LAKE OSWEGO, Ore., April 29, 2019 /PRNewswire/ -- BIOTRONIK today announced the full commercial launch of the Acticor device family, including Acticor DX and CRT-DX devices. Leading electrophysiologists throughout the United States are now treating patients with the new implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
When implanted with BIOTRONIK's Plexa ProMRI S DX lead, the hybrid ICD Acticor systems offer dual-chamber diagnostics without the need for an atrial lead. Importantly, all three Acticor DX devices feature a new DF4 header configuration with a penta-polar electrode lead cable design that simplifies the implant procedure for physicians.
Drs. Larry Chinitz, New York, NY; Lior Jankelson, New York, NY; and Chafik Assal, Charleston, WV; are among the first in the country to treat patients with Acticor.
"Smaller device systems with greater diagnostic capabilities and longer battery life improve how we treat patients," said Dr. George Thomas, New York, NY. "The new Acticor DX devices offer a simplified DF4 lead connection for the DX system. In my first cases, the slimmer, smoother device fit more easily in the pocket and substantially improved patient comfort post-op. These features bring clinical value and enhance patient quality of life."
BIOTRONIK's unique DX technology enables the detection of silent atrial fibrillation to help prevent stroke, enhances diagnostic accuracy to improve clinical decision-making and allows for supraventricular tachycardia (SVT) discrimination to prevent unnecessary shocks. By reducing the number of leads, procedure times are faster and costs and complications are decreased.
"Acticor DX device systems offer unmatched insight into the atrium without the risk or costs associated with an unnecessary atrial lead," said Ryan Walters, President of BIOTRONIK, Inc. "Clinical evidence suggests this additional atrial data dramatically improves the accuracy of rhythm classification, directly informing real-time therapy for patients.1 DX technology, combined with Acticor's new continuous automation capability, facilitates a more comprehensive understanding of each patient's disease state. This enables customized treatment with streamlined workflows that translate into cost savings for health systems and improved outcomes for patients."
The FDA approved Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX in March along with the Rivacor device family for the treatment of tachycardia and heart failure. Acticor and Rivacor are the smallest and slimmest cardiac rhythm management (CRM) devices approved for use in full-body, 3 Tesla (3T) MRI scans. The new devices measure just 10 mm thin, with a smooth, rounded BIOshape that eases implantation and increases patient comfort.2 The devices have improved battery longevity—nearly 15 years for Rivacor VR-T,3 13.5 years for Rivacor DR-T,4 14 years for Acticor DX5 and 11 years for both Rivacor CRT6 and Acticor CRT-DX.7 They are backed by extended device warranties, giving physicians and health systems confidence in delivering the best care for their patients.
The ultraslim Acticor and Rivacor device systems feature MRI AutoDetect, Closed Loop Stimulation and BIOTRONIK Home Monitoring. As a result, they provide more efficient MRI access, individualized physiological rate response and remote monitoring that is proven to reduce all-cause mortality in heart failure patients by more than 60 percent.8
1 Kim MH et al. J. Interventional Card Electrophysiol. 2003, 9(1).
2 BIOTRONIK data on file. Device shape analysis. February 2019.
3 Remote Monitoring: Daily Transmissions, 3 Channel IEGM: On, Shelf life: 6 months, Semi-annual shocks, 60bpm, RV: 700Ω, 2V@0.4ms, 15% pacing.
4 Remote monitoring: Daily Transmissions 3 Channel IEGM: On, Shelf life: 6 months, Semi-annual shocks, 60bpm RA: 500Ω / RV:700Ω 2.0V@0.4ms 15% pacing.
5 HM daily transmissions, 3 channel IEGMs ON, 6 months UBD, 60 bpm, 700 Ω, 2.0V@0.4ms, 2 shocks per year, 15% pacing.
6 Remote monitoring: Daily Transmissions 2 Channel IEGM: On Shelf life: 6 months, Semi-annual shocks, 60bpm RA, RV, LV: 700Ω, 2.0V@0.4ms 15% atrial pacing, 100% BiV pacing.
7 HM daily transmissions, 3 channel IEGMs ON, 6 months UBD, 60 bpm, 700 Ω, 2.0V@0.4ms RV/LV, 2 shocks per year, 100% BiV pacing.
8 Hindricks G et al. The Lancet. 2014, 384(9943).
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. BIOTRONIK has US offices in New York City and Lake Oswego, Oregon.