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Rotarex™ Rotational Excisional Atherectomy System

Refined Atherectomy. Built to Remove.

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Overview

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
    • Artificial 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>
      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

      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

      EIFUs

      Access available EIFUs using the button below

      If the EIFU is unavailable please consult your Representative or check the product labeled IFU. 

       

      Click Here

      Resources
      Reference

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

      BD-27143v5