BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Leadless Cardiac Resynchronization Therapy (Crt)

    PMA: P240028 · Decision Apr 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Leadless Cardiac Resynchronization Therapy (Crt)
    Trade Name
    WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
    PMA Number
    P240028
    Device Class
    FDA Class 3
    Product Code
    SEG
    Generic Name
    Leadless Cardiac Resynchronization Therapy (CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 11, 2025
    Date Received
    August 29, 2024
    Expedited Review
    N

    Advisory Committee Statement

    The WiSE CRT System is indicated for adult patients who are at least 22 years of age, are indicated for cardiac resynchronization therapy (CRT), have an existing or are eligible for an implanted right ventricular pacing system, and are in one of the following two categories: • Patients in whom previous coronary sinus (CS) lead implantation was unsuccessful, or where an implanted lead has been turned off, referred to as "previously untreatable"; • Patients with previously implanted pacemakers or Implantable Cardioverter-Defibrillators (ICDs) in whom standard CRT upgrade is not advisable due to known relative contraindications for CS lead or CRT device implantation, referred to as "high risk upgrades". These categories are defined as follows: Previously Untreatable: Patients who have a full or partial CRT system and are deemed as 'previously untreatable' for one of the following reasons: • CS lead implant was attempted but abandoned due any of the following: difficult CS access or anatomy, inadequate lead location, inadequate pacing thresholds, phrenic nerve stimulation (PNS), or other procedural challenges; • Left ventricular (LV) lead that was implanted but not operational including patients in whom the LV lead is inoperative or programmed off due to improper function such as high threshold, non-capture, PNS, lead failure, lead dislodgement, or suboptimal LV lead location. High Risk Upgrades: Patients in whom standard CRT upgrade is not advisable due to known relative contraindication to CS lead implant, for example: • Risk of venous occlusion or lesion precluding implant (e.g., multiple existing leads in situ); • Risk of pocket infection at co-implanted device site (e.g., co-implant initial placement or battery change within last 12 months); • Considered high risk for CS implant due to co-morbidities (e.g., history of Ischemic Cardiomyopathy or Ventricular Tachycardia (VT) with risk of epicardial pacing induced VT). There is insufficient evidence to support the use of the WiSE CRT System in prior CRT non-responders. The safety and effectiveness of the WiSE CRT System has not been established with leadless pacemaker co-implants that utilize conductive communication (e.g., Abbott Aveir).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SEG Leadless Cardiac Resynchronization Therapy (Crt)