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 Rutherford Class 2-4 disease. Patients were randomized 1:1 to either the Passeo-18 Lux DCB or In.Pact Admiral DCB for the treatment of stenotic, non-stented restenotic or occlusive lesions in the femoropopliteal artery. Baseline patient and lesion characteristics were comparable across both arms. As presented at Paris Vascular Insights in November 2023, the rate of clinically driven target lesion revascularization (CD-TLR)
BIOTRONIK is pleased to announce the availability of an expanded Maximum Allowed Diameters (MAD) range for the Orsiro® Mission Drug Eluting Stent (DES). Diameters 2.25mm to 3.00mm of the Orsiro Mission DES can now be extended up to 4.0mm, while diameters 3.5mm and 4.0mm can reach up to 5.0mm.This new MAD expansion follows the approvals from CE, FDA, and Health Canada obtained in the past months. This update reflects a global effort for the Orsiro Mission stent technology to match contemporary Percutaneous Coronary Intervention (PCI), enabling practitioners to optimize vessel apposition and conform to tapered anatomies.Subsequently to these approvals, an updated labelling, additionally to the modified Instructions for Use (IFU), will provide further guidance to practitioners.Always consult the Instructions for Use specific to your country when applying the Maximum Allowed Diameters (MAD).More information on Orsiro® Mission DES here.-END-Disclaimer: Orsiro and Orsiro Mission are trademarks or registered
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
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
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 were enrolled and treated either with Coroflex ISAR DES (n=559) or Orsiro DES (n=1,449). The study outcomes were published in Circulation1. In the presented post-hoc analysis out of a propensity score-matched population, results have shown that2: Dr. Kim also shared additional findings from the post-hoc analysis of the clinical performance of the two devices following either 3- or 12
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 into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The multifunctional system will be featured in the first symposium focused on the Oscar catheter at LINC 2023, with presentations from Drs. Koen Deloose, Peter A. Schneider, Ralf Langhoff, and Mariano Palena on Wednesday, June 7 at 12:30 PM in Main Arena 1 during the session “Versatility Without Compromise: The PAD Workflow of the F
