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Evolution RL & Evolution Shortie RL Controlled-Rotation Dilator Sheath Set

Safe, Effective, and Efficient for TLE*

The Evolution® RL helps you extract leads by separating binding adhesions along the entire length of your targeted cardiac lead. The PTFE outer sheath can be used to disrupt tissue and apply countertraction.

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    Features & Benefits

    Rotational transvenous lead extraction (TLE) is safe, effective, and efficient when using the Evolution RL as a first choice.1

    0

    isolated extrapericardial SVC injuries1,3

    4 minutes

    median extraction time per lead1

    7.2x

    lower mortality rate than laser sheaths2

    A 2019 retrospective by Diaz, et al., compiled and analyzed over 50,000 lead extraction procedures and determined that lead extraction with laser sheaths appears to be associated with a higher risk of mortality.2

    A 2020 retrospective study (PROMET) by Starck, et al., was the largest study with rotational devices as the primary extraction device. Laser use was nearly abandoned in the first half of the study, and the authors concluded “the low incidence of injury to the SVC demonstrated in the PROMET study constitutes a major advance in TLE.”3

    In 2021, the prospective RELEASE study by Sharma, et al., found high clinical success and efficient extraction times per lead despite a median indwell time of 7.4 years.1

     

     

    Designed to provide physicians with the most control and user feedback during lead extraction procedures.

    98.4% of leads with an implant duration of >10 years were removed with complete success.6 Clinical success rates were >99%.4,5,6

    Evolution RL with a callout showing the Decagon Tip detail

    CONTROL

    • The amount of sheath rotation is directly proportional to the length of the trigger pull—unlike powered devices, which have a preset energy that is triggered upon activation.
    • You can control both the direction and speed of rotation.

    BALANCED FLEXIBILITY AND STABILITY

    • The Evolution device gives you the flexibility to maneuver through challenging anatomy.4
    • Benefit from stability when engaging with dense and calcified adhesions.5,6

    BIDIRECTIONAL EXTRACTION

    • The Evolution device actively extracts leads while rotating in either direction.

    DECAGON TIP

    • The ten-sided tip is designed to peel the leads away from scar tissue.
    • The device disrupts tissue directly in contact with the tip, without forward extending blades.

    NO LEAD WRAP OR DAMAGE 

    • Studies have shown no occurrences of lead wrap or damage to companion leads.5,6,7

     

     

    Evolution Shortie RL with callout showing tip detail
    Evolution Shortie RL Controlled-Rotation Dilator Sheath Set

    Access every lead

    The Evolution Shortie RL is built specifically for vessel entry into the subclavian veins. The Shortie RL combines all the control features of the Evolution RL with a shorter, stiffer sheath and an enhanced tip to facilitate entry through dense scar tissue and calcification.

     

     

    REFERENCES

    1. Sharma S, Lee BK, Garg A, et al. Performance and outcomes of transvenous rotational lead extraction: results from a prospective, monitored, international clinical study. Heart Rhythm O2. 2021;2(2):113–121.
    2. Diaz CL, Guo X, Whitman IR, et al. Reported mortality with rotating sheaths vs laser sheaths for transvenous lead extraction. Europace. 2019;21(11):1703–1709.
    3. Starck CT, Gonzalez E, Al-Razzo O, et al. Results of the patient-related outcomes of mechanical lead extraction techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques. Europace. 2020;22(7):1103-1110.
    4. Sharma S, Ekeruo IA, Nand NP, et al. Safety and efficacy of transvenous lead extraction utilizing the Evolution mechanical lead extraction system: a single-center experience. JACC Clin Electrophysiol. 2018;4(2):212-220.
    5. Migliore F, Testolina M, Sagone A, et al. Multicentre experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: safety, effectiveness and outcome. Pacing Clin Electrophysiol. 2019;42(7):989–997.
    6. Mazzone P, Migliore F, Bertaglia E, et al. Safety and efficacy of the new bidirectional rotational Evolution mechanical lead extraction sheath: results from a multicentre Italian registry. Europace. 2018;20(5):829–834.
    7. Starck CT, Steffel J, Caliskan E, et al. Clinical performance of a new bidirectional rotational mechanical lead extraction sheath. Europace. 2016;18(2):253–256.

    Evolution is a trademark of Cook Medical Technologies, LLC.

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    Documents

     

    Current IFUs
    Evolution® RL Controlled-Rotation Dilator Sheath Set – IFU (Multilingual)
    Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set – IFU (Multilingual)

    The Instructions for Use (IFU) provided on this page are for general information purposes only. Please refer to the IFU provided with the actual product for indications, contraindications, warnings, precautions, and directions for use.
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    Order Information

    Evolution RL 

    Catalog Numbers Inner Sheath ID Fr Outer Sheath ID Fr Inner Sheath length cm
    LR-EVN-9.0-RL 9.0 17.2 40.6
    LR-EVN-11.0-RL 11.0 19.4 40.6
    LR-EVN-13.0-RL 13.0 21.3 40.6 

     

    Evolution Shortie RL

    Catalog Numbers Inner Sheath ID Fr Outer Sheath ID Fr Inner Sheath length cm
    LR-EVN-SH-9.0-RL 9.0 17.2 13.6
    LR-EVN-SH-11.0-RL 11.0 19.4 13.6

    408315001_001  ID 081525