The First Workshop on Active Implantable Medical Devices took place at in Punta del Este, Uruguay last Friday (March 1st 2024) as part of the LASCAS 2024 meeting.
Category Archives: Biotronik
Biotronik Receives FDA Approval for Prospera SCS System (March 2023)
Biotronik received FDA approval for its Prospera™ Spinal Cord Stimulation System on March 31, 2023. The system is intended to treat chronic, intractable pain in the trunk or limbs.
The Prospera SCS System includes a rechargeable IPG, SCS leads, a clinician programmer, a patient programmer, and an external trial pulse generator.
The system features connectivity with Biotronik’s Embrace One™, which the company claims to provide automatic, objective, remote daily data transmission for true proactive care management.
FDA Clears Vital Data Sensor in Biotronik’s Biomonitor IIIm ICM
FDA has cleared Biotronik’s Vital Data Sensor to identify body temperature increases potentially associated with fever as part of its new Biomonitor IIIm injectable cardiac monitor (ICM).
The device has shown to achieve a 72 percent reduction in false positives while maintaining 100 percent of AF-related sensitivity. It removes single ectopic beats out of the AF detection algorithm, enhancing diagnostic accuracy.
According to Biotronik, “BIOMONITOR IIIm is the industry leader in battery longevity with 5.5 years of continuous service, providing long-term post-ablation or cryptogenic stroke monitoring. It is also backed by the Patient App, which allows patients to include vital symptom data, providing physicians with symptom-rhythm correlation which strengthens diagnostic precision.”
Biotronik Launches Single-Pass Dual-Chamber Defibrillation System
Biotronik announced yesterday the full commercial launch of the Acticor device family, including Acticor DX and CRT-DX devices. The unique feature of the system is the single-pass lead with its floating atrial sensing rings. According to the press release:
“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.”
FDA Approves Biotronik’s Acticor and Rivacor CRM Device Families. Biotronik Changes IPG Shape?
FDA has approved Biotronik’s Acticor and Rivacor high-voltage CRM Device Families. According to the press release the six new tachycardia solutions include Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX.
The Acticor and Rivacor IPGs have a smooth, elliptical “BIOshape” and are the smallest and slimmest 3 Tesla (3T) MR-conditional CRM devices currently on the market. The devices also feature extended longevity—nearly 15 years for VR-T, 13.5 years for DR-T, 14 years for DX and nine years for CRT.
The Acticor family offers Biotronik’s “DX technology”, which provides atrial diagnostics without an atrial lead. DX systems can detect silent atrial fibrillation for stroke prevention, enhance diagnostic accuracy for better clinical decision-making and allow for dual-chamber supraventricular tachycardia (SVT) discrimination to prevent unnecessary shocks.
The Rivacor HF-T QP offer 20 LV pacing vectors and cardiac resynchronization therapy (CRT) optimization with intelligent CRT AutoAdapt programming to automatically adjust to changes in patient conditions.
Acticor and Rivacor also feature MRI AutoDetect technology, which automatically recognizes when a patient enters an MRI environment and adjusts therapy for the duration of the scan.
Biotronik’s website: https://www.biotronik.com
Biotronik Receives FDA Approval for Ilesto 7 ICD/CRT-D Series
Biotronik announced that FDA granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. According to the press release:
“BIOTRONIK lives up to its reputation for excellence in design and manufacturing with the introduction of the Ilesto family, and the new Ilesto DX device. Physicians depend on complete and timely information, and Ilesto DX with BIOTRONIK Home Monitoring® certainly delivers. With this device, physicians can receive atrial information to ensure diagnostic accuracy and identify previously undetected atrial fibrillation. They also receive peace of mind that there is less risk of complications due to the single lead,” said Paul Woodstock, executive vice president of sales and marketing at BIOTRONIK, Inc., USA. “Ilesto’s smaller footprint will be more comfortable as well, which may present a win-win solution for patients and physicians alike.”
Biotronik’s Iforia DF4 ICD/CRT-D CE-Approved as Compatible with MRI
Biotronik announced that it had received CE-approval for the world’s first DF4 ICD/CRT-D series approved for MRI. In addition, this series contains one of the world’s smallest ICDs– the Iforia single chamber ICD.
Aside from featuring ProMRI®technology, which allows patients to undergo potentially life saving MRI scans, Iforia also includes the industry standard DF4 connector system, which is designed to simplify and shorten the implantation procedure. The DF4 connector combines the traditional three connectors into one, allowing for a more convenient implantation procedure without compromising safety.
Click here for the press release.
Biotronik Launches Implantable BioMonitor for Monitoring Arrhythmias
Biotronik announced the European market release of BioMonitor®, an implantable cardiac device designed for the highly accurate and reliable monitoring and management of patients with atrial fibrillation (AF) or unexplained syncope.
According to Biotronik’s press release:
“BioMonitor® is a subcutaneous implantable leadless cardiac monitor for the long-term continuous remote monitoring of patients with arrhythmias such as AF, bradycardia, sudden rate drop, asystole and tachycardia.
As sensitivity and specificity are essential in the detection of arrhythmias such as AF, BIOTRONIK has developed ClearSense Technology with a unique three-vector signal detection that produces highly precise and reliable arrhythmia monitoring.
Micro Systems Technologies Offers Active Implantable Medical Device Development/Manufacturing Services
Micro Systems Technologies (MST) is the vertically-integrated supplier of microelectronics and implantable-grade components to Biotronik. It now offers its development and manufacturing services to others.
Through its companies, MST offers high-reliability microelectronic modules for implantable medical devices such as pacemakers, defibrillators, neurostimulators, and cochlear implants.
MST can provide integrated solutions encompassing everything from conceptual design through high-volume surface-mount (SMT) assembly of modules. Services include design development of customer-defined electronic modules, custom ASIC design and development, and high-density-interconnect (HDI) substrate and assembly design.
As a OEM, MST offers state-of-the-art automated SMT line, an ISO 13485–compliant process and component verification and validation methodology, a manufacturing execution system that automates data collection, analysis, and process control, and comprehensive supply-chain management and monitoring with 100% traceability. Continue reading