Patient enrolment has begun on Biotronik’s study of its new Acticor and Rivacor range of cardiac rhythm management (CRM) devices.
Designed for treating heart arrhythmias, the devices are the smallest 3 Tesla magnetic resonance conditional implantable cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy defibrillators (CRT-D) in the world. They come with rounded edges to reduce skin pressure and help lower the risk of skin erosion.
The international, multicentre BIO│MASTER.Cor Family Study is designed to assess the impact of the CRM devices on clinical safety and workflow in 127 patients at 12 sites across six countries.
It will assess Acticor 7 and Rivacor 7 and 5 devices, as well as the Plexa ProMRI S DX lead. The benefits of a thinner and more rounded shape will be tracked during the study.
The first patient in the study has been recruited at Pauls Stradins Clinical University Hospital in Riga, Latvia, and implanted with a Rivacor 5 HF-T QP device.
Leading the cardiology department there, Prof. Andrejs Erglis said: “My first implementation of a Rivacor CRT-D as part of the BIO│MASTER.Cor Family Study was very successful. The thinner device with its elliptical BIOshape helped improve handling and implementation.”
Follow-ups will be conducted at pre-hospital discharge, and at three months, six months and 12 months following implantation. Standard pacing, sensing assessments and new features will be monitored.
Biotronik corporate marketing senior vice-president Dr Alexander Uhl said: “With our new innovative ICD/CRT-D platform Acticor and Rivacor and our dedication to clinical research, we are confident that the BIO│MASTER.Cor Family Study will contribute to improved therapy methods.
“Biotronik currently runs 31 clinical studies worldwide in the CRM/EP area and is strongly committed to providing physicians with profound clinical data for optimal patient therapy.”
The Acticor and Rivacor devices secured US Food and Drug Administration (FDA) approval in March.