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
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
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
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, nor scaffold thrombosis was reported. After completion of the resorption, the in-scaffold LLL was 0.24±0.36 mm, comparable to contemporary drug-eluting stents (DES).2 “At the end of the scaffold resorption, at 12 months the data showed, that the DREAMS 3G scaffold has an excellent safety and efficacy profile”, said Prof Michael Haude, Rheinland Klinikum, Germany. “The late lumen loss is not just 38% better
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 enrolled 302 patients in Austria, Belgium, France and Switzerland with Rutherford 2-4 disease.1 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.1 The primary safety endpoint was a composite of freedom from device- and procedure-related death through 30 days post-index procedure
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 today announces the launch of the latest innovations in guide extension catheters: FlowGuide and Guidion Short. These new devices have been developed to offer enhanced support and to facilitate the delivery of devices during complex vascular interventions. The catheters introduce key elements, such as perfusion holes in the distal shaft of the FlowGuide catheter, and a transradial access and trapping friendly design for both new products. Through our collaboration with IMDS, the FlowGuide and Guidion Short catheters expand BIOTRONIK's portfolio of high-performance devices dedicated to complex PCI (percutaneous coronary intervention) such as the TrapIT, NHancer Rx, and ReCross. Developed and manufactured by IMDS (Interventional Medical Device Solutions), they are distributed by BIOTRONIK in selected countries. The nine circumferential perfusion holes* in the distal shaft of the FlowGuide catheter are designed to maintain optimal blood flow to distal vessels and side branches1, thereby reducing t
