Pressemitteilungen und Statements

BIOTRONIK gab die Präsentation der 12-Monats-Ergebnisse der BIONETIC-I-Studie diese Woche auf dem LINC 2024 bekannt. In der prospektiven, internationalen, multizentrischen einarmigen Beobachtungsstudie wurde die Behandlung von De-Novo-Läsionen, Restenosen und Okklusionen der Iliakalarterien mit dem Dynetic ®-35 ballonexpandierbaren Kobalt-Chrom-Stentsystem bei 160 Patienten mit peripherer arterieller Verschlusskrankheit der Rutherford-Klassen 2–6 untersucht. Zu Studienbeginn hatten 12,5 % der Proband*innen eine kritische Extremitätenischämie, 90 % wiesen eine Kalzifizierung, 30,7 % eine

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

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 US Food and Drug Administration has issued a Safety Communication regarding a family of cybersecurity vulnerabilities known as SweynTooth, which may introduce risks for certain medical devices that use Bluetooth Low Energy (BLE) wireless communication technology. If exploited, these vulnerabilities can allow unauthorized users to potentially cause a device to stop working, stop it from working correctly and/or bypass security to access certain device functions. The FDA has said it is not aware of any confirmed adverse events related to these vulnerabilities although software to exploit

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

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 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

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

BIOTRONIK gab heute den Einschluss des ersten Patienten in die BIOMAG-II-Studie bekannt. Diese Studie untersucht die Sicherheit und klinische Leistung von Freesolve TM, dem resorbierbaren Magnesium-Scaffold (RMS) der neuen Generation, im Vergleich zu einem aktuellen medikamentfreisetzenden Stent (DES). „Wir freuen uns, den ersten Patienten in die BIOMAG-II-Studie aufnehmen zu können. Die Studie könnte eine entscheidende Rolle bei der Etablierung resorbierbarer Metall-Scaffolds in der klinischen Praxis spielen. Besonders ermutigend finde ich die Implantationsergebnisse des resorbierbaren

Neue Zwei-Jahres-Nachbeobachtungsdaten aus der First-in-Human-Studie BIOMAG-I bestätigen ein zuverlässiges und planbares Langzeit-Sicherheitsprofil für Freesolve TM, den resorbierbaren Magnesium-Scaffold (RMS) der dritten Generation. Sie etablieren Freesolve als echte Alternative zu aktuellen medikamentfreisetzenden Stents (DES). Die Ergebnisse wurden gestern von Prof. Dr. Michael Haude auf der Konferenz EuroPCR 2024 in Paris vorgestellt. Bei der Nachbeobachtung nach 24 Monaten betrug die Inzidenz von Zielläsionsversagen (TLF) und Revaskularisierung der Zielläsion (TLR) jeweils 3,5 %, was im

BIOTRONIK, ein weltweit führendes Medizintechnikunternehmen, das sich auf innovative kardiovaskuläre und endovaskuläre Lösungen spezialisiert hat, gibt eine multinationale Vertriebspartnerschaft mit Texray bekannt, dem Pionier in der Entwicklung eines bahnbrechenden Strahlenschutztextils. Im Rahmen dieser Zusammenarbeit wird BIOTRONIK den Kopfschutz und den erweiterten Schilddrüsenschutz von Texray ab sofort in ausgewählten Ländern Europas und des Nahen Ostens vertreiben. Beide Partner wollen das Bewusstsein für die Bedeutung des Strahlenschutzes für medizinisches Fachpersonal im Katheterlabor