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First-in-Man Study of a Novel Peripheral Plaque Atherectomy Device.
J Clin Hypertens (Greenwich)
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Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
This first-in-man (FIM) study evaluated the feasibility and safety of a new peripheral plaque atherectomy system in patients with symptomatic lower extremity artery disease (LEAD). Ten patients with symptomatic LEAD (Rutherford class 2-5) were enrolled in a prospective, single-center study from March to April 2024. Patients aged 18-85 years with target lesions showing ≥70% stenosis and reference vessel diameters ≥1.
View Article and Find Full Text PDFFirst in man: PERCUTEK Tianyi® stent-graft greatly facilitated fenestration during thoracic aortic aneurysm endovascular repair.
Eur Heart J Case Rep
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Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai 20032, China.
Objective: To engineer an acellular mesh to reconstruct the urethra to replace the current surgical practice of using autologous tissue grafts. Cell based approaches have shown progress. However, these have been associated with high costs and logistical challenges.
View Article and Find Full Text PDFFirst-in-man study of a novel everolimus-coated balloon for the treatment of coronary in-stent restenosis.
Coron Artery Dis
March 2025
Department of Cardiology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Article Synopsis
- * The study included 51 patients and found a high safety rate, with 92.2% free from target lesion failure at 180 days and 90.2% at one year.
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Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation: The First-in-Man Experiences.
Korean Circ J
January 2025
Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University, Seoul, Korea.
Background And Objectives: Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR.
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