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
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
BIOFLOW-DAPT one-year-data demonstrated non-inferiority and a good safety profile for the Orsiro® Mission drug-eluting stent (DES) compared to Resolute Onyx DES (p
In the first-in-human study BIOMAG-I, BIOTRONIK’s new-generation DREAMS 3G resorbable magnesium scaffold (RMS) showed significantly lower in-scaffold late lumen loss (LLL) than its predecessor at 12 months as well as excellent safety and efficacy. Prof. Michael Haude, BIOMAG-I Coordinating Clinical Investigator, presented the latest results in the late breaking trial session at the EuroPCR course.1 At one-year follow-up, BIOMAG-I data confirmed the excellent safety profile of DREAMS 3G RMS with a low target lesion failure rate of 2.6%. Neither cardiac death and myocardial infarction occurred, nor scaffold thrombosis was reported. After completion of the resorption, the in-scaffold LLL was 0.24±0.36 mm, comparable to contemporary drug-eluting stents (DES).2 “At the end of the scaffold resorption, at 12 months the data showed, that the DREAMS 3G scaffold has an excellent safety and efficacy profile”, said Prof Michael Haude, Rheinland Klinikum, Germany. “The late lumen loss is not just 38% better
BIOTRONIK announced the presentation of two-year results from the investigator-initiated BIOPACT RCT by Principal Investigator Dr. Koen Deloose at the Paris Vascular Insights 2023 congress. 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 24 months.1 The prospective, multicenter, core-lab adjudicated non-inferiority trial enrolled 302 patients in Austria, Belgium, France and Switzerland with Rutherford Class 2-4 disease. 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. Baseline patient and lesion characteristics were comparable across both arms. As presented at Paris Vascular Insights in November 2023, the rate of clinically driven target lesion revascularization (CD-TLR)
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
Los resultados del estudio MATRIX muestran que la alta precisión en la detección de los sistemas DAI DX con un solo cable para los episodios de FA (99,7 % para episodios ≥1 h), combinada con el potente rendimiento de transmisión de BIOTRONIK Home Monitoring®, permite la monitorización remota fiable de la FA subclínica recomendada por las guías. Los resultados se publicaron en Europace a principios de esta semana. 1MATRIX evaluó la utilidad del sistema DAI DX (detección de la señal auricular mediante un dípolo flotante integrado en el cable del DAI) para la monitorización remota de los episodios de alta frecuencia auricular (AHRE) y la evolución de su duración. Además, el estudio analizó las implicaciones clínicas de la detección y la evolución de los AHRE. El resultado del estudio debe interpretarse en el contexto de las directrices sobre la FA de 2020 de la Sociedad Europea de Cardiología, que recomiendan la monitorización remota de los AHRE detectados con disp
BIOTRONIK announced today the opening of its new Asia Pacific Manufacturing and Research Hub. The 20,000 m² site will serve as the company’s central hub in Asia-Pacific, with hundreds of employees working in manufacturing, quality, research & development (R&D), and sales and marketing. BIOTRONIK, founded in Berlin, Germany, in 1963 is a pioneer in implantable pacemakers, defibrillators, and vascular intervention for 60 years. BIOTRONIK’s presence in Singapore began in 2012, and in 2016, the company inaugurated its first manufacturing site, complementing its high-quality manufacturing sites in Germany, Switzerland and the United States. Now in 2023, the new facility has been designed with an emphasis on workspace agility for modern, optimized collaboration. The new site includes several spacious cleanrooms and laboratories developing and manufacturing state-of-the art Cardiac Rhythm Management (CRM) devices. “We are excited to be the first major manufacturer in the cardiac rhythm mana
