BIOTRONIK announced today the enrollment of the first patient in the BIOMAG-II trial aiming to evaluate the safety and clinical performance of its new-generation resorbable magnesium scaffold (RMS), Freesolve™, compared to a contemporary drug-eluting stent (DES). "We are delighted to enroll the first patient in the BIOMAG-II trial, which may play a critical role in helping establish resorbable metallic scaffolds as part of clinical practice in the future and I am particularly encouraged by the implantation results of the Freesolve resorbable magnesium scaffold," said Dr. Juan F. Iglesias, HUG - University Hospital Geneva in Switzerland. "Resorbable scaffolds have shown potential in reducing long-term adverse events compared to DES, marking a significant advancement in vascular intervention. We finally have a scaffold that delivers on its promise." The BIOMAG-II trial is a prospective, international multi-center randomized-controlled study spanning 21 countries across Europe and the Asia-Pacific region
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 technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the program is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment and review while maintaining regulatory standards for pre-market approval
BIOTRONIK, a global leader in cardiovascular, endovascular, and neuromodulation solutions, today announces the launch of BIOMAG-LL, a pre-market trial focused on confirming the safety and clinical performance of Freesolve® Resorbable Magnesium Scaffold (RMS), for the treatment of long de novo lesions in native coronary arteries.The BIOMAG-LL is a prospective, international, multi-center, single arm pre-market study that will enroll 100 patients in Europe with de novo coronary artery stenosis and long lesions. Given that the Freesolve RMS is already CE-certified for shorter lesions, the BIOMAG-LL study will evaluate its effectiveness in longer lesions with new device sizes including now 35 mm and 40 mm scaffold lengths to support a broader market release. "We are pleased to introduce the BIOMAG-LL trial as a pre-market study with a particular focus on treating longer coronary lesions," says Prof. Flavio Ribichini, Interventional Cardiologist and Director of the Division of Cardiology at the Universi
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
Indicated for de novo coronary artery lesionsa SupportResorbable coronary scaffolds widen coronary artery stenoses and provide temporary vessel support. Thereby, scaffolds enable unobstructed blood flow in the coronary arteries with low rates of stent thrombosis (ST) and target lesion revascularization (TLR).ResorbBy degrading after fulfilling their scaffolding function, they offer all options of future therapies.
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 Netherlands, and Luxembourg with Rutherford 2-5 disease and at least two centimeters of healthy vessel segment between lesions in the popliteal artery and lesions in the distal superficial femoral artery. All patients were treated with the Passeo-18 Lux DCB. The bail-out stenting rate was 14%. At 24 months: “We face a scarcity of data evaluating endovascular therapy for isolated popliteal artery lesions, known
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
