A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Atrial Flutter/Fib

Implantable devices for the treatment of atrial flutter and fibrillation

FDA Clears Vital Data Sensor in Biotronik’s Biomonitor IIIm ICM

Posted on by Posted in Atrial Flutter/Fib, Biotronik, Bradycardia, ECG Monitoring

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.”

Nice Abbott Video on CONFIRM Rx ILR

Posted on by Posted in Abbott, Atrial Flutter/Fib, Bradycardia, ECG Monitoring, St. Jude Medical, Tachycardia

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.

Cardialen’s Unpinning Termination Antiarrhythmic Therapy

Posted on by Posted in Atrial Flutter/Fib, Cardialen, Tachycardia

Cardialen, Inc. is a private company based in Minneapolis, MN. It was established in 2008 to develop an implantable defibrillator using low-electrical energy to restore normal heart rhythm and potentially avoid the negative side-effects of high-energy cardioversion shocks. The therapy is based on work by bioengineer Igor Efimov, whose federally-funded laboratory at George Washington University developed a way to defibrillate the heart without high-voltage shocks. Known as “unpinning termination” (UPT), the technique involves using a precisely timed series of low-voltage pulses to terminate an arrhythmia.

On October 2018 Cardialen announced that it had raised $17 million in a Series B funding round toward its goal. Cardialen stated that this funding would be used to continue clinical testing of the UPT concept in humans, and to start development of an implantable device to deliver the therapy.

Cardialen’s website:  http://www.cardialen.com/

Medtronic Advisa and Revo MRI SureScan Pacemakers Delays Atrial Fibrillation Disease Progression

Posted on by Posted in Atrial Flutter/Fib, Bradycardia, Cardiac Pacing, Medtronic

Medtronic Advisa www.implantable-device.com David Prutchi PhD

Results for the MINERVA Trial were presented at the AHA Meeting, showing that  Medtronic Advisa and Revo MRI(TM) SureScan(TM) pacemakers reduce the progression of permanent AF by 61%.  According to the press release:

Presented as a late breaking clinical trial at the American Heart Association’s Scientific Sessions 2013, the MINERVA (MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure) study found that Medtronic pacemakers with atrial antitachycardia pacing (Reactive ATP(TM)), managed ventricular pacing (MVP®) and atrial intervention features were able to significantly decrease the incidence of mortality, cardiovascular hospitalizations or permanent AF at two years compared to pacemakers without these features. The effects of these features were most evident by a significant delay in the progression of atrial tachyarrhythmias to permanent AF, with a 61 percent relative risk reduction at two years.

Continue reading→

Biotronik Launches Implantable BioMonitor for Monitoring Arrhythmias

Posted on by Posted in Atrial Flutter/Fib, Biotronik, Dementia, ECG Monitoring, Tachycardia, Telemetry

Biotronik BioMonitor to diagnose arrhythmias. David Prutchi PhD www.implantable-device.comBiotronik 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.

Continue reading→

InControl’s Metrix Atrioverter (1990-1998)

Posted on by Posted in Atrial Flutter/Fib, Boston Scientific, Cardioversion/Defibrillation, Guidant, History, InControl

InControl Metric Atrioverter InControl was founded in 1990 in Redmond, WA to develop an implantable device for treating atrial fibrillation.  In November 1995, InControl announced the first human implant of its Metrix atrioverter.

The implantable atrioverter system consisted of an implantable atrial defibrillator (model 3000 or 3020) connected to right atrial (perimeter right atrial model 7205) and coronary sinus (perimeter coronary sinus model 7109) defibrillation leads and a bipolar endocardial ventricular pacing lead, a programmer, and a defibrillation systems analyzer. The device had a volume of 53cc and weighed 79 g (model 3000) or 82 g (model 3020).

The device detected AF and delivers R-wave synchronous defibrillation shocks to convert AF to sinus rhythm. It was also able to pace the ventricle after shock delivery in case of bradycardia. Shocks could be delivered at a selected voltage up to 300V. The model 3000 defibrillator had an 80µF capacitor and could deliver a maximal shock of 3J with a biphasic waveform of 3 ms/3 ms. The model 3020 defibrillator had a 160-µF capacitor with a maximal shock of 6J with a biphasic waveform of 6 ms/6 ms. Continue reading→

AIMD Companies Founded by Mir A. Imran (InCube)

Posted on by Posted in Atrial Flutter/Fib, Corhythm, Intrapace, Mir A Imran (InCube), Neurolink, Obesity, Pain, Spinal Modulation

Mir A. Imran (born 1956, Hyderabad, India), is an Indian entrepreneur and venture capitalist. Imran has formed 19 companies since the early 80s and holds over 140 patents.  He is the founder and Chairman of InCube Laboratories, Inc., a research laboratory and business incubator for medical and technology companies

Currently, four InCube companies are focusing on active implantable medical devices:

  • Intrapace, which is developing an implantable device to treat obesity
  • Spinal Modulation, which is developing a novel therapy for the management of chronic pain with an implantable microstimulator
  • Neurolink, which is developing a novel therapy for epilepsy
  • Corhythm, which is focused on the treatment of AFIB