Healthcare Professionals

Explore the groundbreaking results of the SOLVE-CRT trial, a pivotal study stopped early for success at the pre-specified interim analysis. This trial demonstrated safety and effectiveness of the WiSE CRT System with conventional CRT who were previously untreatable or considered high risk upgrades. 

Pivotal SOLVE-CRT Trial Meets Endpoints: Excellent Interim Analysis Results Lead to Early Trial Halt for Success

The SOLVE-CRT trial evaluated patients indicated for CRT who were previously untreatable or considered high risk upgrades. The study found that the WiSE CRT System, the only leadless left ventricular endocardial pacing (LVEP) device, can safely deliver CRT.

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16.4%

improvement in left ventricular end systolic volume (LVESV) in heart failure patients in the first 6-months

80.9%

of patients had no serious device and procedure-related complications in the first 6-months

eIFU

From this site you can view eIFUs andPatient Information Booklets (PIB). Please note that product literature varies by geography. Use only product literature from the region where the patient procedure was performed. Manuals are subject to change; the most current version is available on this page.

WiSE CRT

WiSE CRT Common Section IFU

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Ultrasound Illustration

Ultrasound and Alternative EchoTechniques

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The information should be carefully reviewed and followed when using any device. Failure to follow the instructions may result in unacceptable performance and increased risk of patient harm.

If you do not find the desired documents foryour region or would like to request a paper/emailed copy, please visit our Contact page.

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2022 Meta-analysis

A 2022 meta-analysis by Wijesuriya et al. consolidated findings from five pivotal studies conducted between 2014 and 2021. These studies collectively analyzed the outcomes of 175 HF patients who underwent the WiSE CRT System implantation. Key findings include:

Improved echocardiographic response:

Average improvement in LVEF of 6.3% between baseline and 6-month follow-up across all 5 studies.

Improved NYHA classification:

Mean reduction of New York Heart Association (NYHA) class of 4.3 points.

Improved clinical response:

The pooled clinical response rate was 68% between baseline and 6-month follow-up.

High implant and procedural success:

Implant success rate was 96.6% with four studies reporting biventricular capture at six months in 90.6% of patients.

Limitations:

Non-randomized patients, small number of studies, heterogeneity of inclusions criteria, and a short follow-up duration of six months.

Conclusions and future directions:

Efficacy of leadless left ventricular endocardial pacing with the WiSE CRT System was shown, supporting its use as a second-line therapy in patients in whom standard CRT has failed or is not possible.

*Wijesuriya N, Elliott MK, Mehta V, et al.Leadless left ventricular endocardial pacing for cardiac resynchronization therapy: A systematic review and meta-analysis. Heart Rhythm2022;19(7):1176-1183. DOI: 10.1016/j.hrthm.2022.02.018.

WiSE Clinical Program

Studies demonstrate on-going clinical impact of WiSE CRT System, the leadless left ventricular endocardial pacing (LVEP) solution.

WiSE-CRT
SELECT-LV
Post Market Surveillance Registry
SOLVE-CRT
Study Design
Single-arm, safety and feasibility
Single-arm, safety and efficacy
Real-world safety and performance
Single-arm, Roll-in
Pivotal: randomized and single-arm
# of Patients
13
34
153
31
183
# of Sites
11
7
19
68
Regions
EU
EU
EU, UK
AU, EU, UK, US

Publications

Clinical Study References

Pre-clinical Study References