Image Credit: Abbott
Abbott announced that it has received the CE Mark for its ASSERT-IQ Implantable Loop Recorder. Abbott received FDA approval for the device almost a year ago (May 2023). The Assert-IQ EL+ offers the world’s longest battery life (up to 6 years) for a Bluetooth® enabled ILR.
Image Credit: Angel Medical Systems
In May 2023 AngelMed changed its name to Avertix. AngelMed developed the Guardian System, which is an FDA-approved implantable device designed to detect and warn patients of acute thrombotic coronary occlusion.
BIOS Acquisition Corporation, a special purpose acquisition company, then announced that it had entered into a definitive merger agreement with Avertix so it would become a publicly traded company on Nasdaq. The Transaction is expected to close in the second half of 2023. According to the announcement, the combined company, which will be named Avertix Medical, Inc., will have an enterprise value of approximately $195 million.
Image Credit: Biotronik
FDA has cleared Biotronik’s Vital Data Sensor to identify body temperature increases potentially associated with fever as part of its new Biomonitor IIIm injectable cardiac monitor (ICM).
The device has shown to achieve a 72 percent reduction in false positives while maintaining 100 percent of AF-related sensitivity. It removes single ectopic beats out of the AF detection algorithm, enhancing diagnostic accuracy.
According to Biotronik, “BIOMONITOR IIIm is the industry leader in battery longevity with 5.5 years of continuous service, providing long-term post-ablation or cryptogenic stroke monitoring. It is also backed by the Patient App, which allows patients to include vital symptom data, providing physicians with symptom-rhythm correlation which strengthens diagnostic precision.”
Image Credit: Boston Scientific
FDA has 510(k)-cleared the LUX-Dx™ Insertable Cardiac Monitor (ICM), which is a long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope
According to the announcement:
“The new LUX-Dx ICM System is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making. Further, the remote programming capabilities of the device via the LATITUDE Clarity™ Data Management System website allow physicians and care teams to adjust event detection settings without requiring an in-person patient appointment, a feature unavailable on any other ICM currently on the market.
…
The dual-stage algorithm within the LUX-Dx ICM System can be programmed to identify AF, atrial flutter, rhythm pause, bradycardia and tachycardia episodes and allows the device to detect arrhythmias each time established thresholds or parameters are exceeded. An additional level of verification filters is then applied, which was developed to catch false positive detections before an alert is sent. Additionally, after implant, patients are provided with a mobile device preloaded with the MyLUX™ app which connects via Bluetooth® to their ICM device. The app transmits device data daily, or as needed, to the LATITUDE Clarity Data Management System giving physicians and care teams timely access to vital information.”
Image Credit: Abbott
Abbott released a very nice video on the (St Jude Medical) CONFIRM Rx Implantable Loop Recorder (ILR):
An interesting interview with Avi Fischer, M.D., divisional vice president and medical director of Abbott’s cardiac rhythm management business about the impact of the CONFIRM Rx Implantable Cardiac Monitor was published today by Medgadget.
Walking through MD&M is always fun because component and assembly companies often display implantable devices that never made it to market or technologies that they are incorporating into brand new devices that have not yet reached prime time.
AJ Medical’s CardioAlarm is a sample of an implantable device that didn’t quite made it. It was meant to automatically detect cardiac arrest and use a wirelessly-connected pager-like device to alert bystanders and call 911.
As many other alert implantable medical devices, CardioAlarm didn’t make it to market. The latest victim being Angel Medical needing to seek Chapter 11 bankruptcy protection soon after achieving FDA approval for its Guardian Implantable Heart Attack Monitor, although hopefully this is just a financial restructuring exercise to gear up for full commercialization of the device.
Medtronic’s new Reveal LINQ Insertable Cardiac Monitor is a tiny implantable device that weighs less than three grams and is far less invasive than any previous loop recorder. The figure above shows its diminutive size compared to the Reveal XT device – it is a full 87% smaller!
The Reveal LINQ is a leadless device that is implanted in the region of the thorax by way of a <1cm incision. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias.
Reveal LINQ stores a total of 57 minutes of ECG, including 27 minutes of automatically-detected episodes and up to 30 minutes of patient-activated recordings with 6.5–14 min. buffers.
The device connects wirelessly with Medtronic’s MyCareLink™ Patient Monitor, making the Reveal LINQ ICM the only ICM to collect and trend data continuously and wirelessly.
Biotronik announced the European market release of BioMonitor®, an implantable cardiac device designed for the highly accurate and reliable monitoring and management of patients with atrial fibrillation (AF) or unexplained syncope.
According to Biotronik’s press release:
“BioMonitor® is a subcutaneous implantable leadless cardiac monitor for the long-term continuous remote monitoring of patients with arrhythmias such as AF, bradycardia, sudden rate drop, asystole and tachycardia.
As sensitivity and specificity are essential in the detection of arrhythmias such as AF, BIOTRONIK has developed ClearSense Technology with a unique three-vector signal detection that produces highly precise and reliable arrhythmia monitoring.
The Medtronic Chronicle implantable hemodynamic monitor used a specialized RV lead/sensor. The device was able to monitor and telemeter:
Transoma was the name that Data Sciences International of St Paul, MN adopted in 2003 when it re-fucused its animal telemetry implant business to develop an implantable wireless system to capture electrocardiogram data for diagnosing human cardiac arrhythmias, as well as to monitor the electrical activity of the heart and transmit data from the patient’s home to monitoring centers.
In 2007, Transoma received FDA’s approval for its Sleuth implantable device to wirelessly monitor a patient’s ECG for possible diagnosis of arrhythmias and prevention of syncopal episodes. The Sleuth ECG Monitoring System included a High Definition Implantable Loop Recorder (HD-ILR), a Personal Diagnostic Manager, a Base Station and a Monitoring Center staffed 24/7. Continue reading