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May 29, 2019

Biotronik begins study of Acticor and Rivacor CRM devices

Patient enrolment has begun on Biotroniks study of its new Acticor and Rivacor range of cardiac rhythm management (CRM) devices.

Patient enrolment has begun on Biotronik’s study of its new Acticor and Rivacor range of cardiac rhythm management (CRM) devices.

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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.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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