FDA批准首款药物涂层血管成形术球囊

美国食品药品管理局（FDA）10月10日宣布，一款药物涂层血管成形术球囊导管已获准用于治疗外周动脉疾病（PAD），这是首个获准用于该适应症的医疗器械。

据FDA声明，该医疗器械名为Lutonix 035药物涂层球囊经皮腔内血管成形术导管（Lutonix DCB），由Lutonix公司生产，其外层涂以紫杉醇，“可有助于预防”血管成形术后再狭窄。“临床数据显示，Lutonix DCB在有助于预防动脉再狭窄方面比传统球囊血管成形术可能更为有效，”FDA医疗器械和放射健康中心科学副主任兼首席科学家William Maisel博士在声明中说道。

该批准令是基于3项临床试验和非临床测试结果：

• 一项纳入101例患者的欧洲随机多中心研究表明，6个月后，近72%的接受Lutonix DCB治疗的PAD患者无需进一步治疗，而接受传统球囊血管成形术治疗患者该比例为约为50%。

• 一项纳入476例患者的美国和欧洲单盲多中心随机研究显示，65%的随机接受Lutonix DCB治疗患者12个月时无再狭窄，而接受传统球囊血管成形术治疗患者该比例为约为53%。

• 一项目前正在美国和欧洲进行的纳入657例患者的单组安全性和有效性进一步评价研究，截止批准时 “未见意料之外的与医疗器械或药物相关的不良事件，”FDA说道。

上述研究还表明Lutonix DCB的安全性与传统球囊血管成形术相媲美。最常见主要不良事件包括额外干预措施、血流不佳导致的疼痛、未治疗的动脉狭窄、胸痛以及组织异常生长。

禁忌人群包括乳母、孕妇或计划怀孕妇女以及计划做父亲的男性。

FDA要求生产商开展2项批准后研究：目前正在进行的纳入657例患者的5年研究和1项旨在评价该器械对女性安全性和有效性的美国随机单组多中心研究。“这是因为该类人群与普通受试者的观察结果存在差异，”FDA称。

6月份召开的FDA专家小组会议对该产品进行了审评。

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By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network

A drug-coated angioplasty balloon catheter has been approved for treating peripheral artery disease, the first such device approved for this use, the Food and Drug Administration announced on October 10.

The device is the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB), manufactured by Lutonix; its outer surface is coated with paclitaxel, “which may help to prevent” restenosis after the angioplasty procedure, according to the FDA statement announcing the approval. “The clinical data show that Lutonix DCB may be more effective than traditional balloon angioplasty at helping to prevent further blockage in the artery,” Dr. William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the statement.

Approval was based on the results of three clinical trials and nonclinical testing:

• A randomized, multicenter study of 101 people in Europe, which found that after 6 months, no further treatment for PAD was needed in almost 72% of the patients treated with Lutonix DCB, compared with almost 50% of those treated with conventional balloon angioplasty.

• A single-blind, multicenter, randomized study of 476 people in the United States and Europe, which found that 65% of those randomized to treatment with Lutonix DCB had no restenosis at 12 months, compared with roughly 53% of those randomized to treatment with conventional balloon angioplasty.

• A single-arm, ongoing study that is further evaluating safety and effectiveness in 657 people treated with the device in the United States and Europe, which, at the time of approval, “show that there have been no unanticipated device- or drug-related adverse events,” the FDA said.

These studies also indicated that the safety of Lutonix DCB was comparable to conventional balloon angioplasty. The most common major adverse events included additional intervention, pain as a result of poor blood flow, narrowing of arteries that were not treated, chest pain, and abnormal growth of tissue.

Contraindications include women who are breastfeeding, pregnant, or plan to become pregnant; and men who plan to father children.

The company is required by the FDA to conduct two postapproval studies, the ongoing 5-year study of 657 patients, and a randomized, single-blind, multicenter study that will evaluate safety and effectiveness of the device in women in the United States, “due to differences in observed outcomes in this group as compared to outcomes for the general study population,” according to the FDA.

The device was reviewed at an FDA advisory panel meeting in June.