Recap of SIR 2019

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With New Indication, Embosphere® Continues to Trailblaze After Two Decades on the Market

FDA现已清除FDA，用于栓塞血管的预期用途来控制外周脉管系统的出血和出血。作为第一次接受这种间隙的球形栓塞，这是一个用于锻造的长线首先的另一个指示，在最临床上研究和临床上验证的圆形栓塞，以一致和可预防的栓塞术语，巩固栓塞。

Embosphere was first developed at the Lariboisière Hospital in Paris, France, with initial clinical studies taking place in the late 1980s. Previous to Embosphere, standard embolic agents used for therapeutic embolization initially only included non-spherical polyvinyl alcohol (PVA) particles and gelatin sponge, but both products were seen to have shortcomings.

从本质上讲,non-spherical PVA particles vary in size. This irregularity could possibly lead to uncontrolled embolization as well as the clogging of microcatheters.1,2Gelatin sponge has been linked with more inflammatory reactions than spherical embolic agents and is often time-consuming to prepare, with uniformly sized particles also a challenge to obtain.2,3The desire and need for a better embolic agent led to the development of Embosphere Microspheres.

由三丙烯酸交联共聚物的专有制剂制成，扶余的球形形状模仿血管内腔的自然轮廓，允许“适合和填充”效果。此外，亲水表面防止导管内腔和脉管系统中的聚集。*

比较研究表明，对比具有较大的优势。首先，它是唯一圆形栓塞在所用颗粒的尺寸和闭塞动脉的直径之间具有直接相关性。1Competing embolics have no such correlation and have been shown to have higher in-vivo deformation ratesand therefore are unable to provide predictable embolization.1,4Data has also shown Embosphere Microspheres to compress up to 33%, helping to facilitate smooth microcatheter passage.5然后，这些微球在递送后返回到它们的陈述直径，有助于耐用和靶向结果。

Now, more than 20 years later, Embosphere is the most extensively studied and clinically utilized round embolic, having been proven in hundreds of thousands of procedures worldwide and in more than 220 peer-reviewed clinical articles.

A microsphere with unwavering performance and quality, Embosphere has still continued to innovate over the years. Starting in 1997, it was the first commercially available microsphere. In 2002, Embosphere was the first embolic agent packaged in a syringe and the first to receive US indication for子宫肌瘤栓塞(UFE). Fast forward to 2017, Embosphere was the first to receive US indication forprostatic artery embolization(PAE). And today we recognize the most recent first—its US indication for embolization to control bleeding and hemorrhaging in the peripheral vasculature.

These many firsts speak to Embosphere’s high level of quality and performance as well as reflect Merit Medical’s ongoing dedication to embolics and support for the minimally invasive therapies physicians provide.

Timeline of Embosphere - First Available, Most Studied, Embolization

参考

  1. Pelage, J., Laurent, A., Wassef, M., et al. (2002). Uterine artery embolization in sheep: Comparison of acute effects with polyvinyl alcohol particles and calibrated microspheres. Radiology, Aug;224(2):436-445.
  2. Worthington-Kirsch, R. (2008, Jun). Do particle size and type matter? Retrieved fromhttps://evtoday.com/2008/06/EVT0608_04.php?center=156
  3. Oh, J., Lee, H., Chun, H., et al. (2015). Evaluation of arterial impairment after experimental gelatin sponge embolization in a rabbit renal model. Korean J Radiol, Jan-Feb;16(1):133-138.
  4. Verret, V., Ghegediban, S., Wassef, M., et al. (2011). The arterial distribution of Embozene and Embosphere microspheres in sheep kidney and uterus embolization models. J Vasc Interv Radiol, Feb;22(2):220-228.
  5. Laurent, A., Beaujeux, R., Wassef, M., et al. (1996). Trisacryl gelatin microspheres for therapeutic embolization, I: Development and in vitro evaluation. AJNR Am J Neuroradiol, Mar;17(3):533-540.

*In-House Data