Wednesday, June 18, 2008

Call with Medtronic

Late last month, Kat and I traveled to New Jersey to attend the annual conference of the Hypertrophic Cardiomyopathy Association. While at the conference, we met a Medtronic PR manager and told her about our local San Francisco Bay Area ICD User group.

In light of our chat, she invited us to participate on a call with other Medtronic employees to tell them about our ICD User Group, what we do, as well as to hear our stories.

This was also a great opportunity to ask them some questions. Here are the answers we got.

Q. Patients believe they have the ability to influence their doctors over what brand/device model they’ll receive. While EPs and sales reps eventually retire, patients do not. A patient's experience with ICD therapy is a life-long journey. Thus, we believe patients must be included in the decision-making process as equal-part stakeholders. How often are patients part of the decision over device manufacturer?

A. Patients have more say now than ever before as to which manufacturer's device is implanted. Some patients are very active in this decision-making process and others are not, either because they did not know they had a choice or prefer to not be in the position to have to decide.

Q. I saw in one of your brochures (series Leadership Defined) that Medtronics ICDs use a proprietary battery charging technology that allows for a charge time of 16 seconds (on the Virtuoso DR and Concerto CRT-D). The brochure also says that Boston Scientific and St. Jude ICDs use conventional Silver Vanadium Oxide (SVO) in their batteries resulting in a charge 10 seconds longer for the Boston Scientific Vitality DR and Contak Renewal ICDs (St. Jude charging times are not available). Another brochure claims that “Medtronic had the greatest percent of ICDs in service after 5 years, and the only manufacturer with devices in service after 8 years.” These sound like significant advantages for patients who have to endure occasional life-saving shocks and periodic device replacements. How come we never hear these points from our doctors?

A. Unfortunately, doctors don’t always have statistics like this readily available to discuss with patients and most patients don’t ask. It is easy to get the information and in the case of charge times, something that we definitely talk about with doctors, but each doctor uses the information differently.

It is becoming easier for patients to access this information and that is a good thing. We are going in the right direction, getting information like this out to patients so they can be more involved in the decisions that are made about their treatment. Medtronic has a great tool in our websites www.medtronic.com and www.hearthelp.com for both current patients and those thinking about device therapy. We also have people available to answer questions on the phone.

Q. Your web site says that "no other company offers as broad a line of ICDs and leads" (I counted 14 different ICD models alone). What's the main difference among the ICD models offered by Medtronic and are these differences significant enough for a patient to care about them?

A. Some differences are due to new technology for treating patients and other differences are related more to the diagnostics of the device as we discussed on the phone. Some differences can be significant to some patients based on their heart condition. An example of this would be “MVP (Managed Ventricular Pacing)”.

Studies have shown the unnecessary pacing in the ventricle can be detrimental to a patient in the long term. MVP allows the devices to cut back significantly on unnecessary ventricular pacing. MVP can not be used in every situation so this feature may or may not benefit an individual patient based on their heart condition

Q. How about the leads? Why so many different models? Should patients demand one model over another? What are the advantages of one lead over the next one?

A. Leads have different designs that work better in certain patients just like therapies in the devices work better for different heart conditions. Leads are actually very intricate medical devices in themselves. Some act strictly to pace and sense what the heart is doing. Some do that and also deliver defibrillation therapies. Some are designed to be placed on the outside of the heart and some on the inside like your leads. Some leads have a silicone outer insulation and some are polyurethane. This makes the lead more or less rigid and also more or less slippery.

Some doctors prefer the feel of one versus another during the implant procedure. Some leads are designed to attach directly to the heart tissue while others simply anchor themselves to the fibers attached to the heart wall. Some leads for the left ventricle essentially just sit in the Coronary Sinus and wedged themselves into place. There are many factors that can be considered with lead selection, just like device selection.

Q. The wireless models for Boston Scientific incorporate encrypted data, but Medtronic’s wireless devices do not and one model (Medtronic Maximo DR) was able to be hacked into during outside testing (download PDF of the study here). While it may be a long shot that anyone would do this, what is being done to address this issue?

A. The data on your Carelink transmissions (if you use a home monitor) is encrypted from the monitor to the network over the phone lines. It is not encrypted from the device to the monitor or from the device to the programmer. Medtronic is aware of the study that was done. This scenario is not likely to occur outside of a laboratory setting.

The person “taking over” the implanted device would have to know a person has a device and have intent to hack in. They would also have to be within a certain distance of the implanted device. Without giving an exact distance, unless a patient is sleeping, they will know the person is there and most certainly wonder what they are doing. With that said, I know this has generated discussions within Medtronic regarding changes to future devices. This is not something we had to think about years ago, but we do need to change as technology changes and patient safety is our number one responsibility and priority.

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