Icon to close the modal
Support
Sales
Phone Icon
1.844.8.BD.LIFE (1.844.823.5433)
Modal Close Icon
Sales Form
Please fill out the form and a sales representative will get in touch with you.

Capability:

Product Line:

Icon to close thank you modal
Thank you for contacting our sales team!
A sales representive will get in touch with you shortly.
Ordering
Phone Icon
1.844.8.BD.LIFE (1.844.823.5433)
Onsite Visiting
Location Icon
850 W Rio Salado Pkwy, Tempe, AZ 85281 United States
Customer Service
Phone Icon
1.844.8.BD.LIFE (1.844.823.5433)
6:00 a.m. – 4:30 p.m. Arizona Time (Monday-Friday)
Fax Icon
1.800.440.5376
Rotarex™ Rotational Excisional Atherectomy System

Refined Atherectomy. Built to Remove.

Contact Us navigation arrow
Background Image
Loading
tabs dropdown arrow
Overview

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

INDICATED FOR THE USE IN THEPERIPHERAL ARTERIES FOR :

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

 

Built to Remove

The Rotarex™ Rotational Excisional Atherectomy System synchronizes three 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

    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.

    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

    Products & Accessories
    Resources
    Reference

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

    BD-27143v4

    true
    Chat with us
    Our live chat is available between the hours of 8.30am - 5.00pm EST, Monday - Friday
    ×