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Crosser iQ™ Ultrasonic CTO Device

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Overview

The Crosser iQ™ CTO Recanalization System is made up of 3 main components:

The BD Recanalization System (Console and Footswitch) includes a non-sterile, reusable Console with an integrated roller pump, user interface and a Footswitch.

The Crosser iQ™ Ultrasonic CTO Device is connected to the BD Recanalization System Console via the power cord, through which power is converted into high-frequency ultrasonic mechanical vibrations to the tip of the device.

  • Designed to help cross peripheral arterial CTOs intraluminally
  • Automatically and selectively ablates plaque, while remaining atraumatic to elastic tissue
  • Simple, "plug-and-play" system
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    Features and Benefits

    Crosser iQTM 

    Ultrasonic CTO Device
    • 5F sheath compatible, over-the-wire
    • 0.014" guidewire compatible
    • 146 cm working length
    • Handle activation, optional Footswitch
    • Recon™ Support Catheter is designed to guide and provide support for the Crosser iQ™ Ultrasonic CTO Device

     

    Learn more about Recon™ Support Catheter

    BD Recanalization System

    Console and Footswitch
    • Simple, “plug-and-play” system
    • LCD screen with informative prompts
    • Integrated roller pump
    • Average setup time <2-minutes1

    CTOs are Unpredicatable, Crossing Them Shouldn't Be

    The Crosser iQ™ CTO Recanalization System automatically adjusts its power output to help stabilize the distal tip of the catheter to assist in crossing CTOs.

    Products & Accessories

    Crossing Reimagined

    Crosser iQ™ Ultrasonic CTO Device Warranty Program

    BD’s next generation CTO crossing device, the Crosser iQ™ Ultrasonic CTO Device - a smart approach to crossing peripheral CTOs.

    BD is proud to offer the Crosser iQ™ Ultrasonic CTO Device Warranty - if you treat a patient with Crosser iQ™ Ultrasonic CTO Device, per the IFU, and are unsuccessful in crossing the peripheral CTO intraluminally, then a no-charge replacement code will be sent to your account.

    Contact your local BD representative for more details.

     

     

    Program Overview

    Program :  Through December 31, 2022*

     

    Duration : 12 months from Program contract signing**

     

    Criteria : Patient who receives treatment with Crosser iQ™ Ultrasonic CTO Device per the IFU, during this contract period, and the device did not successfully cross through the peripheral chronic total occlusion intraluminally

     

    Warranty : No charge replacement of Crosser iQ™ Ultrasonic CTO Device code sent to account

     

     

     

    ADAPT    

    87% crossing success rate observed
    in 8 cm synthetic lesion model1
     

     

    ANCHOR

    Designed to intraluminally cross unfavorable cap morphologies

    95% CTO cap engagement observed in
    simulated convex cap model2
     

     

     ACCELERATE

    1 minute 29 seconds average activation time observed in 8 cm synthetic lesion model1

    Footnotes

    *BD reserves the right to terminate the Program at any time.

    **Please note, signed Crosser iQ™ Ultrasonic CTO Device Purchase Agreement terms and conditions apply.

    26/30 devices successfully crossed an 8 cm synthetic lesion model made of 10 mm of formula 8 on each end (replicating calcified end caps (no specified cap shape)) and 60 mm of formula 4 (replicating the fibrous middle of a CTO). Crossing success was defined as passing through the entire simulated lesion within 5 minutes or less of device activation. Device activation time ranged from 12 to 290 seconds. Device activation time was measured from the time of device engagement of the simulated lesion until the device crossed through the distal cap of the simulated lesion or until the device life expired and device activation stopped.

    238/40 devices engaged an Ultracal30 gypsum convex cap stone successfully. Engagement success was defined as ability of the device to engage the simulated cap within 30 seconds of device activation.

    Bench data on file, BD, Tempe, AZ. Bench data may not necessarily correlate to clinical performance. Different test methods may yield different results. Actual user experience may vary.

    The BD Recanalization System (Console and Footswitch) and the Crosser iQ™ Ultrasonic CTO Device are indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The Crosser iQ™ Ultrasonic CTO Device is contraindicated for use in the carotid arteries.

    Potential Adverse Events: Bleeding which may require transfusion or surgical intervention· Puncture site hematoma, pain and tenderness · Hemorrhage · Embolism · Vessel perforation/dissection · Guidewire entrapment and/or fracture · Hypertension/Hypotension · Infection or fever · Allergic reaction · Pseudoaneurysm or fistula Aneurysm · Acute reclosure · Thrombosis · Ischemic events · Distal embolization · Excessive contrast load resulting in renal insufficiency or failure · Excessive exposure to radiation · Stroke/CVA · Restenosis · Repeat catheterization/angioplasty · Peripheral artery bypass · Amputation · Death · Other bleeding complications at access site.

    Resources

    Reference

    1 Average set up time of less than 2 minutes is based upon BD internal testing involving four different surgical technicians who set up the BD Recanalization System through step 18 of the Crosser iQ™ Ultrasonic CTO Device instructions for use. Data on file, BD, Tempe, AZ. Bench data may not necessarily correlate to clinical performance. Different test methods may yield different results. Actual user experiences may vary.

     

    Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information.

    BD-29469

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