Biotronik Eluna Pacemaker System Given FDA Approval for MRI Full Body Scans

A brief note ... the FDA has given approval the patients implanted with the Biotronik Eluna pacemaker can safely undergo full MRI body scans. Note, this approval does NOT say that this pacemaker is MRI-safe. Someone implanted with this pacemaker cannot be placed in an MRI without making the necessary changes.

The pacemaker is MRI-conditional ... meaning that it is safe for a patient with a Biotronik Eluna pacemaker with the ProMRI technology to undergo a full-body MRI scan under the condition that the settings on this pacemaker are properly set to their MRI conditional settings.

... sometimes I worry that announcements like these can be misinterpreted and could lead to something bad happening. I've seen an article regarding a Biotronik pacemaker that stated that the pacemaker was "MRI-safe" when it wasn't true. As of this date and as far as I know, there are no MRI-safe pacemakers. The one's where the FDA has approved MRI compatibility are all MRI-conditional.

Here are links to two articles announcing FDA's approval:

http://www.businesswire.com/news/home/20150320005438/en/FDA-Approves-BIOTRONIK-Eluna-Pacemaker-System-Full-Body#.VQ0Cr1zDZZU

http://www.dotmed.com/news/story/25371

How This Blog Got Going: MRI Safe and Conditional Pacemakers, Reprise

I have decided to return to the thing that I was working on when I started this blog ... an MRI conditional pacemaker. Specifically, an MRI conditional pacemaker for St. Jude Medical. At the time I was Lead Human Engineering Clinical Systems Engineer on this project. Before I go any further I would like to distinguish between MRI conditional and MRI safe devices. It is important to distinguish between the two.

MRI Conditional v. MRI Safe

Having an MRI safe implanted cardiac device is the ideal situation. If the cardiac device is MRI safe, it means that a device patient can be "popped" into an MRI without any changes to the device. For the patient it's just like the person does not have an implanted device. The only difference is that the resulting imagery from the MRI around the device may not be as good if the person did not have an implanted device. 

An MRI conditional device presents some significant procedural challenges to all those involved. If a person has an MRI conditional device, certain conditions must be met before the device patient is allowed to enter the MRI. When I was working at St. Jude Medical, changes in the settings that operate the device are required before the patient enters the MRI. Once scanning is complete, the settings need to be changed back to their normal, operational settings.

As of publication of this article, only one medical device company has a commercially available MRI safe pacemaker, Biotronik. St. Jude Medical and Medtronic have commercially available MRI conditional devices. 

When I was work at St. Jude, the only cardiac device being engineered to permit patients to have MRI scans were pacemakers. At the time ICDs and CRTs were not considered for MRI compatibility. However, apparently, Biotronik has developed an MRI conditional ICD that is commercially available ... at least in Europe.

There are other issues regarding MRI compatibility such as whether there are limits on the area that can be scanned a cardiac device patient ... something other than a full body scan. The allowable limits on how much can be scanned are continually in flux. But this particularly issue does not have anything to with the story I want to tell.

My Experience with the MRI Conditional Project

The St. Jude Medical MRI conditional pacemaker was engineered to enable patients to undergo an MRI scan. To insure that pacemaker patients would not be harmed by the scan required that the operating settings on the pacemaker be adjusted. (To make a long story short ... a change in the setting needed to make sure that the sensing lead to heart be turned off. The pacemaker could be changed to constant pace or turned off entirely if the patient is not pacemaker dependent ... as most pacemaker patients are.)

So the major problem in this entire issue was in regards to how to change the settings on the device? Who would do it, how would it be done, what would the settings be? Essentially three basic approaches were considered:

1. Have the patient's cardiac physician or cardiac nurse go to the MRI center, lugging their device programmer with them, change the settings on the patient's device to those that are MRI compatible, wait for the scan to complete, reset the settings to normal and examine the patient to insure that the patient is OK.
2. Have the settings changed remotely. The patient is at the MRI center, the cardiac professional is in the office, at the hospital or at home. This is known as "remote programming."  At the time this was something that the FDA did not allow. Using remote programming, the patient's device communicates wireless to a pacemaker communicator located at the MRI center. The cardiac professional sees a 30 second rhythm strip before setting the patient's device to the MRI settings and sees another 30 second rhythm strip after the changes have been made. (Just like an onsite cardiac professional would do.) The patient undergoes the scan. During that time, the professional can perform other tasks. Once the scan is complete, the cardiac profession changes the pacemaker settings back to normal and sees the before and after rhythm strips. 
3. The pacemaker is programmed with two settings by the cardiac professional using the programmer. The first set of settings define the normal operation of the pacemaker. The second set are the MRI settings: that is, the settings of the pacemaker when the patient undergoes an MRI scan.  When the pacemaker patient goes to the MRI center, the MRI tech takes a wand (that's best way I can describe it.) and changes the settings from normal to MRI. Once the patient completes the MRI scan, the MRI tech uses the wand to change the patient's setting back to normal. 

I became quickly apparent that cardiac professionals had no interest in option 1. As it turned out St. Jude Medical chose the third approach. 

When the third approach was described, I had numerous objections ... mostly related to the device that would change the setting on the pacemaker. Thankfully, there have been substantial changes and upgrades made to the wand. However, I wanted to purse option 2, remote programming. And the desire to purse option 2 inspired me to start this blog ... hence the title Medical Monitoring & Remote Programming.

Wherefore Remote Programming?

Most physicians showed some hesitancy when it came to adopting remote programming. They saw it as unproven ... and they were right, it was (and so far as I know still is) unproven and still not acceptable to the FDA. However, many if not most were intrigued by the idea and thought that the technology should be pursued. Many clearly saw the potential value of the technology, the value of being able to monitor patients remotely with the potential ability to change cardiac device settings without the patient being in the office could be a revolution in patient care ... not only for people with chronic conditions like heart problems, diabetes or neurological problems that involve implanted devices, but potentially everyone. And it need not involve the need for implanted or wearable devices. We'll explore this in later postings.

Medtronic Remote Monitoring Study: CONNECT

At the American College of Cardiology 59th annual conference George H. Crossley, MD presented evidence that cardiac patient from remote monitoring (one scheduled in-office visit per year with remote monitoring) verses standard in-office care (four in-office visits per year) cuts the time between the time a cardiac or device related event occurs and when a treatment decision is made.

The title of the study: "The clinical evaluation of the remote notification to reduce time to clinical decision (CONNECT) Trial: The value of remote monitoring."

I present a summary of the method and the results of the study gleaned from the slides presented by Dr. Crossley at the conference.

Hypothesis

Tested hypothesis: Remote monitoring with automatic clinician notifications reduces the time from a cardiac or device event to a clinical decision.

Additionally investigated were rates utilization of the health care system including hospitalization and between treatment groups.

Method

Study participants:  1997 newly implanted CRT-D and DR-ICD patients from 136 US centers were randomly assigned to one of two groups. The first group had 1014 patients assigned to the remotely monitored group and the second had 983 patients assigned to the standard in-office care group. The patients were reasonably well matched for age and gender characteristics.  (A procedure similar to the Biotronik TRUST studies.)

The patients were followed for 12 months.  (On first reading, I found the the time relatively short in that I would not expect enough differentiating events would occur during that time.  However, on further reading, I believe my first impression was incorrect.)

Findings

Time from Event to Clinical Decision

The median time (used nonparametric inferential statistics for the analysis) from the cardiac or device event to clinical decision was 4.6 days in the remote group and 22 days in the in office group. This difference was significant.  The remote group involved 172 patient while the in-office group involved 145 patients.

The cardiac/device events included:

• Atrial Tachycardia/Fibrillation (AT/AF) for 12 hours or more
• Fast Ventricular rate. Of at least 120 beats per minute during at least a 6 hour AT/AFT event
• At least two shocks delivered in an episode
• Lead impedance out of range
• All therapies in a specific zone were exhausted for an episode
• Ventricular Fibrillation detection/therapy off
• Low battery

Total number of events Remote group: 575 and In-office group: 391.  The slides show the breakdowns.

Office Visits

The number of office visits per patient reported are shown below.

                        Scheduled     Unscheduled      All office

Remote group:     1.68              2.24              3.92

In-office group:    4.33              1.94              6.27

The TRUST studies showed a slight increase of more unscheduled visits for the remote group. However, given the nature of the study and that remotely monitored patients would receive only one in-office visit per year, it's remarkable how similar the numbers between the two groups are.

Utilization of the Health Care System

Number of incidents where patients used the health care system show virtually no difference, hospitalization or emergency room. 

However, a remarkable difference was the significant difference in length of stay when there was a hospitalization. The remote group had a mean hospital stay of 3.3 days while the in-office group was 4.0 days with an estimated savings per hospitalization of $1659.

Conclusion

The CONNECT and (Biotronik) TRUST studies show clear benefits from a number of standpoints for remote monitoring.  In addition, the CONNECT study showed clear cost and hospital resource utilization benefits from remote monitoring in that hospitalized patients had shorter stays indicating that they were in better shape than patients in the in-office group when admitted to the hospital.  Quick responses seem to lead to better outcomes as well as cost reductions.

Here is the link to Medtronic's press release of the study: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1268659150410&lang=en_US

Here is another link to an article on the study that includes a link to Dr. Crossley's slides: http://www.cmio.net/index.php?option=com_articles&view=article&id=21235:acc-remote-monitoring-shortens-event-response-time-reduces-hospital-costs

Additional resources

Reimbursement for Remote Patient Monitoring in the United States- Regulatory Antennae Picking Up Demand Signals 

Remote ICD monitoring speeds diagnosis of arrhythmias.(CARDIOVASCULAR MEDICINE)(implantable cardioverter defibrillators)(Report): An article from: Internal Medicine News

Biotronik TRUST Studies: Reprinted Abstracts and Commentary

What follows are published abstracts of the Biotronik studies that provided evidence that Home Monitoring can substitute for quarterly check-ups for ICD patients.  That care of ICD patients can be just as effective with one per year in-clinic check-ups instead of the normal three month in-clinic check-ups.  This was supported primarily by 2008 study.

The 2009 study is a logical follow-up to the 2008 study. This study provided evidence that the Biotronik remote monitoring (Home Monitoring) system can provide early-warning notifications of significant cardiac events faster and more effectively than quarterly, in-clinic visits.  This study has wider implications.   It provides evidence that remote monitoring can provide the kind of care that at one time could only be provided in hospitals.  Furthermore, it demonstrates the kind of capability necessary to provide the kind of early warning that can keep specific, targeted populations out of hospital, thus providing more economical and more desirable health care.

These studies are reprinted with permission from Biotronik.  (I have no affiliation with Biotronik.) 


2008 Study


Evaluation of Efficacy and Safety of Remote Monitoring for ICD Follow-Up:

The TRUST Trial

Authors: Niraj Varma, Cleveland Clinic, Cleveland, OH; Andrew Epstein UAB Medical Center, Birmingham, AL; , Univ of Alabama Birmingham Medical Center, Birmingham, AL; Robert Schweikert Cleveland Clinic, Cleveland, OH; , Akron Medical Center, Akron, OH; Charles Love, Davis Heart and Lung Research Institute, Columbus, OH; Jay Shah, Carolina Cardiology Associates, Rock Hill, SC; Anand Irimpen; Tulane University Medical Center, New Orleans, LA

Background: Remote monitoring (RM) of ICDs may provide daily, automatic device and patient status data and cardiac event notifications. TRUST tested the hypothesis that RM was safe and effective for ICD follow-up for 1 year in a prospective, randomized controlled clinical trial.

Methods: 1282 patients were randomized 2:1 to RM or to conventional (RM disabled) groups.Follow up checks occurred at 3, 6, 9, 12 and 15 months post-implant. In the RM arm, RM was used before office visits (OVs) at 3 and 15 months. At 6, 9 and 12 months, RM only was used but followed by OVs if necessary. Conventional patients were evaluated with OVs only. Follow up was “actionable” if system reprogramming/revision or change in anti-arrhythmic therapy occurred. Scheduled and unscheduled OVs (including responses to event notifications in RM) were quantified for each individual patient per year (pt yr) of follow up. Incidence of death, strokes and surgical interventions (morbidity) was tracked in both groups. 

Results: RM and conventional patients were similar in age (63.3 ± 12.9 vs 64.1 ± 12.0 yrs, p = 0.30), gender (71.9% vs 72.4% male, p =; 0.89), pathology (LVEF 29.1 ± 10.8% vs 28.6 ± 9.8%, p = 0.47;coronary artery disease 64.5% vs 71.4%, p = 0.02), medications (Beta blockers 79.5% vs 75.9%, ACE inhibitors 42.4% vs 46.8%, ARBs 7.8% vs 9.9%, p = NS), indication (primary prevention 72.3% vs 74.2%, p = 0.50), and dual chamber implants (57.9% vs 57.0%, p = 0.76). RM reduced scheduled OVs by 54% and total OVs by 42% without affecting morbidity. Event notifications were managed using RM alone in 92% of cases. Of the remainder resulting in unscheduled OVs, 52.2% were actionable. RM improved adherence to follow-up. 

Conclusions: TRUST demonstrated that remote monitoring is safe, decreases the need for in-office visits, provides early detection of significant problems, and improves ICD surveillance without increasing unscheduled office visits. In conclusion, remote monitoring is a safe alternative to conventional care.


2009 Study


EARLY DETECTION OF ICD EVENTS USING REMOTE
MONITORING: THE TRUST TRIAL
 
Authors: Niraj Varma, MD, FRCP, Andrew Epstein, MD, Anand Irimpen, MD, Robert Schweikert, MD, Jay Shah, MD, Lori Gibson, DVM and Charles Love, MD. Cleveland Clinic, Cleveland, OH, University of Alabama Birmingham Medical Center, Birmingham, AL, Tulane University Medical Center, New Orleans, LA, Akron Medical Center, Akron, OH, Carolina Cardiology, Rock Hill, SC, Biotronik, Inc., Lake Oswego, OR, Davis Heart & Lung Research Institute, Columbus, OH

Introduction: ICDs have extensive self-monitoring capability with diagnostic data available at interrogation. Remote Monitoring (RM) may facilitate data access but this has not been tested. The secondary endpoint of the TRUST trial tested the hypothesis that RM with automatic daily surveillance can provide rapid notification thereby facilitating prompt physician evaluation.

Methods: 1312 patients were randomized 2:1 to RM or to conventional (C) groups. Follow up checks occurred at 3, 6, 9, 12 and 15 months post-implant. RM was used before office visits (OVs) at 3 and 15 months in RM group. At 6, 9 and 12 months, RM only was used but followed by OVs if necessary. C patients were evaluated with OVs only. Unscheduled checks between these time points were tracked. The hypothesis was tested by determining time elapsed from first event occurrence in each patient to physician evaluation.

Results: RM and C patients were similar (age 63 ±13 vs 64 ±12 yrs; gender 72 vs 73% male, NYHA class II 56 vs 61%, pathology LVEF 29 ±11 vs 28 ± 10%; CAD 65 vs 72%, amiodarone 14 vs 14%, primary prevention indication 72 vs 74%, and DDD implants 58 vs 57%). Median time to evaluation was < 3 days in RM compared to < 30 days in C (p < 0.001) for all arrhythmic events (figure) including silent episodes eg AF. System (lead/ generator) problems were infrequent (20 events in RM +C).

Conclusions: Remote monitoring with automatic daily surveillance provides rapid detection and notification of both symptomatic and asymptomatic arrhythmic events, enabling early physician evaluation.

Commentary

2008 Study


Of significant interest would be morbidity rate.  The remote monitoring group showed a .9% higher death rate than the conventional group.  This result was also nonsignificant.  The nonsignificant difference appears to be expected outcome.  Demonstrating a negative - or no difference - is always a concern in research because of the logical problem in demonstrating that something did not happen or that there are no difference between the groups.


I have an additional concern with respect to the unbalanced design.  Unbalanced designs have lower  power of your statistical power - that is, the ability to reject the null hypothesis - than balanced designs. And that would be of concern in study where the expected outcome is no difference.  However, the numbers are extremely large that should off-set the reduction in statistical power created by the unbalanced design.  Since I do not have the raw data, I cannot be sure.  Nevertheless, this seems reasonable. 


The remote monitoring group did have a slightly higher rate of unscheduled appointments - .6 per year in the RM group and .5 in the conventional group; and the actionable percentage was .7% higher in the RM group. The differences could be considered marginally significant with a p = .104. If I understand the circumstances correctly, it seems reasonable that remotely monitored patients would have a higher rate of unscheduled appointments.  Remote monitoring should have the capability of earlier detection of arrhythmic events.  Thus a detected cardiac event would trigger the patient's to request that the patient come to the clinic as soon as possible thus an unscheduled appointment would be registered.  One might expect remotely monitored patients would have appointments that are more demand or situation based than regular, scheduled appointments.




In spite of this difficulties of this design, the conclusions of this study seem reasonable in that the remotely monitored patients who received in-clinic check-ups once per year had similar outcomes to those who receives conventional care with four in-clinic visits per year.


A point of interest.  No comparisons were made between Biotronik and remote monitoring systems provided by other companies such as Medtronic, St. Jude Medical or Boston Scientific. I understand the difficulties and roadblocks in the attempt to assess whether the other systems would be just as effective.  However, Biotronik effectively side-stepped the issue by comparing their home monitoring system against conventional care thus avoiding comparisons with other remote monitoring systems.  Biotronik focused on effectiveness against conventional care and in this case they were successful.


2009 Study

As a study to show the effectiveness of remote monitoring, I believe this study is more effective.  First, it's a better design in that the expected outcome is to reject the null hypothesis - that is, to find a significant difference.  Second, there is a clear case made by the findings that remote monitoring leads to earlier discovery of an adverse event.  One truism in medicine, particularly when it comes to cardiac events, is the earlier the discovery, the better the outcome.  Another thing, ICD patients have been identified as a vulnerable population and rapid reports of adverse events within this population are particularly welcome.


In theory, over time patients remotely monitored should show better outcomes than those who are not.  The data in these two studies does not show that.  However, data from other studies are starting to demonstrate that remotely monitored patients are less likely to be admitted to the hospital.  This is a new area of technology and more research is required.  However, the trends are favorable for remote monitoring.


In this study, the Biotronik remote monitoring system reported arrhythmic events.  The data reported was not early warning or predictive.  The capability to collect predictive data would increase the value of remote monitoring.  Predictive data would allow the clinic (or computer system) following the patient to intervene before the adverse event occurs.  In this study, this was not the case.

Biotronik Home Monitoring: Update

Biotronik Home Monitoring recently received the industry's first European CE Mark.  Here is the link to one of the publications that announced this: Biotronik Home Monitoring Receive Industry Approval.  The approval appears to be founded on the studies conducted by Varma that are referenced in the article.  I hope to have more information on this subject in the near future.

Biotronik Home Monitoring Claim

I'm posting this article before my discussion on measurement and sensing because it has relevance to my immediately preceding posting.  

Biotronik released to the press on Tuesday 27 October 2009 an announcement regarding their Evia Pacemaker.  In that press release was some additional information regarding Biotronik's Home Monitoring system.  Here's the link to the press release: http://www.earthtimes.org/articles/show/biotronik-launches-evia-pacemaker-series,1016041.shtml

The relevant quote from the press release is the following:

Now physicians have the choice to call in their patients to the clinic or perform remote follow-ups with complete access to all pertinent patient and device information, including high quality IEGM Online HD^®. Importantly, BIOTRONIK Home Monitoring^® has also received FDA and CE Mark approval for its early detection monitoring technology which allows clinicians to access their patients’ clinically relevant event data more quickly so they can make immediate therapy decisions to improve patient care. 


The indications are that the Biotronik claims that their system provides quicker access to relevant data, not that the data (and analysis) yield earlier warning results.  This is consistent with my earlier analysis and that seems to be supported by Biotronik's own admission.

I do wonder about Biotronik's long-term objective.  I suspect that Biotronik wants to be one of the big three implantable device manufacturers, not just become one of four.  It would mean that Biotronik would likely target one of the big three to replace and that would likely involve targeting the weaknesses of the company that Biotronik wants to replace.  I'll continue to monitor Biotronik and report what I find.



Next, my discussion on measurement and detection.

Remote Monitoring: Deep Dive Introduction

I am going to change course over the next few entries to focus on remote monitoring.  This article is the first in a series of articles on Remote Monitoring and what can be gleaned from the data remote monitoring collects.  The Biotronik press releases and some of the claims they have been making have driven me to investigate and speculate on remote monitoring, its capabilities, potential and possible future. 


Two claims that Biotronik have made for it's Home Monitoring system have intrigued me.  First, Biotronik claims as a proven capability of earlier detection than other systems of critical, arrhythmic events.  Second, they also claim that they can report these events earlier than other systems.  

Let's take the second claim first, Biotronik has created a system with the capability to more quickly notify (e. g., transmit) implant data.  The Biotronik mobile capability enables a faster detection and quicker transmission of those events by virtue of its mobile capability.  Their claim is rooted in mobility of their monitor and its communication system.  So, the second claim appears plausible.

The first claim is more difficult not only because it is more difficult to prove, but because it's more difficult to define.  I think of at least two ways the capability could be defined and implemented.  One, consider the signal-detection paradigm.  I have a drawing that defines the basic signal detection paradigm below.

 

The basic concept of signal detection is extraordinarily simple.  On any given trial, a signal is either present or not.  It is the job of the detector to accurately determine whether or not the signal is present.  There are two right answers and two wrong answers as shown in the diagram.  The type 1 error is the indication by the detector that is signal is present when it is not.  (The probability of a type 1 error is represented by Greek letter alpha.)  The type 2 error is incorrectly indicating that a signal is not present when in fact it is.  (The probability of a type 2 error is represented by Greek letter beta.)


The objective of detector improvement is to reduce both type 1 and 2 errors.  However, often times adjustments are made to alpha or beta to make it look like there's an improvement.  For example, if sensitivity is the crucial characteristic, the engineers may be willing to sacrifice an increase in type 1 errors to reduce type 2.  (This gets into what's called receiver operating characteristics or ROC.  Something for a later blog article.)


I discuss the signal detection paradigm for two reasons.  First, the signal detection paradigm is an engineering and scientific touchstone that I'll refer to in later articles.  Second, it allows one to assess just what is accurate detection, increasing sensitivity, etc. 

Thus Biotronik's claim of earlier detection could be real or it could reflect Biotronik's acceptance of more type 1 errors in order to raise sensitivity.  This could lead to earlier detection but at the expense of increasing the likelihood of type 1 errors. In the next article, I'll explore ways to improve detection capabilities, not by increasing accuracy of a particular detector, but by increasing the number of different detectors.



Early detection could also be interpreted as predictive.  This is the more difficult than simple detection.  This would be the computed likelihood of a particular event based on one or more measurements.  This does not fit into the simple signal detection paradigm.  It often involves finding a pattern and extrapolation.  Or it could involve finding a predecessor indicator; finding a condition that is a know precondition to the target.  The specifics of a predictive capability will be discussed in a later article.  


This ends the Introduction.  The next article will discuss detection capabilities in greater detail.

Biotronik Home Monitoring Operational in Europe

I've mentioned Biotronik's Home Monitoring system in an earlier post.  One of the attractive things about the Biotronik version is that their home monitoring has been deemed a replacement for clinic visits.  Quote from the article (link immediately below)

Biotronik Home Monitoring Goes Live in Europe

"Designed to avoid regular visits to the clinic by patients wearing company's ICD's, CRT's, and similar devices, the system sends readings from the chest straight to your doc over the cellular phone network."

This is an interesting development because Biotronik has been taking market share from the big three medical device makers.  I think that the Biotronik capability reduce clinic visits translates into either more revenue or more free time.  Either one would be attractive for device managing physicians who may suggest to implanting physicians to choose Biotronik.  This may be a situation where a robust home monitoring system drives the choice of the brand of device to implant.  I do not have clear evidence, but I think the issue is worth investigating.


Three aspects of the Biotronik home monitoring system seem to differentiate it from others.  First, the monitoring unit is mobile and uses the GSM to communicate with the monitoring servers.  The monitoring servers in turn can notify the device managing physician or clinic with an email, SMS (text) message or fax.  Second, Biotronik home monitoring unit has what they call an intelligent traffic light system.  I haven't any information on how the intelligent traffic light system operates.  Finally, and I think most importantly, the Biotronik system has the capability of earlier detection than other systems of critical, arrhythmic events.  They claim that this is a "proven capability."  Since I have no information on the operational details or algorithms that they use, I cannot confirm or deny their claims.  


The German Government has shown its belief in the bright future of Biotronik and its Home Monitoring technology: Nominated for the German Federal President`s "Deutscher Zukunftspreis" (German Future Award): BIOTRONIK Home Monitoring for Online Monitoring of Heart Patients.

Update: 21 October 2009.  A little more information about the research the Biotronik performed with respect to the value and capabilities of their Home Monitoring system.


Biotronik Press Release Published in Reuters Regarding Home Monitoring.  This press release mentions three publications of the results of the Biotronik study.  I have not yet been able to obtain a copy.  From the outside, it's hard to assess of the significance of the technology or technologies that Biotronik has incorporated into their system. However, from the outside, it appears that with the possible exception of the mobile monitoring unit, it looks more like a publicity campaign than substance because there is nothing that I can see that clearly sets Biotronik's remote monitoring system from anyone else with respect to data collection and/or analysis.