Enitra 8 CRT pacemakers take CRT a step further than implantation and therapy, enabling unique patient care with full-body MR conditional, wireless systems supported by timesaving remote monitoring and unique physiological rate adaptation. For optimal support along the CRT healthcare journey, the Enitra 8 CRT-P series offers LV VectorOpt, BIOTRONIK Home Monitoring®, MRI AutoDetect and CLS. Empowering CRT — Unique Patient Care Opportunities Beyond Implantation and Therapy.
Evity 8 CRT pacemakers take CRT a step further than implantation and therapy, enabling unique patient care with full-body MR conditional, wireless systems supported by timesaving remote monitoring and unique physiological rate adaptation. For optimal support along the CRT healthcare journey, the Evity 8 CRT-P series offers LV VectorOpt, BIOTRONIK Home Monitoring®, MRI AutoDetect and CLS. Empowering CRT — Unique Patient Care Opportunities Beyond Implantation and Therapy.
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 DES. No cases of myocardial infarction (MI), cardiac death, or definite/probable scaffold thrombosis were reported.1 “At this two-year time point, the Freesolve RMS with its new Magnesium alloy which allows for increased radial strength, showed again excellent clinical and safety,” said Prof. Michael Haude, Rheinland Klinikum, Neuss, Germany. “With this highly competitive device, we're advancin
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 endpoint, major adverse events (MAE) at 12 months, was met with a 3.5% rate of MAE1, significantly non-inferior to the historical control threshold (14%). MAE included device- or procedure-related death within 30 days post-index procedure, clinically driven target lesion revascularization (cd-TLR) and major index limb amputation up to 12 months post-index procedure.At 12 months, freedom from cd-TLR was 98.0%, primary paten
BIOTRONIK, a global leader in cardiovascular, endovascular, and neuromodulation solutions, is pleased to announce today the approval of two new indications for the Orsiro® Mission Drug-Eluting Stent (DES): One-month Dual Antiplatelet Therapy (DAPT) for High Bleeding Risk (HBR) Patients: Allows practitioners to offer personalized, shorter DAPT durations to their patients at high risk of bleeding events, in accordance with the most recent guidelines. Calcified Lesions Treatment: Allows practitioners to target more complex lesions with moderate or severe calcification. These new indications complement the recent global regulatory approval of the Orsiro® Mission DES for an increased maximum allowed diameter (MAD) post-dilation (Ø2.25-3.0 mm, MAD: 4.0 mm, Ø3.5-4.0 mm, MAD: 5.0 mm). Following these approvals, labelling including adapted Instructions for Use will become effective in the coming months, pending further national regulatory approvals. Please refer to the Instruc
Heart failure is a leading cause of hospitalizations, and each hospitalization reflects a deteriorating prognosis for the patient.1,2 Managing heart failure patients is complex and requires significant resources.3 Health care providers face the difficult tasks of reducing costs and preventing hospitalizations through early identification and care of at-risk patients.HeartInsight is a premium remote heart failure management solution that identifies patients at higher risk of decompensation early on. HeartInsight predicts heart failure hospitalizations — automatically and with high sensitivity — by combining multiple parameters into a single composite score, leading to one actionable alert. Industrywide it has the lowest false-alert rate and provides the earliest notifications of silent clinical changes that may lead to heart failure hospitalizations.4,5HeartInsight streamlines your work by accurately identifying at-risk patients early on, so you can proactively care for those who need y
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
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 six and 12 months,2,3 the additional analysis assessed the 12-months vessel healing profile. The analysis included patients from the multicenter BIOMAG-I trial who underwent OCT imaging pre- and post-procedure, at six and 12 months. One year after implantation of DREAMS 3G RMS, the strut degradation rate was 99.3% as measured by OCT.“We aimed to investigate the scaffold’s resorption process during the init
