Biotronik has enrolled the first patient in its BIOMAG-II trial, which will evaluate its new-generation Freesolve resorbable magnesium scaffold (RMS) against a contemporary drug-eluting stent (DES).

Biotronik已将第一名患者纳入其BIOMAG-II试验，该试验将针对当代药物洗脱支架（DES）评估其新一代Freesolve可再吸收镁支架（RMS）。

The BIOMAG-II international study will span 21 countries in the Europe and Asia-Pacific region. It has an enrollment target of 1,859 patients with de novo coronary in-stent restenosis. The study’s primary endpoint is target lesion failure (TLR) rate at 12 months.

BIOMAG-II国际研究将跨越欧洲和亚太地区的21个国家。它的登记目标是1859名新发冠状动脉支架内再狭窄患者。该研究的主要终点是12个月时的靶病变失败率（TLR）。

Follow-up visits will occur at one, six, and 12 months, then annually for up to five years post-procedure.

随访将在一个月，六个月和十二个月进行，然后在手术后五年内每年进行一次。

'We are delighted to enroll the first patient in the BIOMAG-II trial, which may play a critical role in helping establish resorbable metallic scaffolds as part of clinical practice in the future and I am particularly encouraged by the implantation results of the Freesolve resorbable magnesium scaffold,' said Dr.

“我们很高兴招募第一位患者参加BIOMAG-II试验，这可能在帮助建立可吸收的金属支架方面发挥关键作用，作为未来临床实践的一部分，我对Freesolve可吸收镁支架的植入结果特别感到鼓舞，”Dr。

Juan F. Iglesias, HUG - University Hospital Geneva in Switzerland. 'Resorbable scaffolds have shown potential in reducing long-term adverse events compared to DES, marking a significant advancement in vascular intervention. We finally have a scaffold that delivers on its promise.'.

瑞士日内瓦胡格大学医院的胡安·F·伊格莱西亚斯（JuanF.Iglesias）与DES相比，可再吸收支架已显示出减少长期不良事件的潜力，标志着血管干预取得了重大进展。我们终于有了一个兑现承诺的脚手架。”。

According to Biotronik, previous BIOMAG-I study results showed excellent outcomes regarding late lumen loss and TLF at six and 12 months. OCT imaging confirmed that Freesolve struts aren’t visible anymore at 12 months after implantation, and the magnesium is fully resorbed.

据Biotronik称，之前的BIOMAG-I研究结果显示，在6个月和12个月时，晚期管腔丢失和TLF的结果良好。OCT成像证实，植入后12个月，Freesolve支柱不再可见，镁被完全吸收。

Freesolve’s U.S. investigational device exemption (IDE) study and other international studies are in the preparation phase, the company said.

该公司表示，Freesolve的美国研究设备豁免（IDE）研究和其他国际研究正处于准备阶段。

“The BIOMAG-II study marks an exciting pivot point in how we treat patients with coronary artery disease, aiming to highlight the safety and effectiveness of our Freesolve resorbable magnesium scaffold. With solid clinical evidence at our core, we're dedicated to introducing innovative solutions that truly make a difference and enable patients to live an implant-free future,” said Prof.

“BIOMAG-II研究标志着我们如何治疗冠状动脉疾病患者的一个令人兴奋的支点，旨在强调我们的Freesolve可再吸收镁支架的安全性和有效性。我们的核心是坚实的临床证据，我们致力于引入创新解决方案，真正发挥作用，使患者能够过上无植入物的未来，”教授说。

Dr. Georg Nollert, VP medical affairs, Vascular Intervention at Biotronik..

Biotronik血管介入医学事务副总裁Georg Nollert博士。。

Earlier this year, the company earned U.S. Food and Drug Administration (FDA) breakthrough status for Freesolve’s use below-the-knee (BTK).

今年早些时候，该公司因Freesolve膝下使用（BTK）获得美国食品和药物管理局（FDA）突破性地位。