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FDA Breakthrough Device Designation for Biotronik Freesolve Below-the-Knee Resorbable Magnesium Scaffold (RMS)

DAIC

The Freesolve BTK RMS is designed for individuals suffering from chronic limb-threatening ischemia (CLTI). Biotronik 's focus on vascular interventional excellence is evident in our strategic investments and persistent dedication to innovation”, said Dr. Jörg Pochert, President of Vascular Intervention at Biotronik.

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Dynamic Prognosis Prediction for Patients on DAPT After Drug?Eluting Stent Implantation: Model Development and Validation

Journal of the American Heart Association

BackgroundThe rapid evolution of artificial intelligence (AI) in conjunction with recent updates in dual antiplatelet therapy (DAPT) management guidelines emphasizes the necessity for innovative models to predict ischemic or bleeding events after drug‐eluting stent implantation.

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One-Year BIONETIC-I Study Results Show Safety and Effectiveness of Iliac Artery Treatment With BIOTRONIK’s Dynetic-35 Cobalt Chromium Balloon-Expandable Stent System

DAIC

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% stenosis in the target lesion.

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GE HealthCare and Medis Medical Imaging Announce Collaboration Focused on Non-Invasive Coronary Assessments to Help Advance Precision Care in Treatment of Coronary Artery Disease

DAIC

The benefits of QFR guidance are supported in a recent study that showed that a QFR-guided strategy of lesion selection for PCI improved two-year clinical outcomes, including reduction in myocardial infraction and ischemia-driven revascularization, when compared with standard angiography guidance alone.2

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FDA Approvals (July 2024 – January 2025): Advancements in Cardiorenal and Cardiometabolic Health 

Cardiometabolic Health Congress

August 2024 Approvals Minima Stent System (P240003) (Approval Date: August 28, 2024) The Minima Stent System is an expandable cobalt-chromium metal mesh tube to reopen blood vessels in neonates, infants, and children with Coarctation of the Aorta and Pulmonary Artery Stenosis, specifically designed to expand as younger patients grow.