A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Biotronik

Biotronik study reveals utility of remote monitoring and remote programming in SCS

Posted on by Posted in Biotronik, Pain, Spinal Cord Stimulation
Biotronik Prospera IPG

Image Credit: Biotronik

In 2023 Biotronik received FDA approval for its Prospera™ Spinal Cord Stimulation System to treat chronic, intractable pain. 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.

A new study using the Prospera® SCS system was published in Neuromodulation supporting the adoption of real-time remote monitoring as a new standard for long-term SCS device management.

According to the press release, the study demonstrates that:

“…automatic, daily remote monitoring of spinal cord stimulation (SCS) devices enables the first real-time visibility into post-implant therapy use, including the identification of “virtual explants” — patients with prolonged device inactivity who have not undergone surgical removal. In the study, patients using the Prospera® SCS system — the only SCS device with automatic, objective, daily remote monitoring and remote programing — maintained high rates of therapy use and low explant rates.”

 

 

 

Biotronik presents 24-month interim data from the BENEFIT-03 clinical study at NANS

Posted on by Posted in Biotronik, Pain, Spinal Cord Stimulation
Biotronik Prospera IPG

Image Credit: Biotronik

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.

This weekend at NANS 2025 Biotronik presented  24-month intermediate data from its BENEFIT-03 prospective, multicenter clinical study in Australia.  Continue reading→

SOMACIS Group acquires Dyconex from Biotronik’s MST

Posted on by Posted in Biotronik, DYCONEX

Dyconex logo

On September 13, 2024 it was announced that Dyconex officially joined the SOMACIS Group headquartered in Italy.

Dyconex is a Swiss company specializing in high-reliability PCBs for medical implantable devices.  It formerly belonged to Biotronik’s MST group, putting it out of reach from many implantable companies that Biotronik saw as potential competitors.  However, their high-rel PCB manufacturing is open to anyone in the Industry.  Details about the acquisition haven’t been made public.

 

Update on Device Based Therapies in Heart Failure published by HFSA

Posted on by Posted in Abbott, Baroreceptor Stimulation, Berlin Heals, Biotronik, Boston Scientific, Cardiac Contractility Modulation, Cardiac Neuromodulation, Cardiac Pacing, Cardiac Stimulation (other), CardioMEMS, Cardioversion/Defibrillation, Circulatory Support, CVRx, Edwards, Endotronix, Heart Failure (CHF), Impulse Dynamics, Medtronic, Microcurrent, Respicardia, Ventricular Assist Device, Viscardia
From: HFSA Scientific Statement: Update on Device Based Therapies in Heart Failure, ESTEP, JERRY D. et al., Journal of Cardiac Failure, 2024

From: HFSA Scientific Statement: Update on Device Based Therapies in Heart Failure, ESTEP, JERRY D. et al., Journal of Cardiac Failure, 2024

The Heart Failure Society of America (HFSA) published today a new Scientific Statement titled “Update on Device Based Therapies in Heart Failure.”  The statement was published online in the Journal of Cardiac Failure (JCF).

This statement discusses how novel device-based therapies, including CCM, BAT, and remote monitoring may bridge current gaps in HF treatment and outcomes.  The statement also proposes a clinical pathway to implement FDA approved device-based therapies that align with current HF management workflow.

 

 

Biotronik Receives FDA Approval for Prospera SCS System (March 2023)

Posted on by Posted in Biotronik, Pain, Spinal Cord Stimulation
Biotronik Prospera SCS

Image Credit: Biotronik (from FDA’s PMA approval)

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

Posted on by Posted in Atrial Flutter/Fib, Biotronik, Bradycardia, ECG Monitoring

Image Credit: Biotronik

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

Posted on by Posted in Biotronik, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Tachycardia

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?

Posted on by Posted in Biotronik, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Tachycardia

Image Credit: Biotronik

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

Posted on by Posted in Biotronik, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Tachycardia

Biotronik Ilesto ICD CRTD David Prutchi PhD www.implantable-device.comBiotronik 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.”

Continue reading→

Biotronik’s Iforia DF4 ICD/CRT-D CE-Approved as Compatible with MRI

Posted on by Posted in Biotronik, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), MRI-safe, Tachycardia

Iforia MRI-compatible ICD/CRT CRT-D David Prutchi PhD www.implantable-device.comBiotronik 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

Posted on by Posted in Atrial Flutter/Fib, Biotronik, Dementia, ECG Monitoring, Tachycardia, Telemetry

Biotronik BioMonitor to diagnose arrhythmias. David Prutchi PhD www.implantable-device.comBiotronik 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.

Continue reading→

Micro Systems Technologies Offers Active Implantable Medical Device Development/Manufacturing Services

Posted on by Posted in Biotronik, DYCONEX, LITRONIK Batterietechnologie, Micro Systems Engineering, Micro Systems Technologies
Micro Systems Technologies offers OEM services to AIMDs

Image Credit: Micro Systems Technologies

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→