Product summary

NASPE/BPEG code for pacemakers.
Typically only the first 4 letters are used. The fifth letter is only used in the case of triple chamber devices, see CRT.

The pacemakers below are safe for MRI scanning. They do require that the device be programmed to a safe program prior to the scan, and then reprogrammed back to the original program. These are the MR conditional pacemakers. This is the future trend for pacemaker. It is estimated that a person being implanted today with a pacemaker will likely need to undergo an MRI scan during the life of the pacemaker. Without it being MR conditional, an MRI scan may be refused, depriving the patient from a life saving diagnostic!


• ProMRI Evia DR (DDDR). This the premium pacemaker from Biotronik with its unique CLS physiologic rate response that gives the patient a "normal" heart rate (all the other devices use an accelerometer to determine your heart rate, which is non-physiologic). When used with a ProMRI lead, it is an MR conditional pacemaker system. News features include: atrial autocapture, automatic sensitivity (like in defibrillators), two algorithms to reduce ventricular pacing, namely IRS+ and Vp Suppression, Program Consult (for 10 default program sets), Easy AV (to simplify programming AV delay and AV hysteresis), >12 years service life.
• ProMRI Estella DR (DDDR). Almost everything in the Evia, minus CLS. MR conditional, >12 years service life. The affordable MR conditional DR.
• ProMRI Estella SR (AAIR/VVIR). MR conditional, >15 years service life. The affordable MR conditional VR. 
  
  
• Effecta D (DDD). All the automation in the Estella DR, >12 years service life.
• Effecta S (AAI/VVI). >15 years service life. 

For MRI scanning, the whole system (pacemaker and lead) must be MR conditional. See below. Why is MR conditional important. Below is a graph illustrating the increased need for MRI diagnostics with increased age. Since implanting a non MR conditional may be a verdict for the remaining life of no-MRI (a non-MRI conditional lead in the body = no MRI), it is of the utmost importance that only MR conditional systems be implanted.

MRI needs. From a Boston Scientific webpage on MRI.

For a young patient, the selection of a high quality lead may be even more critical than that of the pacemaker. We offer one of industry's best longevity lead. While a pacemaker service life is 7-15 years, depending on how it operates, a high quality pacing lead can last 2 to 3 times as long. This is important since most cardiologists will leave the lead in the body should it become defective, clogging the vein of the patient. The cumulative survival rate of the Polyrox lead that we have been selling in Vietnam for a number of years is shown in the graph below. None of the competing leads in Vietnam can boast such survival rate.

Polyrox survival probability.
Extract from Biotronik performance reports.

The newer lead family in use right now are

• Setrox S. This is a very flexible lead that bends when the heart contract. It is well suited for the latest implant technique of implanting leads in the ventricular septum. It uses a 7 French introducer (1 French = 0.33mm).

As with all Biotronik leads, the electrodes have an Iridium fractal coating to increase the interface surface area to yield excellent signals. With the large signals achiveable,   the surface areas of the electrodes can be decreased to achieve low pacing thresholds and high impedances, desirable pacing characteristics. This electrode surface treatment is available only on Biotronik electrodes. Such a surface treatment makes Biotronik leads ideally suited for the automatic amplitude control algorithm used in newer generation pacemakers.

• Siello S, T and JT. This is the latest generation of leads which require 6 French introducers. In spite of its smaller diameter, the insulation thickness of the Siello lead is the same as the one of the Setrox lead and the bigger Selox SR lead, thus ensuring that this is a safe lead resistant to wear and tear.

The MR conditional leads are the Safio S (7F) and Solia S (6F) and Solia T (6F) which are externally and handling-wise similar to the Setrox and Siello leads.

So, why not use the best?

Implantable cardioverter-defibrillator

ICDs are devices used to treat patients with life threatening fast heart rate, namely ventricular fibrillation. We offer the following products:

Implantable cardioverter defibrillators
	Single chamber	Dual chamber	Single lead dual chamber	Triple chamber for Congestive Heart Failure Therapy
Iforia 3, 11 mm thin
	Iforia 3 VR-T 10,1 years	Iforia 3 DR-T 9,0 years		Iforia 3 HF-T 6,6 years
Devices below are MR conditional (can have MRI)
Iforia 5, 11 mm thin
	Iforia 5 VR-T 10,1 years	Iforia 5 DR-T  9,0 years	Iforia 5 VR-T DX,  9,2 years	Iforia 5 HF-T  6,6 years
Iforia 7, 11 mm thin
	Iforia 7 VR-T 11,5 years	Iforia 7 DR-T 10,2 years	Iforia 7 VR-T DX,  10,5 years	Iforia 7 HF-T 7,5 years

All the above devices provide ventricular tachyarrhythmia (fast heart rhythm) therapy and either single, dual or triple chamber bradycardia (slow heart rate, see pacemaker above) therapy.

The main device is the Iforia 3 VR-T with a 1,52 Ah battery, larger than most competitors.  The Ifforia 3 DR-T is the dual chamber ICD. The Iforia 3 HF-T is the  triple chamber ICD, the CRT-D. These devices unfortunately have a contraindications for MRI, that is you cannot have an MRI once you have them in your body. This is a common problem with all ICDs until recently.

Our premium devices are the Iforia 5 and 7 ICDs  which are MR conditional when used with MR conditional leads, namely the Linox smart ProMRI SD or Protego ProMRI SD shock lead and the Safio and Solia leads (see above). Both Iforia 5 and 7 devices offer essentially the saem functionality but the Iforia 7 ICDs have 1,73 Ah batteries, the largest available, and excellent longevity.

For ICDs in the same generation, i.e. the year of product introduction, Biotronik ICDs lead others in the following

• Thickness. Biotronik are typically thinner than others, only 11 mm.
• ATP-One-Shot therapy for the fastest rate lethal ventricular arrythmia, ventricular fibrillation. If the rhythm is stable, the device will deliver a painless bursts of pacing and immediately start charging for a shock. In clinical studies, ATP-One-Shot is successful in breaking over 2/3 of these episodes of very rapid arrhythmia which in previous generations of defibrillators would have been treated with painful shocks. According to the studies done by Dr Sweeney, ATP-One-Shot can decrease your risk, since patients who receive shocks tend to have a shorter life than those who don't.
• The largest memory available for storing electrograms. This is a key diagnostic capability. 30 s of pre-episode electrogram can help your cardiologist adjust your medication to prevent recurrence of the tachyarrhythmia episode. Length of electrogram helps understand the progression of the arrhythmia during therapy progress and again helps your cardiologist adjust the ICD parameters for optimal and less painful therapy.
• Number of channels. VR-T DX, DR, HF-T: 3 channels. All other: 2 channels.
• Duration: 24 minutes;
• Pre-storage: up to 30 s;

In general dual chamber devices are implanted because either the patient requires pacing due to slow heart rate or because the patient has episodes of ventricular tachycardia (an organized high rate ventricular rhythm that reduces blood circulation and thus requires therapy). A single chamber device has a high probability of misdiagnosing a supraventricular (above the ventricle) tachyarrhythmia, which normally does not require therapy because it is typically not life threatening, for an episode of ventricular tachycardia leading to therapy being delivered in the ventricle causing pain and possibly generating an episode of ventricular tachycardia or ventricular fibrillation. All the Biotronik dual and triple chamber ICDs use the SMART Detection discrimination algorithm to prevent inappropriate therapy from being delivered. This algorithm was developed by Dr. Tran Thong, the founder of Northwest and Systolic, and his engineers at Biotronik, and is currently the best discrimination algorithm with sensitivity (ability to detect a ventricular tachyarrhythmia) of 100%, and a specificity (ability to hold off therapy when not a ventricular tachyarrhythmia) of 93-97%. A single chamber ICD typically has specificity in the 50-75% range, thus delivers a lot of inappropriate therapies, especially painful shocks, in patients with ventricular tachycardia! This is one of the reasons why over half of the ICD implants in the US are dual chamber devices! In the recent report on the ALTITUDE study, shock therapy of atrial fibrillation can increase your mortality risk by 61%, when compared to no shock. Thus, you owe it to yourself to have the best discrimination algorithm in your dual chamber defibrillator.

Smart Detection diagram. Simple but very effective!

For patients who require pacing, we highly recommend the dual chamber Biotronik defibrillators above. All the Biotronik dual chamber pacemakers and defibrillators support the IRS+ algorithm for reduced ventricular pacing. This is similar to the algorithm used in the INTRINSIC RV clinical study which showed that dual chamber pacing with an algorithm similar to IRS+ to reduce ventricular pacing can actually reduce incidences of heart failure. In Vietnam, the reduction demonstrated in INTRINSIC RV can only be achieved with Biotronik dual chamber devices. The ventricular pace reduction algorithm used in all the competing devices are different from the one in this study!

The original shock lead used with our devices, the Kentrox SL, has an excellent survival record, still unmatched by its competitor.

Kentrox SL survival probability.
Extract from Biotronik performance reports.

Linox smart and Protego shock leads with screw fixation.
We can also offer the same leads with a passive fixation.
And we can also offer the ProMRI, MRI conditional,
versions of all the screw fixation shock leads.

Linox smart and Protego shock leads are the successors to the Kentrox.  Requiring only an 8 French introducer, this is an extremely flexible lead with a soft lead tip designed to minimized dammage to the heart, a problem that has plagged other leads. To help cardiologists, the leads also has a smooth surface, SilGlide, formed by plasma heating the silicone insultaion.
With its flat wire technology (ProTek) to minimize fibrosis, the lead can be removed more easily should this become necessary at some time in the future. It also has one of the thickest insulation making it the safest lead in the industry. 

Linox very flexible lead allows it to flex with each heart beat and not dammage the heart.

Linox soft tip reduces pressure on the heart. It also help speed implant since the cardiologist can make pacing measurements prior to deploying the screw.

Protek design of all Biotronik shock leads (already in Kentrox) increases energy delivery and minimizes fibrosis, simplifying lead removal should this become necessary.

Insulation thickness. The lead on the right has been recalled due to wire break and the company is now supplying a much thicker lead. The lead on the left is no longer sold due to insulation wear both from the outside and more seriously from the inside.

Why play Russian roulette with your defibrillation lead. Use the one that has been the safest!

Home Monitoring

A new feature which has become available in Vietnam since mid 2011 is the Biotronik Home Monitoring. In all of Southeast Asia, you can get Home Monitoring (HM) only from Systolic Medical. All the Lumax family of defibrillator are HM enabled. You will need to buy a CardioMessenger (see picture above), a dedicated cellular phone that relays message from your defibrillator to the monitoring center in Germany. Each night the defibrillator transmit a full report of the functioning of the device to the center. This is made available on the internet to the monitor engineer of Systolic Medical, with >19 years of experience with Biotronik defibrillators. He will monitor everyday and if an event, that you, the patient, may not even be aware of, happens, he will be in contact with your designated cardiologist for a more detailed followup. An example of a patient with a history of significant arrhythmia that has been successfully treated is available at this website. The page is in Vietnamese, but just looking at the top graph, you can understand how successful it has been. An another example is of predicting an imminent episode of heart failure decompression, saving the patient from a hospital stay.
For non-Vietnamese patients, a defibrillator with Home Monitoring is ideal. If you have been implanted a Biotronik defibrillator in Southeast Asia, and Home Monitoring is not available in your home country, you can come to Vietnam and we will be glad to set you up with it. As you are monitored, if an event is reported, your personal cardiologist in your home country can be informed with recommendation about what changes in programming would be required. If interested, please contact us at nwspi@comcast.net.
Home Monitoring just requires that at home you have access to a 3G cellular network. Actually you need only the GPRS capability of a 2.5G network. If you have an iPhone and can surf the net, Home Monitoring will work.

We now have a webpage dedicated to Home Monitoring.

Cardiac Resynchronization therapy

Evia HF-T	Iforia 3 HF-T	Iforia 5 HF-T	Iforia 7 HF-T

The Evia HF-T is a full featured triple chamber pacemaker, and the only MR conditional in the world at this time (August 2012). The  Ioria 3/5/7 HF-T are a triple chamber ICDs. They all offer the following key features

• RV triggered pacing. When a right ventricular R wave is sensed, a left ventricular pulse is triggered. The right ventricular pulse is inhibited, saving battery.
• With the Evia HF-T the cardiologist has the ability to select6 LV pacing vectors, 5 with the Iforias. This enables the cardiologist to electronically reposition the LV lead to try to avoid high pacing threshold, phrenic nerve stimulation (hiccup). This particular feature has enabled us to successfully treat a patient.

The Evia HF-T is the latest device from Biotronik. It is a triple chamber pacemaker that is MR conditional when used with MR conditional leads, namely the Corox ProMRI OTW and Corox ProMRI OTW-S (outwardly identical to the Corox OTW and Corox OTW-S described below) and the Safio and Solia leads. It has a number of very attractive features

• first and foremost is the physiological rate adaptation CLS. The only rate adaptation that just increases the heart rate in response to the body's hemodynamic needs, whether physical or mental! CLS has also been shown to reduce the atrial fibrillation burden (the time in AF). and can be used to overcome fainting due to position change (vasovagal syncope).
• To optimize its longevity, it offers automatic adaptation of the pacing voltages in all 3 chambers of the heart. Estimated longevity is 8.8 years
• Implanting a left ventricular lead is a most challenging task for the implanting cardiologist. As a result, it is desirable to be able to adjust the LV pacing vector as much as possible. The Evia HF-T offers 6 pacing vectors, the most of any device.


• Thoracic impedance is measured a number of times a day to help the cardiologist predict an imminent heart failure decompression which is characterized by an accumulation of fluid in the lungs. In order to be able to predict an acute episode, Home Monitoring is needed.

If you are in the early stage of heart failure with a QRS width > 150 ms, you may want to consider implanting an Evia HF-T system. Recent clinical studies have shown that early intervention can halt and reverse the progression of heart failure. If you are still young, <85 years, an MR conditional system will allow you to be MRIed, should it ever become necessary. So, don't take a chance, get a completely MR conditional CRT system!

For the left atrial lead, we offer a range of Corox ProMRI bipolar lead. The Corrox ProMRI OTW with its unique 3D spiral shape to adhere securely to medium to small coronary veins. A new addition, appropriate for patients with small veins, is the -S version shown below, with a silicone screw thread at the far end. The -L patient is suited for medium coronary vein. All the Corox ProMRI leads have two electrodes. For very small to medium veins, there is also the Sentus unipolar (not MR conditional) lead (below).

Simply the best pacemaker and defibrillator in Vienam - 2014

For our visitors from Cambodia and Laos

A clinic in Phnom-Penh is implanting single chamber devices. We have a large number of customers who have come to Vietnam from Laos and Cambodia for device implant. If you have a cardiac rhythm problem and believe you need to implant a device and would like to come to Vietnam, we can make arrangements for you to be examined by a Vietnamese cardiologist and to receive an implant, if needed. The Biotronik devices have a worldwide warranty. The cost of Vietnamese care is less than what it would cost you in Singapore or Thailand. Please feel free to contact us at nwspi@comcast.net

For our visitors from the US

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The US is one of the few major countries without universal health insurance. If you are a US resident, in particular a Vietnamese-American, not covered by medical insurance and have been diagnosed to need a pacemaker/defibrillator implant, the alternative to an expensive US procedure is to come back for a vacation to Vietnam and have a Vietnamese cardiologist examine you and if needed, implant a device. The cost of the trip, the exams and implant of a top of the line pacemaker, for example the Evia DR, is significantly less than what a basic device alone would cost you in the US. Andit is also MR conditional, which means that you can have an MRI scan (In the US, this should be feasible as of May 2014) If you need a defibrillator, an Iforia 7 with Home Monitoring is the best system you can get anywhere in the world. High marketing cost in the US is the cause for the high implant cost in the US, on top of medical malpractice insurances. The Biotronik devices have a worldwide warranty and can be followed at US clinics, if needed. If you have a need for such a device, please feel free to contact us at nwspi@comcast.net and we can provide you with the introduction to a Vietnamese hospital close to where your relatives/friends live in Vietnam. If you prefer to stay at one of the excellent private clinics, and the clinic does not have the appropriate cardiologist on their staff, we can make arrangements for you to have an experienced cardiologist from a nearby implanting hospital come and perform the implant, and follow you during your stay. Follow-ups in the US and Europe are not a problem since a number of our patients in Vietnam have emigrated to the US and Europe and they have not experienced any problem having their devices monitored at US and European clinics.

If you already have a US cardiologist, you can still come to Vietnam for the implant of a defibrillator or triple chamber device, and then visit your local cardiologist for any needed follow-up. Your cardiologist should have the equipment provided by Biotronik to perform any needed follow-up. Again, the total cost of the implant of these advanced devices is significantly lower in Vietnam. An estimate, about 5 years ago, for the implant cost of a basic single chamber defibrillator in the US ranges from USD100K to USD150K. For that amount, you can afford to have a top of the line defibrillator implanted in Vietnam, for example the Iforia 7 DR-T or, in the case of heart failure, an Iforia 7 HF-T the latest Biotronik dual/triple chamber ICDs, with Home Monitoring and then fly back to Vietnam every 3-6 month for follow-up, and still have cash left over!  
The most expensive devices are normally not stocked in Vietnam. But we can have them on a week's notice directly from Biotronik. 

Medical Tourism

Found the following article recently. It quotes a pacemaker implant costing $7,500 in Bangkok, versus $83,600 in the US. For $7.500 you can get the MR conditional Evia DR implanted AND have a nice vacation in Vietnam! So, try Saigon, not Bangkok! And if you want absolute peace of mind, implant an Evia DR-T with Home Monitoring! You cannot get such a system in Bangkok because Home Monitoring is not available in Thailand. The Home Monitoring system will continue working once you get back to the US, or for that matter anywhere in the world where your iPhone works.

We can make arrangements for you to stay at a comfortable private clinic and we will invite the best implanter to come to the hospital to implant the device. In a couple of days time, you can be off to some beach to spend the rest of your vacation.

Sick? Find your doctor, then call a travel agent
Published Thursday, August 13, 2009

To the gentleman who listed his ailments of the past four years and anyone interested in health care, mainly the underinsured and uninsured population, please read the article, "Need Surgery? Call a Travel Agent," in the October 2008 issue of Men's Health magazine (www.menshealth.com).Type the name of the article in the search box, and you should be able to click on the five-page article.

Medical tourism patient costs are lower mainly because of hospital labor costs, administrative costs and malpractice costs.

Payments essentially are cash only at a Bangkok hospital, with health insurance being less than 15 percent. The hospital is the busiest in the world, with labor representing 17 percent of hospital revenue. In the U.S., it is almost 50 percent. In 2007, doctors treated 420,000 foreign patients from 190 nations. Among the 900 doctors, 200 are U.S.-board certified.

Ready for the bill? Here are some medical tourism treatments and prices:lumbar disc excision, $7,500, Mexico and $37,500, U.S.; angioplasty, $8,200, Bangkok and $45,200, U.S.; new knee, $6,500 India and $39,800, U.S.; spinal fuse, $13,500, India and$59,100, U.S.; new hip, $6,500, India and $42,400, U.S.; coronary-artery bypass, $8,500, India and $96,400, U.S.; and cardiac pacemaker, $7,500, Bangkok and $83,600, U.S.

Medical tourism generally involves better care, price, recovery and lower infection rate than the U.S.

Mexico anyone?  

From John Connel, Medical Tourism, CABI International, Oxfordshire, UK, 2011.

For 6,000 USD, you can get an Evia DR which is MR conditional, not just a single chamber device as seemed to be implied in the above table for India. For a total bill of <10,000 USD you can get the high end devices and have a nice vacation that has saved you >50,000 USD.

And if you want the latest generation of products, India is not necessarily the place to get them. In 2013 the latest Biotronik generation of ICDs, the Iforia ICDs, was introduced. You would think that India would be one of the first places in Asia to get the first implant of Iforias. You are wrong! Here are some dates

• The first Iforia 3 HF-T was implanted in Vietnam on the 22nd of July 2013,
• The first MR conditional Iforia 5 VR-T with DF-4 connector was implanted in Vietnam on the 12th of August 2013
• The first Iforia DF-4 was implanted in India the week of September 16, 2013, close to 2 months after we introduced the Iforia's in Vietnam.
  

Systolic Medical Products

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Systolic Medical Products Import-Export Limited (Công ty trách nhiệm hữu hạn xuất nhập khẩu trang thiết bị y-tế Tâm Thu) is currently the largest supplier of cardiac rhythm management products in Vietnam. Our main implant centers are in Hanoi, Hue, Hochiminh City. We got to our current dominant position by providing

• outstanding service to our customers. For example this extensive website with over a Gigabyte of materials to help Vietnamese customers understand the underlying disease, the treatment and the therapeutic devices available. Literature is available in Vietnamese, and other languages upon request, to patients to explain the function of the device and how the patients should care for the implanted devices. Our competitors have copied our literature, but cannot match the information provided at our website.
• and outstanding support to implanting cardiologist with frequent training seminars and consultation whenever needed. In March 2008, we just finished a series of 3 training workshops in Hanoi, Hue, Hochiminh City to train cardiologists on the programming of our devices. Without the knowledge to program the devices, a top of the line device may be no better than a basic device! Dr. Tran Thong, who led the pacemaker and defibrillator design team of Biotronik, and now is a Professor of Biomedical Engineering researching heart rhythm, is available to Vietnamese cardiologists for consultation should they have any question on the devices implanted. Since he has given many seminars over the past 16 years (since 1995) delivered in Vietnamese, unlike support from other companies that is provided in English, language is no barrier for him when Vietnamese implanting cardiologists encounter a problem with an implant. No other supplier provides such support for Vietnamese cardiologists.  

So, you owe it to yourself and your health to deal with the best!


Our pacemaker implant centers in Vietnam are located at hospitals in the following cities, going from North to South,

• Hanoi
• Haiphong
• Thanh Hoa
• Vinh
• Hue
• Danang
• Quy Nhon
• Buon Ma Thuot
• Nha Trang
• Bien Hoa
• Hochiminh City
• Rach Gia

We have a couple of private and semi-public hospitals in Hochiminh City we will recommend based on their implant skills (we rate them very high) and patient service (average - still some of the best in Vietnam). Please contact us if interested. For emergency, contact us for the nearest hospitals.