It will be available in Europe from next June

The port of a pacemaker among the contraindications to an MRI. Or rather was included. Because, Medtronic, the world leader in medical devices, has developed the first MRI-compatible pacemaker. It will be available in Europe from next June. It is an important step forward, because it is estimated that 75 of the pacemaker carriers - they are 2 million in Europe - will one day need an MRI. Indeed, after sixty-five years, the probability of needing an MRI double. However, it is also an age where more and more people suffer from cardiac arrhythmia, and are thus implanting a pacemaker.

MRI uses powerful magnetic fields and radio waves that can damage electrical circuits or probes of the pacemaker with either inhibition or arrhythmia risk. Medtronic has developed ten years to develop a suitable model. "To achieve this, says Bernard Candelon, Director of the division CDRM of Medtronic France, our engineers are involved at three levels: the enclosure, software, and probes. The design of the casing has been reviewed with a decrease of ferromagnetic components and the protection of internal systems. -Side software, you can program the pacemaker through the skin before the examination, so that data recording and monitoring of the appliance functions are suspended, while stimulation is continued if necessary. This mode of programming called "Sure Scan", which also gives its name to this generation of pacemakers, thus isolating system of the external environment during the review. Last element probes see their modified geometric configuration and the size of the insulation increased to avoid radio frequency waves will cause their warm-up.

Clinical study

"If the development of this new pacemaker was also long, it is that the risk reduction was achieved gradually," explains Bernard Candelon. Each change was first tested on a "ghost" (copy of core foam a gel), on the animal, by mathematical modeling, and human finally.

The latest version, which will be placed on the market of mid-2010, has been validated through a multi-center clinical study included 464 patients. For this, a first group of patients implanted with the pacemaker was subjected to an MRI and the State of their equipment after eleven months was compared to that of a second group who had not undergone review. But no difference was detected between the devices of the two groups, which led to the decision to launch.

Competitive advantage

"To be quite specific, however note Frédéric Anselme, cardiologist at the Rouen CHU, who participated in the clinical study, the cardiac area itself has been excluded from the study by maximum precaution." But this gap will soon be filled by a new clinical study which will begin next spring and in which the pacemaker will be this time located at the level of the magnetic field of the MRI.

The pacemaker is destined to become the new standard This is of course the goal of Medtronic, which provides a launch at European level in the first place, then American with a few months of delay. In France, the price should not differ much from the current rate of support for Medicare (4.264 euros) in order to accelerate the substitution with the existing promoters and allow Medtronic take advantage of this competitive advantage to gain market share. But it will take despite all some time, due to the habits of requirements of physicians. The first patients to benefit will be those who have a high probability that they need an MRI.