Press Releases and Statements

BIOTRONIK announced the presentation of the 12-month results from the BIONETIC-I study this week at LINC 2024. The prospective, international, multicenter single-arm observational study evaluated the treatment of de novo, restenotic or occluded iliac lesions in 160 patients with Rutherford Class 2-6 peripheral artery disease using the Dynetic ®-35 cobalt chromium balloon-expandable stent system. At baseline, 12.5% of enrolled patients had critical limb ischemia, 90% had calcified lesions (30.7% severe calcification), and there was an average of 85.5% stenosis in the target lesion. The primary

On October 11, the US Food and Drug Administration (FDA) issued a Safety Communication regarding cybersecurity updates affecting Medtronic implantable cardiac device programmers, based on an NCCIC Advisory. 1 According to the FDA’s communication, Medtronic is issuing a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the internet connection in two models of programmers used to download software from the manufacturer’s software distribution network (SDN). Successful exploitation of these vulnerabilities would allow an adversary to influence this

CardioMessenger devices form an essential part of BIOTRONIK’s remote monitoring system, enabling the secure transmission of critical patient and device data to the treating physician. As the company that pioneered remote monitoring, we have taken cybersecurity design seriously since 2001. It is integrated into our quality management system, all relevant business processes and prioritized at every step of the product life cycle. Our cardiac implants do not accept programming modifications or commands via any form of long-distance communication. By design, it is technically impossible to

The Department of Homeland Security and the US FDA have issued a Medical Advisory and Safety Communication respectively describing two types of cybersecurity vulnerabilities affecting multiple Medtronic devices that utilize the Conexus telemetry protocol. BIOTRONIK utilizes substantially different protocols for both the clinical and the home environment. Moreover, by design, the remote communication system via BIOTRONIK Home Monitoring® does not have the functionality to transmit or alter therapeutic commands to the implant.

The work ‘Security Testing of the Pacemaker Ecosystem’ was recently published as a master’s thesis, authored by Mr. Anders Been Wilhelmsen and Mr. Eivind Skjelmo Kristiansen. This publication investigates the state of cybersecurity of BIOTRONIK’s ICS 3000 – a programmer for BIOTRONIK implantable cardiac pacemakers, defibrillators and monitors that is used by healthcare professionals during the implantation procedure and follow-ups. ICS 3000 programmers were distributed between 2001 and 2012. In the publication, the authors report about several cybersecurity weaknesses such as: The central

On August 9, WIRED magazine reported that researchers discovered cybersecurity vulnerabilities in the way pacemaker programmers connected to the software delivery network of a specified manufacturer. The researchers claim that “digital code signing”—the cryptographic validation of the legitimacy and integrity of software—is lacking in the manufacturer’s infrastructure, allowing an attacker to potentially take control of device programmers through malicious updates that can subsequently be spread to implanted pacemakers. 1 None of BIOTRONIK’s devices, programmers or networks are affected by

On October 1, the US Food and Drug Administration (FDA) issued a Safety Communication regarding a set of cybersecurity vulnerabilities, referred to as “Urgent/11” that — if exploited by a remote attacker — may introduce risks for medical devices and hospital networks. According to the communication: “These vulnerabilities may allow anyone to remotely take control of the medical device and change its function, cause denial of service, or cause information leaks or logical flaws, which may prevent device function.” These vulnerabilities exist in a third-party software component known as IPnet

Dr. Fadi Mansour performed the first Canadian implant of BIOTRONIK’s newest pacemaker and CRT-P generation earlier this year at the Centre Hospitalier de l'Université de Montréal. The patient received an Amvia Sky HF-T QP triple chamber pacemaker device. The first implant follows the full market release of BIOTRONIK’s newest family of pacemaker and CRT-P devices, featuring patient-centric technologies for better patient care and simplified workflows. “The Amvia Sky HF-T QP offers a significant number of advanced features, making it the most complete CRT-P on the market including streamlined

BIOTRONIK is pleased to announce the availability of an expanded Maximum Allowed Diameters (MAD) range for the Orsiro® Mission Drug Eluting Stent (DES). Diameters 2.25mm to 3.00mm of the Orsiro Mission DES can now be extended up to 4.0mm, while diameters 3.5mm and 4.0mm can reach up to 5.0mm. This new MAD expansion follows the approvals from CE, FDA, and Health Canada obtained in the past months. This update reflects a global effort for the Orsiro Mission stent technology to match contemporary Percutaneous Coronary Intervention (PCI), enabling practitioners to optimize vessel apposition and

Results from the BENEFIT-02 trial – the first of its kind to clinically evaluate a multiphase stimulation paradigm – support the effectiveness of RESONANCE multiphase stimulation used in the BIOTRONIK Neuro Prospera™ spinal cord stimulation (SCS) System in the treatment of patients with chronic pain. In contrast to other currently available SCS therapies, RESONANCE requires less power and uses a proprietary integrated circuit design to deliver a continuous, spatially and temporally distributed therapeutic pulse pattern across the spinal cord. Results of the study were recently published in

The most recent series of Apple iPhones include a stronger magnetic array than previous models. A recent study 1 published in the HeartRhythm Journal reported that therapy was suspended when an iPhone 12 was brought into close contact with specific implanted cardioverter defibrillator (ICD) devices. After further investigation, BIOTRONIK has concluded that there is no additional risk and our advice concerning potential interference from this and former iPhone models remains unchanged. We continue to advise patients implanted with BIOTRONIK cardiac devices to maintain the recommended distance