Miniaturized implantable cardiac monitor with a long sensing vector (BIOMONITOR III): Insertion procedure assessment, sensing performance, and home monitoring transmission success
MARIANI J ET AL.,JOURNAL OF ELECTROCARDIOLOGY 2020
- Prospective, open-label, non-randomized, multicenter study
- 48 patients implanted with a BIOMONITOR III, using the FIT OneStep insertion tool at 10 sites in Australia
- Follow-up one week (on-site) and one month (Home Monitoring) after implantation
- To confirm the safety and efficacy of the insertion procedure and of the use and handling of the incision/insertion tools, and to assess the sensing quality of BIOMONITOR III
Key Result 1
BIOMONITOR III shows a high and stable R-wave amplitude
Key Result 2
Clearly visible P-waves in the vast majority of patients
Key Result 3
BIOMONITOR III shows good usability and is easy to handle
- Implantable Cardiac Monitors (ICM) are helpful in the diagnosis of a wide range of rare disorders and pathologies.
- Remote monitoring capabilities of ICMs improve the time to diagnosis and the follow-up strategy and offer a potential reduction of health care costs.
- The Bio|Concept study data confirmed the safety, efficacy and sensing quality of BIOMONITOR III.
|Major Secondary Endpoints||
|Main Inclusion Criteria||
Patients had to have one of the following indications for ICM:
|Main Exclusion Criteria||