety of experimental and clinical parameters, as well as patient specific attributes. The treatments described in this presentation represent those of the presenting physician. Please consult product labeling for appropriate use.

      Reference

      Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions and directions for use.

      BD-27143v4

      true

      In-Stent Restenosis Cases

      BD is proud to offer you this exclusive learning opportunity to further support your Peripheral Arterial Disease (PAD) education and training with the use of our Rotarex™ Rotational Excisional Atherectomy System. We are committed to making your educational learning with BD Peripheral Intervention (BDPI) a success.

      Faculty are available to answer questions about the Rotarex™Rotational Excisional Atherectomy System, such as: Case/Patient Selection, Device Set Up, Recommendations for Device Use, or Discuss Your Experience With An Expert.

      Click here to learn more about the Peer to Peer Program

      Advertorial with Dr. Montero-Baker

      CathLab Digest September 2020

      Rotational Excisional Atherectomy With the Rotarex™ Atherectomy Device

      CLD talks with Miguel Montero-Baker, MD, Associate Professor of Surgery, Division of Vascular Surgery and Endovascular Therapy; Associate Clinical Chief, Division of Vascular Surgery and Endovascular Therapy.

      Read Full Article

      Webinar with Dr. Cawich and Dr. Datillo

      Webinar with Dr. Adams

      Reference

      Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions and directions for use.

      BD-27143v4

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      Products & Accessories
      References

      Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions and directions for use.

      BD-27143v4

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      Resources
      References

      Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions and directions for use.

      BD-27143v4

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