Press Releases and Statements

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 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

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 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

On November 8, 2023, Acutus Medical announced they will immediately begin winding down manufacturing and distribution of the AcQMap 3D Mapping System, the AcQMap/SentiCath 3D Mapping Catheter, the AlCath Force Catheters, the Qubic Force, the AcQGuide/Adnovo Max 2.0 steerable sheath, and associated accessories. According to the company statement this is driven by challenges in the current financing environment. BIOTRONIK, as the distribution partner of Acutus in many countries around the world, deeply regrets this decision. BIOTRONIK had not been informed in advance of this development. We will

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

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

BIOTRONIK announced the two-year-results from the BIOLUX P-III BENELUX all-comers registry, presented by Principal Investigator Prof. Frank Vermassen at CIRSE 2023 in Copenhagen, Denmark. 1 The prospective, international, multicenter post-market registry evaluated the safety and efficacy of the Passeo ®-18 Lux ® drug-coated balloon (DCB) catheter in isolated popliteal artery lesions. This indication is considered a difficult vessel bed to treat due to its biomechanical constraints that usually preclude the placement of stents. BIOLUX P-III BENELUX registry enrolled 99 patients in Belgium, the

New data from the BIOMAG-I first-in-human trial shed light on the vascular healing process following the implantation of DREAMS 3G, BIOTRONIK’s third-generation resorbable magnesium scaffold (RMS). A detailed intravascular optical coherence tomography (OCT) analysis demonstrated that 99.3% of the struts completely degraded at one year. 1 Dr. Masaru Seguchi from the German Heart Centre in Munich, Germany presented the findings at the European Society of Cardiology’s (ESC) congress in Amsterdam. While earlier BIOMAG-I study results provided favorable outcomes with regards to late lumen loss at