Press Releases and Statements

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.

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

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

As the COVID-19 pandemic continues, we are conscious of the enormous strain that you are all under. We share your concerns about the spread of the virus and the disruption it is causing globally. We are doing what we can to help minimize this disruption and to provide support so that you can focus on the critical task of saving lives. To this end, we would like to inform you of the following:

The discovery of a high-severity vulnerability known as Log4Shell was disclosed publicly on December 9, 2021, while a related lower-severity vulnerability was disclosed on December 14, 2021. These vulnerabilities are present in a software library used by many servers worldwide (see Background for details). In light of this recent discovery, BIOTRONIK has carefully analyzed all of its provided services. The analysis concluded that the conditions for exploitation of the Log4Shell vulnerability and the related CVE-2021-45046 and CVE-2021-45105 vulnerabilities do not exist in any of BIOTRONIK’s

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

In the first-in-human study BIOMAG-I, BIOTRONIK’s new-generation DREAMS 3G resorbable magnesium scaffold (RMS) showed significantly lower in-scaffold late lumen loss (LLL) than its predecessor at 12 months as well as excellent safety and efficacy. Prof. Michael Haude, BIOMAG-I Coordinating Clinical Investigator, presented the latest results in the late breaking trial session at the EuroPCR course. 1 At one-year follow-up, BIOMAG-I data confirmed the excellent safety profile of DREAMS 3G RMS with a low target lesion failure rate of 2.6%. Neither cardiac death and myocardial infarction occurred

During a Late-Breaking Session at the annual meeting of the European Heart Rhythm Association (EHRA), Dr. Ennio C. L. Pisanò, Vito Fazzi Hospital, Lecce, Italy, unveiled groundbreaking clinical findings from the randomized, multicenter B3 study 1 regarding the impact of CLS on the incidence of Subclinical AF in SND patients. CLS is a unique rate-adaptive algorithm that is able to detect not only movement but emotional stress, physical stress, or physical activity. In essence, CLS is an impedance-based sensor that translates changes in cardiac contractility to increase heart rate –mimicking a

A recent study highlights that implantable cardioverter-defibrillator (ICD) patients with new-onset atrial high-rate episodes (AHRE) often show high stroke risk while not being on oral anticoagulation (OAC), underlining the relevance of continuous AHRE burden monitoring. 1 The study also reports that the combination of BIOTRONIK’s unique DX ICD system with Home Monitoring is an effective and convenient way to detect AHRE. 1 REACT DX is a prospective, multi-center registry that enrolled 234 de novo ICD patients from 14 centers in Germany. It assessed the incidence of new-onset AHRE in an ICD

In a late breaking trial session during EuroPCR 2023 in Paris, on behalf of the HOST-IDEA study investigators, Dr. Hyo-Soo Kim presented the results of a stent level analysis comparing two ultrathin strut drug-eluting stents (DES): Orsiro ® and Coroflex ISAR. The post-hoc comparison revealed significant differences in efficacy. HOST-IDEA is a large scale, multicenter, all-comers randomized controlled trial that demonstrated the non-inferiority of 3- to 6-month versus 12-month dual antiplatelet therapy (DAPT) after implantation of ultrathin strut DES. 2,173 patients in 37 South Korean centers

BIOTRONIK announced the one-year subgroup results from the investigator-initiated BIOPACT randomized controlled trial (RCT), which were presented by principal investigator Dr. Koen Deloose at LINC, the Leipzig Interventional Course 2023. The randomized controlled non-inferiority trial evaluated the safety and efficacy of the Passeo ®-18 Lux ® drug-coated balloon (DCB) catheter compared to the In.Pact Admiral DCB (Medtronic) and showed excellent results for both balloons through 12 months across a variety of sub-cohorts. The prospective, multicenter, core-lab adjudicated non-inferiority study

The TIMELY consortium announced today the enrollment of the first patient in the randomized controlled clinical TIMELY trial. The TIMELY study investigates to what extent the AI-supported TIMELY platform improves the health of myocardial infarction (MI) patients and other patients with coronary heart disease after cardiac rehabilitation. Around 1.8 million people in the European Union die each year from coronary heart disease. 1 To prevent reinfarctions, patients receive cardiac rehabilitation to support necessary changes in lifestyle habits, such as diet and increased physical activity