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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceWiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
Generic NameLeadless Cardiac Resynchronization Therapy (CRT)
ApplicantEBR Systems, Inc.
480 Oakmead Parkway
Sunnyvale, CA 94085
PMA NumberP240028
Date Received08/29/2024
Decision Date04/11/2025
Product Code SEG 
Docket Number 25M-1081
Notice Date 04/14/2025
Advisory Committee Cardiovascular
Clinical TrialsNCT02922036
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order 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).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 
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