New-Gen Resorbable Magnesium Scaffold Freesolve Enters BIOMAG-II Randomized Controlled Trial (RCT) First Patient Enrolled in RCT comparing BIOTRONIK’s scaffold to a contemporary drug-eluting stent (DES)

Dr. Fadi Mansour performed the first Canadian implant of BIOTRONIK’s newest pacemaker and CRT-P generation earlier this year at the Centre Hospitalier de l'Université de Montréal. The patient received an Amvia Sky HF-T QP triple chamber pacemaker device. The first implant follows the full market release of BIOTRONIK’s newest family of pacemaker and CRT-P devices, featuring patient-centric technologies for better patient care and simplified workflows. “The Amvia Sky HF-T QP offers a significant number of advanced features, making it the most complete CRT-P on the market including streamlined

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

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, a leading global medical technology company specializing in innovative cardiovascular and endovascular solutions, proudly announces a multinational distribution partnership with Texray, the pioneering developer of a groundbreaking radiation protection textile. In this collaboration BIOTRONIK will distribute Texray's head and neck protectors starting in selected European and Middle Eastern countries. Both partners aim to raise awareness about the critical importance of radiation protection for healthcare professionals, who serve in environments where radiation exposure is an inherent

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

BIOTRONIK announced the CE approval and first European implant of its latest insertable cardiac monitor (ICM). The BIOMONITOR IV features artificial intelligence (AI) for false positive reduction. It is the only ICM on the market with premature ventricular and atrial contraction (PVC and PAC) discrimination capabilities, 1,2 as well as industry-leading signal quality and transmission success for highly reliable remote patient management. 3 False positive detections may take clinicians a considerable amount of time to review. That’s why BIOMONITOR IV features SmartECG, an intelligent system

BIOTRONIK has been granted Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for the Freesolve™ below-the-knee resorbable magnesium scaffold (BTK RMS). The Freesolve BTK RMS is designed for individuals suffering from chronic limb-threatening ischemia (CLTI). CLTI is the most severe form of peripheral arterial disease (PAD), estimated to affect 11% of the 200 million people suffering from PAD globally. CLTI is associated with high rates of amputation and mortality as well as high care costs. 1 To qualify for a Breakthrough Device Designation, a device

Following the recent CE approval of the Solia S lead 1 for LBBAP, BIOTRONIK proudly announces the world’s first and only complete CSP system, now fully CE-approved for Left Bundle Branch Area Pacing (LBBAP). 2 The BIOTRONIK CSP system comprises three proven components: Selectra 3D catheters offering exceptional handling 3, Solia S leads – the most popular choice of stylet-driven leads for LBBAP 4 providing enhanced stability 3, and the Amvia pacemaker family, the first and only family approved for LBBAP. 2 Notably, this groundbreaking system is the world’s first and only approved MR

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

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

BIOFLOW-DAPT one-year-data demonstrated non-inferiority and a good safety profile for the Orsiro ® Mission drug-eluting stent (DES) compared to Resolute Onyx DES (p<0.0001) in patients at high risk of bleeding receiving short dual antiplatelet therapy (DAPT). Prof. Marco Valgimigli presented the novel data in a late-breaking trial session at the European Society of Cardiology’s (ESC) Congress in Amsterdam. The results were published simultaneously in Circulation. BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study to assess the safety of one

The first implant in Europe of BIOTRONIK’s latest pacemaker and CRT-P generation was conducted in early August by Prof. Dr. Jan De Pooter at the University Hospital Ghent in Belgium. The patient who received an Amvia Sky dual chamber pacemaker device was a 68-year-old man suffering from paroxysmal AV-block strongly limiting his physical efforts. “The implantation went on straightforward and very smoothly,” commented Prof. De Pooter after the procedure. “LBBAP enables pacing in a very natural, physiological way, benefiting the patient by offering physiological pacing and minimizing the risk for

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

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

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

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

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

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

BIOTRONIK, a leading global medical technology company with 60 years of experience in developing trusted cardiovascular and endovascular solutions, announced today the latest addition to its cardiac rhythm management portfolio. "We are excited to have received CE mark for our newest technology – the world’s first pacemakers and CRT-Ps approved for left bundle branch pacing. Amvia Sky and Amvia Edge represent cutting-edge innovation and incorporate the latest cardiology trends," says Dr. Andreas Hecker, President CRM/EP at BIOTRONIK. In 1963, BIOTRONIK introduced the first German implantable

The company today announced U.S. Food and Drug Administration (FDA) approval for Prospera™, a spinal cord stimulation (SCS) system. The system features RESONANCE™, the first and only multiphase stimulation paradigm, paired with Embrace One™, a patient-centric care model that makes proactive care possible by offering automatic, objective, daily remote monitoring and ongoing management and support. 1 This approval marks the launch of the company’s new business segment, BIOTRONIK Neuro. Millions of people all over the world suffer from chronic intractable pain, a severe, constant, and

Results from the MATRIX study show that the high detection accuracy of DX single-lead ICD systems for atrial fibrillation (AF) episodes (99.7% for ≥ 1h episodes) in combination with the strong transmission performance of BIOTRONIK Home Monitoring ® allows for reliable guideline-recommended remote monitoring of subclinical AF. The findings were published in Europace earlier this week. 1 MATRIX evaluated the utility of the DX-ICD system (atrial signal detection via a floating dipole integrated in the ICD lead) for remotely monitoring atrial high-rate episodes (AHRE) and their duration

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 today that it has received CE approval for the Selectra 3D implant tools to include left bundle branch area pacing (LBBAP) in addition to His-bundle pacing (HBP). Commonly referred to as conduction system pacing (CSP) these two approaches have emerged as a physiologic pacing alternative to avoid dyssynchronous contraction of the heart which can induce various negative long-term effects for patients. 1-3 Approved in 2021 for HBP, Selectra 3D’s safety and effectiveness for CSP has been shown in over 10 studies with more than 1,000 patients. In the multi-center Belgium

BIOTRONIK announces the FDA 510(k) clearance and CE mark of its Oscar ® ( One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter. Physicians in the U.S. have already used the novel device in more than 70 cases. As indicated per Instructions for Use, Oscar is intended for percutaneous transluminal interventions in the peripheral vasculature. The device was developed to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The Oscar peripheral multifunctional catheter is comprised of three user-adjustable components: The