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 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
New results from the BIOMAG-I first-in-human trial demonstrated an excellent safety and efficacy profile for Freesolve®, BIOTRONIK’s third-generation resorbable magnesium scaffold (RMS) at three years follow-up. Prof. Dr. Michael Haude presented these new data at the EuroPCR 2025 conference in Paris.At the 36-month follow-up, the target lesion failure (TLF) rate remained at 3.5%, consisting of four cases of clinically driven target lesion revascularization (CD-TLR), of which only one event occurred beyond the resorption period of the scaffold. No cases of target-vessel myocardial infarction, cardiac death, or definite/probable scaffold thrombosis occurred.1BIOMAG-I is a prospective, multicenter, single-arm, first-in-human trial conducted in Europe. A total of 116 patients represented with single de novo lesions in up to two coronary arteries were included in the trial. Three-year data were available for 112 patients.“These outcomes show that Freesolve RMS is a viable therapy option combining both tempora
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
Today BIOTRONIK announces the enrollment of the first patient in the Leave Nothing Behind-Trial. The first implantation was performed by Dr. Mohamed Ayoub at the Heart and Diabetes Center North Rhine-Westphalia, Germany. The trial aims to demonstrate the non-inferiority of drug-coated balloons (DCB) or DCBs in combination with Resorbable Magnesium Scaffolds (RMS) compared to drug-eluting stents (DES) in chronic total occlusions (CTO) in percutaneous coronary interventions (PCI). The prospective, single-center, single-blind, randomized trial evaluates the efficacy of the Pantera® Lux® DCB and Freesolve® RMS compared to Orsiro® Mission* DES in 166 CTO patients. “We want to investigate whether treatment with DCBs ─ used alone or with Resorbable Magnesium Scaffolds as a bailout option ─ is non-inferior to drug-eluting stents in patients with chronic total occlusions,” summarized Principal Investigator Dr. Mohamed Ayoub, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, German
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
