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Rotarex™ Rotational Excisional Atherectomy System

Refined Atherectomy. Built to Remove.

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Atherectomy + Thrombectomy For Mixed Morphology PAD lesions

The Rotarex™ Atherectomy System is designed to efficiently remove both plaque and thrombus by utilizing three distinct mechanisms of action to treat PAD lesions including in-stent restenosis. The device modifies, excises, and aspirates complex lesions with mixed plaque morphology with two different size options—6F & 8F.



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Three Distinct Mechanisms of Action

    Refined Atherectomy

    Indicated for the use in peripheral arteries for:

    • Native Bypass
    • Artifical Bypass
    • Stent Grafts
    • In-Stent Restenosis
    • Atherectomy
    • Thrombectomy


    Simple Setup and Small Foot Print:

    We understand that anything that can help to save time and 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>

      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

      Rotarex Atherectomy System Meta-Analysis

      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/OutcomesMean (95% CI)
      Age68.1 (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 Success95.8% (94.3%, 97.3%)
      Clinical Success79.9% (75.2%, 84.5%)
      TLR at 6 Months7.8% (1.0%, 14.5%)
      TLR at 12 Months11.3% (7.4%, 15.3%)
      Restenosis at 6 Months16.9% (0.0%, 35.3%)
      Restenosis at 12 Months35.5% (19.6%, 51.4%)


      Measure/OutcomesMean (95% CI)
      ABI at 6 Baseline0.33 (0.18, 0.47)
      ABI at 6 Months0.83 (0.78, 0.88)
      ABI at 12 Months0.77 (0.71, 0.82)
      Rutherford Score at Baseline3.54 (3.42. 3.67)
      Rutherford Score at 6 Months1.51 (1.03, 2.00)
      Rutherford Score at 12 Months2.13 (1.83, 2.42)
      Procedure-Related Dissection5.9% (3.3%, 8.6%)
      Procedure-Related Embolization7.5% (4.7%, 10.4%)
      Procedure-Related Perforation2.2% (0.9%, 3.4%)
      Procedure-Related Pseudo-Aneurysm1.5% (0.6%, 2.4%)
      Procedure-Related Abrupt Reocclusion2.4% (1.0%, 3.7%)


      Case examples

      Chronic total occlusion of the superficial femoral artery
      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.&nbsp; Salt Lake City, UT, USA</h3>

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

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

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

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

      Dr. John Park, MD. Omaha, NE, USA

      Peer to Peer Program

      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

      1.  Rotarex™ Atherectomy System eIFU

      2.  All case images are courtesy of the various clinicians

      News & Media

      • CLD Logo.png


        February 2022, Cath Lab Digest 

        Leipzig’s Experience Using Rotarex™ Rotational Excisional Atherectomy for In-Stent Reocclusion in Peripheral Arterial Occlusive Disease

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      • ISR-Vertical-Illustration.png


         Oct 17, 2021, PR News Wire

        BD Announces 510(k) Clearance of Expanded Indications for the Rotarex™ Atherectomy System

        Learn More

      • Rotarex-MMB-CathLab.jpg


        September 2020, Cath Lab Digest 

        Rotational Excisional Atherectomy With the Rotarex™ Atherectomy Device – Miguel Montero-Baker, MD

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      • AMP 2020 

        Webinar with Ian Cawich, MD & Raymond Dattilo, MD, FACC

        Refining Atherectomy in Challenging Lesions with Mixed Plaque Morphology

      • AMP 2020

        Webinar with George Adams, MD

        Atherectomy with Thrombectomy: The Rotarex Rotational Excisional Atherectomy System

      • Straub Logo.png


        Jun 1, 2020

        BD Completes Acquisition of Straub Medical

        Learn More

      Products & Accessories


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