C.R. Bard, Inc., 9409 Science Center Drive, New Hope, MN 55428, United States.
C.R. Bard, Inc., 9409 Science Center Drive, New Hope, MN 55428, United States.
Adv Drug Deliv Rev. 2017 Mar;112:78-87. doi: 10.1016/j.addr.2017.05.015. Epub 2017 May 27.
Local drug delivery of an anti-proliferative drug from balloon catheter systems to the site of arterial injury has been attempted repeatedly over the years with limited success in drug uptake and retention. Accessibility of the drug at the site is critical to combat the body's response to the procedural trauma of angioplasty. Recently, formulations have been designed which achieve delivery of therapeutic doses of the anti-proliferative drug paclitaxel to arteries with higher efficiency and longer tissue retention. These formulations succeed through formation of a drug reservoir in the artery wall enabling release after the initial angioplasty procedure. These formulations have become the cornerstone of several drug coated balloon (DCB) technologies which have found an initial, broad therapeutic application in the treatment of stenosis of the superficial femoral artery (SFA). DCBs achieve drug delivery while leaving no implant behind and represent a new class of combination products developed at the interface of engineering, chemistry and medical science. This review article summarizes the development of the LUTONIX® drug coated balloon catheter. The introduction of DCB technology has provided clinicians and patients with new SFA treatment options while ongoing clinical evidence in additional vascular beds is generated.
多年来，人们反复尝试通过球囊导管系统将一种抗增殖药物局部递送至动脉损伤部位，但药物摄取和保留的效果有限。药物在该部位的可及性对于对抗血管成形术的程序性创伤引起的身体反应至关重要。最近，设计了一些制剂，可更有效地将治疗剂量的抗增殖药物紫杉醇递送至动脉，并具有更长的组织保留时间。这些制剂通过在动脉壁中形成药物储库来实现，从而在初始血管成形术后释放药物。这些制剂已成为几种药物涂层球囊（DCB）技术的基石，这些技术在治疗股浅动脉（SFA）狭窄方面已初步得到广泛应用。DCB 在实现药物递送的同时不会留下任何植入物，代表了在工程、化学和医学科学交叉点开发的一类新型联合产品。本文综述了 LUTONIX®药物涂层球囊导管的发展情况。DCB 技术的引入为临床医生和患者提供了新的 SFA 治疗选择，同时正在其他血管床产生更多的临床证据。
