BIOTRONIK Announces First Patient Enrollment into BIO│MASTER.Cor Family Study
The Multicenter Study Evaluates the Impact of BIOTRONIK’s Newest Generation of ICDs, CRT-Ds and Leads on Clinic Workflows and Patient Safety
BIOTRONIK announced today that the first patient for the BIO|MASTER.Cor Family study was enrolled at Pauls Stradins Clinical University Hospital in Riga, Latvia at the cardiology department led by Prof. Andrejs Erglis. The patient received a Rivacor 5 HF-T QP device. BIOTRONIK’s BIO│MASTER.Cor Family study follows the recent launch of the company’s Acticor & Rivacor family, featuring the smallest 3 Tesla full-body MR conditional ICD and CRT-D devices worldwide.1
“My first implementation of a Rivacor CRT-D as part of the BIO│MASTER.Cor Family Study was very successful,” said Prof. Andrejs Erglis. “The thinner device with its elliptical BIOshape helped improve handling and implementation.”
The multicenter, international, prospective BIO│MASTER.Cor Family Study is the first trial designed to provide supporting evidence for the clinical safety and workflow benefits of BIOTRONIK’s new ICD and CRT-D systems, particularly assessing the benefits of a thinner and more rounded device shape. The sample size includes 127 patients with standard indications for ICD and CRT-D therapy in 12 clinics across six countries. The study investigates Acticor 7, Rivacor 7 and 5 devices, as well as the Plexa ProMRI S DX lead.
“The goal of the BIO│MASTER.Cor Family Study is to provide supporting evidence for the performance of the new Acticor and Rivacor ICD and CRT-D devices and the Plexa ProMRI S DX lead—particularly what this new technology can do to streamline work in clinics like ours,” commented coordinating investigator Dr. Jan Steffel, Vice Chairman of the Department of Cardiology, University Hospital Zurich, Switzerland. “With the results of this prospective study, we hope to improve clinical therapy and research.”
The study’s endpoints include the Serious Adverse Device Effect-free rate of the Cor Family ICDs, the automatic LV VectorOpt test for the automatic measurement of LV pacing thresholds, and the CRT AutoAdapt feature that continuously adjusts the AV-delay and ventricular pacing configuration based on automatic measurement of electrical intra-cardiac conduction times. Follow-ups are planned at pre-hospital discharge and three months, six months and twelve months after implantation. They include follow-ups on standard pacing and sensing assessments, as well as testing of the new features.
“With our new innovative ICD/CRT-D platform Acticor & Rivacor and our dedication to clinical research, we are confident that the BIO│MASTER.Cor Family Study will contribute to improved therapy methods,” stated Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “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.”
Previous results of the Post-Market Observation (PMO) showed a 90 percent improvement of Acticor & Rivacor devices in patient comfort compared to previous models.2 In addition, 97 percent of implanters evaluated implantation workflow and device connection using the improved lead as “much better” or “better”.3
1. As part of an MR conditional system.
2. Post-Market observation Acticor/Rivacor; final-report, March 1, 2019. Data on file.
3. Post-Market observation Plexa ProMRI S DX; final-report, April 11, 2019. Data on file.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.