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Current situation and overview of resorbable magnesium scaffolds: a perspective for overcoming the remaining issues of polymeric bioresorbable scaffold.

Cardiovasc Interv Ther

December 2024

Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya-ku, Saitama, Saitama, 330-8503, Japan.

Bioresorbable scaffolds (BRS) were developed as an innovative solution to overcome the limitations of metallic stents. While polymeric BRS initially demonstrated comparable clinical outcomes to drug-eluting stent (DES) in clinical trials, subsequent large-scale studies revealed that patients implanted with polymeric BRS experienced higher rates of scaffold thrombosis (ScT) and target lesion failure compared to those with metallic stents. Resorbable magnesium scaffolds (RMS) have emerged as a promising alternative owing to magnesium's natural degradability and favorable mechanical properties.

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Introduction: Deep, second- and third-degree burn injuries may lead to irreversible damage to the traumatized tissue and to coagulation or thrombosis of the microvessels, further compromising wound healing. Engineered, morphologically gradient drug-eluting nanofiber dressings promote wound healing by mimicking tissue structure and providing sustained drug delivery, which is particularly beneficial for wound management.

Methods: This study exploited a resorbable, radially aligned nanofiber dressing that provides the sustained gradient release of metformin at the wound site using a pin-ring electrospinning technique and a differential membrane-thickness approach.

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Aims: This preclinical study aimed to establish optical coherence tomography (OCT)-derived parameters that could be used in the clinical setting for assessing strut degradation in the third-generation drug-eluting resorbable magnesium scaffold (DREAMS-3G), and characterize the comparative degradation profile against its precursor device (Magmaris scaffold).

Methods And Results: Twelve DREAMS-3G and 10 Magmaris scaffolds were implanted in juvenile pigs, and OCT images obtained at baseline and follow-up (6 or 12 months). Strut degradation was assessed by planimetric analysis and compared with OCT-derived indices to validate their diagnostic accuracy.

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Article Synopsis
  • The BIOMAG-I study evaluated the first-in-human resorbable magnesium scaffold (DREAMS 3G) and showed positive outcomes for clinical results and late lumen loss after 12 months.
  • The current substudy looked into vascular healing parameters using optical coherence tomography (OCT) and intravascular ultrasound (IVUS), focusing on aspects like strut visibility and neointimal growth.
  • Results from 56 patients indicated that almost all scaffold struts became invisible by 12 months, with a favorable vascular healing response, including a significant decrease in protruding neointimal tissue.
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