Our broad range of products work to restore blood flow to vessels of the heart (coronary) and body (peripheral) that are narrowed or blocked. We produce a full range of stent systems, balloon catheters and guide wires for patients with coronary and peripheral artery disease.BIOTRONIK is a true innovator in the field, having introduced Pulsar, the world's first 4 F-compatible stent for treating long lesions, in 2009 and Orsiro, the industry's first hybrid drug-eluting stent, in 2011. Over the years our wide range of vascular intervention innovations include Orsiro DES, Resorbable Magnesium Scaffold, Drug Coated Balloon Catheters, Multifunctional Catheters and many more. Patient well being is our top priority and has been for 60 years.
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
BIOTRONIK's unique multifunctional catheter 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.
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 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
Prof. Michael Haude, BIOMAG-I Coordinating Clinical Investigator, presented the latest results of the BIOMAG-I clinical study at the Cardiovascular Research Technologies (CRT) meeting.1 At six months the angiographic and clinical data showed a low in-scaffold late lumen loss (LLL) rate and a good safety profile with no scaffold thrombosis. A low proportion of mal-apposed struts after implantation was observed, at six months struts were no longer discernable. The intravascular imaging documented a preservation of the scaffold area with a low mean neointimal area. Bioresorbable scaffolds have been developed to provide temporary mechanical support, while controlling neointimal proliferation over the vascular healing period and preventing long-term stent-related adverse events. DREAMS 3G, BIOTRONIK’s next generation drug-eluting resorbable Magnesium scaffold (RMS), is made of a proprietary Magnesium alloy and maintains a resorption time of 12 months. Compared to its predecessor DREAMS 2G, it offers unique be
BIOTRONIK announced the presentation of the 12-month results from the BIONETIC-I study this week at LINC 2024.The prospective, international, multicenter single-arm observational study evaluated the treatment of de novo, restenotic or occluded iliac lesions in 160 patients with Rutherford Class 2-6 peripheral artery disease using the Dynetic®-35 cobalt chromium balloon-expandable stent system. At baseline, 12.5% of enrolled patients had critical limb ischemia, 90% had calcified lesions (30.7% severe calcification), and there was an average of 85.5% stenosis in the target lesion.The primary endpoint, major adverse events (MAE) at 12 months, was met with a 3.5% rate of MAE1, significantly non-inferior to the historical control threshold (14%). MAE included device- or procedure-related death within 30 days post-index procedure, clinically driven target lesion revascularization (cd-TLR) and major index limb amputation up to 12 months post-index procedure.At 12 months, freedom from cd-TLR was 98.0%, primary paten
