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
Facilitate trapping of OTW devices with Guidion Short!1Enable trapping techniques of OTW devices in combination with a guide extension catheter.1 Its 15 cm distal shaft is designed to optimize trans-radial approach.1
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 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 announces the CE approval and launch of Freesolve™ Resorbable Magnesium Scaffold (RMS). This third generation RMS has been engineered to provide optimized vessel support, yet achieves magnesium resorption within 12 months.1 The new Freesolve RMS is a groundbreaking vascular advancement based on reliable clinical evidence. Recent BIOMAG-I trial data highlights an exceptional 99.3% magnesium strut degradation 12 months after implantation2, consistent performance, regardless of lesion characteristics, and restoration of vasomotion.3"Having closely observed the evolution of resorbable magnesium scaffolds, the Freesolve RMS achieves a 99.3% resorption rate at 12 months and provides better scaffolding than its predecessors," said Prof. Michael Haude, Rheinland Klinikum, Neuss, Germany. "The enhanced properties of the Freesolve RMS can establish a true alternative to DES, benefitting from the advantages of a resorbable device while maintaining a reliable and predictable outcome with the long-term sa
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 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 announces the FDA 510(k) clearance and CE mark of its Oscar® (One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter. Physicians in the U.S. have already used the novel device in more than 70 cases. As indicated per Instructions for Use, Oscar is intended for percutaneous transluminal interventions in the peripheral vasculature. The device was developed to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The Oscar peripheral multifunctional catheter is comprised of three user-adjustable components: The Oscar system will be available in 11 total size configurations with either 0.014”/4F or 0.018”/6F guidewire/introducer sheath compatibility. This may massively reduce stock units required compared to a standard PTA balloon. Additional standalone Oscar PTA balloons are also available separately to be used with the Oscar support catheter. The Oscar support catheter and dilator are used in tandem to enable
