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 Product Summary

Home Monitoring


Best Pacemaker Defibrillato



All the pages below are in Vietnamese

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Contact: nwspi@ comcast
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lienlac@
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Simply the best
pacemaker and defibrillators
in Vietnam
2014


Actually our title should be more ambitious, namely "Simply the best pacemaker and defibrillators", with features that really help the patient, as opposed to features that makes good PR! We believe that the devices described in this section are the best in the world. The devices are

Biotronik Evia DR-T

Evia DR-T With a nominal longevity of 11.8 years with a full set of diagnostics, including 2 channels of intracardiac electrograms with 75% pre-arrhythmia trigger, and Home Monitoring ready (still need to purchase CardioMessenger to participate), the Evia DR-T offers the following features
  • MR conditional allowing full body MRI scanning when implanted with the appropriate leads
  • High capacity battery 1.2-1.3 Ah with high voltage (3.1 and 3.0V) yielding longevity of about 12 years.
  • CLS physiological rate adaptation. Exclusive feature from Biotornik. By evaluating the inotropic response of the heart, the Evia pacemaker can determine the exact pacing need of the heart. This is a Closed Loop System (CLS) incorporating the response of the body autonomic nervous system. This is the only rate adaptation program that has been recognized by the FDA that can respond to mental stress. Clinical studies have proven it effective against syncope  due to posture change (vasovagal reflex). Currently this is the only pacing mode that can reduce atrial fibrillation burden.
  • 20 intracardiac records, each 10 s long ... to help diagnose proper working of the device (timing of dual chamber pacemakers are sometimes unusual and need adjusting) with 7,5 s of pretrigger (to help understand how/why the device has an unusual behavior). 
  • Automatic amplitude adjustment of the pulses ... enhance device longevity. We have found that the predicted longevity of the device in patients usually exceeds the nominal longevity when these automatic amplitude adjustment programs are turned on.
    • Ventricle: with verification of capture after each pulse, and if needed a backup pulse to guarantee capture each heart cycle. Amplitude is just +0.5V above the pacing threshold. 
    • Atrium: daily verification, with amplitude just +1V above pacing threshold, the lowest margin in all devices
    • Selectable maximum adjustment amplitude. This is a feature available only in Biotronik devices. By choosing a lower amplitude the polarization artifacts can be minimized increasing the success rate of the automatic program. Other devices only have one maximum amplitude which may be overkill when the pacing threshold is low and is the cause of unsuccessful program activation yielding maximum pacing voltage while the pacing threshold can be low.
    • High safety. If for some reason, the automatic amplitude fails to operate properly, due to change in the patient conditions, the device will pace at +1.2V above the maximum amplitude. This means that we can provide pacing protection all the way to a pacing threshold of  6.0V, the highest level in all pacemakers.
  • Two ventricular pace reduction programs for patients with good atrio-ventricular conduction. Reduces heart failure caused by excessive ventricular pace, and increases device longevity.
    • IRS+. This is the main program. It is based on AV hysteresis that has the device waiting for 400 ms to allow the electrical pulse from the atrium to propagate down to the ventricle. This is similar to the program used in the INTRINSIC RV clinical study with ~ 50% reduction in heart failure when compared to backup pacing in patients with good conduction (the official result is that pacing with AV hysteresis is not inferior to backup pacing ... because the number of patients is not sufficient to definitely prove superiority). IRS+ is an improvement over the program used in INTRINSIC RV.
    • VpSuppression. For a minority of patients who do tolerate ventricular pacing well, the Evia also offers VpSuppression which is a program that switches between atrial pacing and dual chamber pacing. The percentage of ventricular pacing is even reduced further than with IRS+ and thus can achieve slightly better device longevity (a couple of months difference in the course of 12 years!), but in patient who can support ventricular pacing, the results of a clinical study using this type of ventricular pacing reduction was a worse heart failure rate than backup pacing. The clinical study was cancelled. Thus, we recommend that this be restricted to patients who do not tolerate ventricular pacing well.
  • Enhanced automaticity. A number of advanced features to ensure that the device works as it should
    • Automatic sensing threshold. This uses the automatic threshold that has been used successfully in defibrillators to guarantee sensing even when the signals varies significantly from heart cycle to heart cycle.
    • Automatic measurement of lead impedances both unipolar and bipolar every 30 seconds. Should a lead has a failure, this will be detected and appropriate action taken to guarantee continued performance. If Home Monitoring is active, an alert will be generated. In previous generation measurements were performed only when the lead is used for pacing. Thus a failure in an unpaced lead would not be noticed.
  • Home Monitoring ready. After signing up for Home Monitoring by purchasing a CardioMessenger unit, you can travel the world and your cardiologist will be alerted should the device not operate properly or you have an arrhythmia. An experienced clinical engineer with >20 year experience with Biotronik devices review the nightly follow-up (365/365) and will alert your cardiologist should it become necessary. You will enjoy the same type of follow-up care that Western patients enjoy.
    • The difference between the Evia DR-T and the Evia DR is that the former is Home Monitoring ready. All the other features are similar. The slightly shorter longevity is due to Home Monitoring. Without it, the 2 devices are expected to have the same longevity.
  • Reliable leads. Biotronik is the only pacemaker company not to have had a single lead recalled in its 50+ year history!

Biotronik Evia DR-T
Simply the best pacemaker system!

Please come back to this page in October 2014. We expect to have an update of this page at that time.

Biotronik Iforia 7 DR-T

Iforia 7 DRT This is the thinnest implantable cardioverter defibrillator (ICD) in Vietnam at 11 mm. With is 1,73 Ah battery, the nominal service life is 9.7 years with a full set of diagnostics, including Home Monitoring and storage of 3 channels of cardiac electrogram with pre-arrhythmia storage. Some competitors in their nominal service lives do not include any pacing (we do 15% in the atrium, 50% in the ventricle), pre-arrhythmia storage (can reduce longevity by up to 19%). Some of the features of the Iforia 7 DR-T:
Biotronik Iforia 7 DR-T,
Simply the best dual chamber ICD system!

Biotronik Iforia 7 VR-T DX

Iforia 7 VR-T DXThe Iforia 7 VR-T DX is the high-end dual chamber ICD that just requires a single lead, Linox smart ProMRI S DX. This single lead technology has been available exclusively from Biotronik for the past 13 years.
With its 1,73Ah battery, the Iforia 7 VR-T DX has a nominal service life of 10.5 years!
Except for not been able to pace in the atrium, and thus is appropriate only for patients with a good sinus node, the Iforia 7 VR-T DX system has exactly the same functionalities as the Iforia 7 DR-T above. Thus we will not repeat the features of the Iforia 7 VR-T DX here.
With a single lead, as opposed to a shock lead and an atrial lead, the Iforia 7 VR-T DX is easier to implant, and take up less space in the veins of the patient.
The 8F Linox smart S DX lead is pictured below.

Linxo smart ProMRI S DS

Chét x-ray S DX
Implanted DX system. A single lead for this dual chamber ICD!
Notice the 2 rings in the atrium.


Even though the Iforia 7 VR-T DX uses only 2 rings that do not need to contact the atrium, excellent atrial signals can be recorded.

VR-T DX sensing
3 channels of stored IEGM in the Iforia 7 VR-T DX.
Depicted is an episode of atrial flutter detected by the device but not treated.

Atral fibrillation
Episode of atrial fibrillation.
Initially cardiologists were concerned that a good atrial signal would not be possible during atrial fibrillation. Notice the varying amplitude, but the signal was adequate.

VT
Episode of ventricular tachycardia

The convenience of a single lead implant combined with the capabilities of a dual chamber ICD has made the DX line of ICDs a great hit in the US for new implants.

Biotronik Iforia 7 VR-T DX:
Implants like a single chamber ICD, performs like a dual chamber ICD.
Simply the best single lead dual chamber ICD system!


Medical tourism

If you are interesed in being implanted one the above devices, we can help you make all the arrangements. It will take approximately 2 weeks. Please feel free to contact us.
These Biotronik are covered by a worldwide warranty.




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You can contact us by e-mail at nwspi@comcast.net or lienlac@tamthuvn.com  . We will strive to answer your e-mail in English or French in the shortest time possible. Thank you for visiting this Northwest Signal Processing / Systolic web site.


Last updated:   8/12/2014                                                Copyright NWSPI 2008-2014