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 is proud to introduce the Micro Rx™ catheter, a novel rapid exchange microcatheter developed to easily enhance guidewire support during percutaneous coronary interventions (PCI). This cutting-edge device, exclusively distributed by BIOTRONIK, is manufactured by IMDS (Interventional Medical Device Solutions). Micro Rx catheter marks the fourth IMDS product BIOTRONIK has brought to the U.S., creating a compelling portfolio of devices which includes NHancer Rx, TrapIT, and ReCross catheters. The Micro Rx catheter features a reinforced distal shaft with a core wire between two layers of braids for optimal push transfer and a tapered tip with the market's smallest tip leading edge1 for high penetration force. Additionally, it features a thoughtfully engineered Proximal-End-Stop that allows for seamless integration of a guide extension catheter2 to gain additional support. The Micro Rx catheter is commercially available today in
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
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
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
Results from the MATRIX study show that the high detection accuracy of DX single-lead ICD systems for atrial fibrillation (AF) episodes (99.7% for ≥ 1h episodes) in combination with the strong transmission performance of BIOTRONIK Home Monitoring® allows for reliable guideline-recommended remote monitoring of subclinical AF. The findings were published in Europace earlier this week.1MATRIX evaluated the utility of the DX-ICD system (atrial signal detection via a floating dipole integrated in the ICD lead) for remotely monitoring atrial high-rate episodes (AHRE) and their duration progression. In addition, the study analyzed the clinical implications of AHRE detection and progression. The outcome of the study should be interpreted in the context of the 2020 European Society of Cardiology’s guidelines on AF which recommend remote monitoring of device-detected AHRE and provide further guidance depending on the AF burden along pre-specified duration strata.The study was led by Prof. Dr. Gerhard Hindricks, De
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
PTA (Peripheral Transluminal Angioplasty) balloon catheters are minimally invasive devices indicated to dilate stenoses in various peripheral arteries afflicted with peripheral artery disease (PAD). PTA balloons are designed to be inflated to their indicated diameter to restore blood flow in blocked arteries.
