Press Releases and Statements

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

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

New two-year follow-up data from the BIOMAG-I first-in-human trial confirms a reliable and predictable long-term safety profile for Freesolve™, the third-generation resorbable magnesium scaffold (RMS), establishing it as a true alternative to contemporary drug-eluting stents (DES). The results were presented by Prof. Dr. Michael Haude at the EuroPCR 2024 conference yesterday in Paris. At the 24-month follow-up, the incidence of target lesion failure (TLF) was 3.5% alongside a corresponding 3.5% incidence of target lesion revascularization (TLR) compares favorably with various second-generation

BIOTRONIK is pleased to announce the limited release of its Oscar ® ( One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter and start of promotional activities at LINC, the Leipzig Interventional Course held June 6-9 in Leipzig, Germany. As indicated per Instructions for Use, the Oscar catheter is intended for dilation of stenotic segments in peripheral vessels. The device is comprised of three fully user-adjustable components (support catheter with integrated Lock Grip, extendable dilator and length-adjustable PTA balloon). It was developed to provide support during access

BIOTRONIK announced today the enrollment of the first patient in the BIOMAG-II trial aiming to evaluate the safety and clinical performance of its new-generation resorbable magnesium scaffold (RMS), Freesolve™, compared to a contemporary drug-eluting stent (DES). "We are delighted to enroll the first patient in the BIOMAG-II trial, which may play a critical role in helping establish resorbable metallic scaffolds as part of clinical practice in the future and I am particularly encouraged by the implantation results of the Freesolve resorbable magnesium scaffold," said Dr. Juan F. Iglesias, HUG

For the first time, a panel of spinal cord stimulation (SCS) experts has developed best practices in the nascent field of remote SCS device management. The recommendations were recently published in Neuromodulation. 1  When cardiac remote monitoring emerged in the early 2000s, an expert consensus responded by establishing a framework of principles to optimize the management of cardiovascular implantable electronic devices (CIEDs) in 2008. Similar wireless technology is available for the treatment of chronic pain patients, and the publication provides critical guidance on best practices to

Prof. Michael Haude, BIOMAG-I Coordinating Clinical Investigator, presented the latest results of the BIOMAG-I clinical study at the Cardiovascular Research Technologies (CRT) meeting. 1 At six months the angiographic and clinical data showed a low in-scaffold late lumen loss (LLL) rate and a good safety profile with no scaffold thrombosis. A low proportion of mal-apposed struts after implantation was observed, at six months struts were no longer discernable. The intravascular imaging documented a preservation of the scaffold area with a low mean neointimal area. Bioresorbable scaffolds have

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

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

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

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