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Freesolveᵀᴹ (暂仅有CE批准）
适用于冠状动脉原位原发狭窄性病变a
支撑
可吸收支架可扩张狭窄的冠状动脉，并提供临时的血管支撑。通过支架的支撑恢复冠脉内血供，同时降低支架血栓形成 (ST) 和靶病变血运重建 (TLR)的发生率。
吸收
支架在完成其支撑功能后会降解吸收，为后续治疗保留所有的选择可能性。
产品亮点
输送性更好5
更强的血管支撑6,7
12个月后完成镁合金的吸收8
经证实的临床安全性及有效性2,3
输送性更好5
更强的血管支撑6,7
吸收过程稳定可预测⁶
所有支架梁等量吸收6
支架梁始终保持形状匀称6
长达三个月的血管支撑6,7
12个月后完成镁合金的吸收8
>99% 支架梁 12 个月时已不可见8
经证实的临床安全性及有效性2,3
BIOMAG-I 首个人体研究 (FIH) trial3
产品概况
Freesolveᵀᴹ
新的钽标记，更好的可视性
薄壁
BIOlute® 活性涂层
BIOmag® 专利镁合金
产品参数
| 支架 | |||||
|---|---|---|---|---|---|
| 支架材料 | 专利 BIOmag® 镁合金 | ||||
| 支架梁厚度 | ø 2.5 mm: 99 μm; ø 3.0/3.5 mm: 117 μm; ø 4.0 mm: 147 μm |
||||
| 最大扩张直径 | 标称直径 + 0.6 mm | ||||
| 标记 | 两端各有一个椭圆形钽标记 | ||||
| 活性涂层 | BIOlute® 可吸收左旋聚乳酸 (PLLA) 洗脱莫司类药物 | ||||
| 输送系统 | |||||
| 导管类型 | 快速交换 | ||||
| 工作长度 | 140 cm | ||||
| 导引导管（推荐） | 6F | ||||
| 通过外径 | ø 2.5 mm ≤ 1.3 mm; ø 3.0-4.0 mm ≤ 1.4 mm | ||||
| 导丝直径 | 0.014” | ||||
| 命名压 (NP) | 10 atm | ||||
| 额定爆破压 (RBP) | 16 atm | ||||
血管尺寸
| 支架直径 (mm) (SD) |
参考血管直径 (mm) (RVD) |
|---|---|
| 2.50 | 2.50 - 2.70 |
| 3.00 | 2.70 - 3.20 |
| 3.50 | 3.20 - 3.70 |
| 4.00 | 3.70 - 4.20 |
顺应性表
| 球囊直径 (mm) | ||||
|---|---|---|---|---|
| ø 2.50 | ø 3.00 | ø 3.50 | ||
| 命名压 (NP) |
atm** 直径 (mm) |
10 2.52 |
10 3.04 |
10 3.54 |
| 额定爆破压 (RBP) | atm** 直径 (mm) |
16 2.72 |
16 3.29 |
16 3.79 |
| *1 atm = 1.013 bar | ||||
订货信息
| 支架直径 (mm) | 支架长度 (mm) | ||||
|---|---|---|---|---|---|
| 13 | 18 | 22 | 26 | 30 | |
| 2.50 | 443103 | 443104 | 443105 | - | - |
| 3.00 | 443108 | 443109 | 443110 | 482156 | 443111 |
| 3.50 | 443113 | 443114 | 443115 | 482157 | 443116 |
| 4.00 | 443118 | 443119 | 443120 | 482158 | 443121 |
下载和相关链接
Downloads
相关链接
媒体
KOL 采访
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References
Target Lesion Failure (TLF) is a composite of Target-Vessel Myocardial Infarction (TV-MI), clinically-driven Target Lesion Revascularization (CD-TLR) and Cardiac Death. *99.3% resorbed at 12 months (markers are not resorbable), based on clinical data; **based on QCA paired data. a. Indications as per IFU; b. BIOMAG-I case in normal cine projection, courtesy of Prof. Michael Haude, Rheinland Klinikum Neuss GmbH, Lukaskrankenhaus, Neuss, Germany; c. Xience Sierra DES (Abbott); d. Angiographic and OCT Analyses derived from two different BIOMAG-I cases, courtesy of Prof. Michael Haude, Rheinland Klinikum Neuss GmbH, Lukaskrankenhaus, Neuss, Germany; e. The 4P protocol was respected.
1. IIB Benchtest data, BIOTRONIK data on file; 2. Haude M. et al., the Lancet eClinicalMedicine 2023;59: 101940; 3. Haude, M. et al., EuroIntervention 2023;19:1-1 published online May 2023; 4. Seguchi M et al. OCT-Analysis 12M, presented at ESC 2023; 5. BIOTRONIK data on file, IIB Benchtest data: Freesolve in comparison to BIOTRONIK Orsiro Mission and Abbott Xience Sierra; 6. Based on pre-clinical data, Seguchi, M. et al., EuroIntervention 2023;18-online publish-ahead-of-print January 2023; 7. BIOTRONIK data on file, in comparison to predecessor device; 8. Based on intravascular OCT analysis of the BIOMAG-I trial presented by Dr. M. Seguchi at ESC 2023; 9. BIOTRONIK data on file; 10. Byrne, RA. et al., Eur Heart J 2015;36:2608-2620; 11. Haude M., et al. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. Eur Heart J. 2016;37:2701-9. 12. BIOMAG-I: two-year clinical outcomes of the resorbable magnesium Scaffold-DREAMS 3G, Moderated e-Poster presented by Prof. M. Haude at EuroPCR 2024.
BIOSOLVE-II and BIOMAG-I based on Kaplan-Meier failure estimate analysis.
BIOlute, BIOmag, BIOMAG, BIOSOLVE, Orsiro, Orsiro Mission, Magmaris & Freesolve are trademarks or registered trademarks of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owner.