Press Releases and Statements

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 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

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

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

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

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