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 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
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
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
Our technologies enable physicians to provide highly effective therapies to patients suffering from cardiovascular and endovascular diseases. In the field of electrophysiology, BIOTRONIK offers state-of-the-art solutions that diagnose and treat patients with cardiac arrhythmias.
Personal radiation protection devices used to protect from harmful ionizing radiation are sometimes unpractical and difficult to use, resulting in unprotected body parts. Texray AB (Sweden) have invented a revolutionizing novel material platform with a woven textile technology. The essence of the textile is the attenuating capacity which protects medical staff from potentially harmful radiation. With that innovation, we enable unparalleled comfortability with pliable and breathable designs. Enabling medical staff to stay focused, highly protected and with peace of mind in the cathlab and operation room.
