MINIATURE CARDIOSTIMULATOR: 10 years of work, more than 250 patients in the Czech Republic

The story of the miniature intravenous pacemaker began in 2010, when the first project plan was drawn up. It first mentioned an implantable capsule that would be able to do what much larger single-chamber pacemakers can do, without probes inserted into the heart muscle. The plan also mentions that it will communicate exclusively with a functional programmer.

The basis of the project was a modified virtual patient. This miniature pacemaker is based on a platform used for cardioverter/defibrillator devices. Once the modifications to the existing software application were completed, the modified application was verified, allowing for the first meeting to take place to see if the software application could be formally tested.

CertiCon has played a significant role on this key project throughout its 10-year lifecycle. We ensured its localization for European and Asian countries. We helped to get the pacemaker data into the system via home monitors or mobile apps. During the transition to a new programmer, it was CertiCon who owned and managed the entire project. Our team brought this pacemaker to a successful conclusion and it is now supported on newer types of programmers.

There are more than 250 patients with this pacemaker in the Czech Republic

Like every SW product, it has its flaws. But it also undergoes innovations, and quite dynamically. Thanks to research projects, it has been provided with the necessary data and can use an improved algorithm to accelerometrically sense the ventricle and use the data for improved atrial pacing. A battery is also being developed and with it, a longer lasting device is being offered to patients.

In the Czech Republic, 22 of these devices will be implanted in 2022, and over 21 devices in 2023, for a total of more than 250 patients implanted with a miniature intravenous pacemaker. Interestingly, it is not developed for explantation, i.e. it is not envisaged to replace it in case its battery runs out. Some patients may therefore have several devices placed in the heart at the same time. However, studies are currently underway where, for example, Prof. Neužil from the Hospital Na Homolce proves that by using an implantation kit, it is possible to explant them in addition to implantation.

Doctors have an overview of the patient’s current state of health

However, the development of software applications for programmers is far from the end of our joint story at CertiCon. In order to be able to capture, store and analyze data outside of operating rooms, it was necessary to develop support for these devices. Given the fact that CertiCon is the dominant player when it comes to the development and verification of this system, we were instrumental in adding complete pacemaker support.

In addition, our teams also ensured that the diagnostic data from each transmission was sent and displayed. This key functionality allows physicians to have an overview of the patient’s current health status. Of course, reports containing this data were generated as well as exported to external systems.

Like every pacemaker from our customer, these pacemakers support express transmissions. This is the transmission of heart rate data from the express monitors that are located in ambulances or in hospital reception departments. Our challenge was to provide support here as well, so that paramedics could successfully diagnose the patient with the implanted device and provide immediate assistance.

More than 200,000 patients have been treated since the devices were first implanted in 2013

As implantation of these devices is also a matter of the present, and the current programmers are now an outdated platform, it is necessary to ensure that implantation can also be performed using the new platform. Thus, our role on the program continued to develop support on this platform. Thus, in early spring 2019, we started to work in a smaller team to develop the application. The project to enable the implantation of these devices has grown to several teams with a total of almost 50 engineers.

Our decade with this pacemaker is a remarkable story. This is primarily because CertiCon has played an indispensable role in nearly every aspect of the design, development, verification, and subsequent formal support in the validation of this device. As a result, the project has historically gone through every program group, our engineers have contributed to the fact that since the first implantation of these devices in 2013, more than 200,000 patients have been treated, more than 30,000 subjects have participated in clinical trials on the sub-development arm, and more than 10,000 medical staff worldwide have been trained for implantation.

We would like to thank everyone who contributed in any way to make this miniature intravenous pacemaker possible. The figures above are just proof that our colleagues are capable of dealing with such complex programmes. Their efforts, dedication and skills were, and are, the basis for the success that has accompanied (not only) this product.