true
Icon to close the modal
Support
Sales
Phone Icon
1.844.8.BD.LIFE (1.844.823.5433)
Modal Close Icon
Contact Us
Icon to close thank you modal
Thank you for contacting our sales team!
A sales representative will get in touch with you shortly.
Onsite Visiting
Location Icon
850 W. Rio Salado Parkway, Tempe, Arizona 85281 United States
Customer Service
Phone Icon
1.844.8.BD.LIFE (1.844.823.5433)
Fax Icon
1.800.440.5376

Rotarex™ Rotational Excisional Atherectomy System

Refined Atherectomy. Built to Remove.

Contact Us
Website_banner_ROT_907x478.jpg
Loading

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.

 

true

Want more information on this product?

Contact Us

Three Distinct Mechanisms of Action

  • 1
  • 2
  • 3

Modifying beveled tip

  • Catheter head and helix rotate at approximately 40,000 rpm with the 8F catheter and 60,000 rpm with the 6F catheter

Rotating abrading vortex

  • Vortex creates additional luminal gain around the cylinder
  • Large side windows further break down and efficiently remove detached material

Continuous active aspiration

  • Internal helix creates negative pressure at the tip to actively aspirate and transport material away

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.

  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7

Drive System

  • Small, portable design.
  • Easy set-up; plug-in and switch on.
  • System is auto-aspirating, without the need for a separate pump.

Switch

  • Operated by hand or optional-use foot switch to facilitate single- or multiple-operator scenarios.
  • Magnetic coupling facilitates ease of use while in the sterile environment.

Ergonomic Handle

  • Easy to use handle designed for single operator control
  • Disposable catheter simply clips to reusable portion of the handle 
  • Included with catheter set

Catheter

  • Designed to perform in a variety of lesions, including complex, mixed morphology occlusions.
  • No defined limitation on treatable lesion length.

Guidewire

  • Nitinol core shaft with PTFE coating for catheter support.
  • Hydrophilically-coated with a flexible, angled tip to enable lesion crossing.
  • Gold-plated tungsten coil to enhance visualization under fluoroscopy.

Optional Foot Switch

  • Operated by foot switch or by handle to facilitate single or multiple-operator scenarios

Collecting Bag & Drape

(not pictured)

  • High volume collecting bag allows for uninterrupted removal of occluding material

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
<h5>STEP ONE:</h5>
<p>Connect power cord</p>
STEP ONE:

Connect power cord

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.

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

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

    NEWS

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

  • ISR-Vertical-Illustration.png

    PRESS RELEASE

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

  • Rotarex-MMB-CathLab.jpg

    NEWS

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

  • Video Player is loading.
    Current Time 0:00
    /
    Duration 50:24
    Loaded: 0.33%
    00:00
    Stream Type LIVE
    Remaining Time -50:24
     
    1x
      • Chapters
      • descriptions off, selected
      • captions off, selected
      • en (Main), selected

      AMP 2020 

      Refining Atherectomy in Challenging Lesions with Mixed Plaque Morphology

    • Video Player is loading.
      Current Time 0:00
      /
      Duration 18:07
      Loaded: 0.91%
      00:00
      Stream Type LIVE
      Remaining Time -18:07
       
      1x
        • Chapters
        • descriptions off, selected
        • captions off, selected
        • en (Main), selected

        AMP 2020

        Atherectomy with Thrombectomy: The Rotarex Rotational Excisional Atherectomy System

      • Straub Logo.png

        PRESS RELEASE

        BD Completes Acquisition of Straub Medical

      Products & Accessories
      Sort by:
      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

      Rotarex™ Rotational Excisional Atherectomy System BD Rotarex™ Rotational Excisional Atherectomy System /content/dam/bd-assets/bd-com/en-us/logos/bd/header-bd-logo.svg

      Refined Atherectomy. Built to Remove.

      Atherectomy, chronic total occlusion(s), CTO, Straub Medical, rotational, excisional, cutting, laser, debulking