Medtronic, a medical technology, services and solutions company, reported Thursday that its clinical trial for the Medtronic Evera MRI SureScan implantable cardioverter defibrillator (ICD) following magnetic resonance imaging (MRI) scans met its safety and efficacy endpoints.
The Evera MRI Clinical Trial, a multi-center, prospective, controlled clinical trial, is the first randomized study of an MRI-conditional ICD system that allows for full-body 1.5 Tesla (the field strength of the magnet) MRI scans.
Patients with ICDs are contraindicated from receiving MRI scans because of potential interactions between the MRI and device function, and the resulting risks to patients who rely on the life-saving therapies of their ICD. As such, there is a critical unmet need for patients suffering from irregular heart rhythms who require ICDs and who also have conditions that warrant MRI scans, which is the gold standard in soft-tissue imaging.
The company said the study showed that full-body MRI scans do not affect the Evera MRI ICD’s ability to detect potentially lethal heart rhythms and deliver life-saving therapy. The results showed that patients who underwent an MRI did not experienced a significant increase in the pacing capture threshold (PCT), the amount of energy needed to stimulate the heart. Also, the MRI scan did not have any impact on the Evera MRI device’s sensing, detection or therapy delivery in patients that experienced ventricular tachycardia / ventricular fibrillation (an abnormally fast or quivering heart rhythm) post-MRI.
