University Hospital, Cleveland, Ohio 44106, USA.
J Neurointerv Surg. 2010 Dec;2(4):341-4. doi: 10.1136/jnis.2010.002600.
The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application.
A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial.
A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not.
Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.
本研究旨在评估该设备的上市后初始经验，并将其与用于支持 510k 申请的 Penumbra 关键性试验进行比较。
对 7 个国际中心的 157 例连续接受 Penumbra 系统治疗的患者进行回顾性病例分析。主要终点是靶血管再通（TIMI 评分 2 或 3）、定义为改良 Rankin 量表（mRS）评分≤2 的良好功能结局以及程序严重不良事件的发生率。结果与 Penumbra 关键性试验进行了比较。
共治疗 157 支血管。入组时的平均基线值为：年龄 65 岁，NIHSS 评分为 16。使用 Penumbra 系统后，与关键性试验中报告的 82%相比，87%的治疗血管再通至 TIMI 2（54%）或 3（33%）。157 例患者中报告了 9 例程序严重不良事件（5.7%）。全因死亡率为 20%（32/157），90 天随访时 mRS≤2 的比例为 41%，而关键性试验中仅为 25%。成功通过 Penumbra 系统再通的患者的结局明显好于未再通的患者。
Penumbra 系统的上市后初始经验表明，该设备的再通率和安全性与关键性试验中报告的结果相当。然而，具有良好功能结局的患者比例高于预期。
