Press Releases and Statements

BIOTRONIK today announces the launch of the latest innovations in guide extension catheters: FlowGuide and Guidion Short. These new devices have been developed to offer enhanced support and to facilitate the delivery of devices during complex vascular interventions. The catheters introduce key elements, such as perfusion holes in the distal shaft of the FlowGuide catheter, and a transradial access and trapping friendly design for both new products. Through our collaboration with IMDS, the FlowGuide and Guidion Short catheters expand BIOTRONIK's portfolio of high-performance devices dedicated

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

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

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

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

In a recent prospective, international, multicenter, nonrandomized trial, the BIO|MASTER.Selectra 3D study assessed the performance and safety of BIOTRONIK’s Selectra 3D guiding catheter, revealing compelling insights into its ease of handling and effectiveness. Conducted across 10 centers in Australia, Hong Kong and Europe, the study included 157 patients who underwent a CSP procedure for bradycardia pacing or heart failure indications. The results of this research have been published in the Heart Rhythm O 2 journal. 1 Key Findings of the BIO|MASTER.Selectra 3D Study: High Success Rate in

BIOTRONIK announced the milestone achievement of 100,000 implanted single-chamber implantable cardioverter-defibrillators (ICDs) equipped with DX Technology. Since the introduction of this unique technology in 2009, clinicians in more than 80 countries across all continents use DX ICDs. “Reaching this significant milestone, BIOTRONIK stands as a proud pioneer and partner in cardiac rhythm management. Our commitment to quality and focus on innovation sets us apart, allowing us to introduce meaningful innovations in the market, such as DX Technology, that make a real difference in patients’

BIOTRONIK is pleased to announce the release of the results of the BENEFIT-01 study published in Neuromodulation. 1 The prospective, multi-center study was designed to investigate the influence of clinically relevant Spinal Cord Stimulation (SCS) parameters on patient perception. BENEFIT-01 marked the beginning of a series of SCS clinical studies with the aim of developing an SCS technology that provides sustained pain relief with few side effects. From July to November 2017, 40 patients with low back and/or leg pain who had completed a commercial SCS trial were enrolled at seven clinical

BIOTRONIK announced today the opening of its new Asia Pacific Manufacturing and Research Hub. The 20,000 m² site will serve as the company’s central hub in Asia-Pacific, with hundreds of employees working in manufacturing, quality, research & development (R&D), and sales and marketing. BIOTRONIK, founded in Berlin, Germany, in 1963 is a pioneer in implantable pacemakers, defibrillators, and vascular intervention for 60 years. BIOTRONIK’s presence in Singapore began in 2012, and in 2016, the company inaugurated its first manufacturing site, complementing its high-quality manufacturing sites in

BIOTRONIK is proud to introduce the Micro Rx™ catheter, a novel rapid exchange microcatheter developed to easily enhance guidewire support during percutaneous coronary interventions (PCI). This cutting-edge device, exclusively distributed by BIOTRONIK, is manufactured by IMDS (Interventional Medical Device Solutions). Micro Rx catheter marks the fourth IMDS product BIOTRONIK has brought to the U.S., creating a compelling portfolio of devices which includes NHancer Rx, TrapIT, and ReCross catheters. The Micro Rx catheter features a reinforced distal shaft with a core wire between two layers of

BIOTRONIK announces the CE approval and launch of Freesolve™ Resorbable Magnesium Scaffold (RMS). This third generation RMS has been engineered to provide optimized vessel support, yet achieves magnesium resorption within 12 months. 1 The new Freesolve RMS is a groundbreaking vascular advancement based on reliable clinical evidence. Recent BIOMAG-I trial data highlights an exceptional 99.3% magnesium strut degradation 12 months after implantation 2, consistent performance, regardless of lesion characteristics, and restoration of vasomotion. 3 "Having closely observed the evolution of

BIOTRONIK announced the presentation of two-year results from the investigator-initiated BIOPACT RCT by Principal Investigator Dr. Koen Deloose at the Paris Vascular Insights 2023 congress. 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 24 months. 1 The prospective, multicenter, core-lab adjudicated non-inferiority trial enrolled 302 patients in Austria, Belgium, France and Switzerland with