Biotronik has earned U.S. Food and Drug Administration (FDA) breakthrough status for its Freesolve below-the-knee resorbable magnesium scaffold (BTK RMS).

Biotronik凭借其膝下可吸收镁支架（BTK RMS）的Freesolve获得了美国食品和药物管理局（FDA）的突破性地位。

The Freesolve BTK RMS is designed for patients with chronic limb-threatening ischemia (CLTI). CLTI is the most severe form of peripheral arterial disease (PAD), estimated to affect 11% of the 200 million people suffering from PAD globally. CLTI is associated with high rates of amputation and mortality as well as high care costs.

Freesolve BTK RMS专为慢性肢体威胁性缺血（CLTI）患者设计。CLTI是最严重的外周动脉疾病（PAD），估计会影响全球2亿PAD患者中的11%。CLTI与高截肢率和死亡率以及高护理成本有关。

The newly EU-launched Freesolve RMS for coronary artery lesions, based on the BIOmag magnesium alloy and Orsiro drug-eluting stent (DES) coating technology, provides safety, improved deliverability, and optimal performance and vessel support during and after implantation. It’s demonstrated 99.6% degradation of magnesium observed 12 months after implantation in coronary arteries, according to Biotronik.

基于BIOmag镁合金和Orsiro药物洗脱支架（DES）涂层技术，欧盟新推出的Freesolve RMS用于冠状动脉病变，可在植入期间和植入后提供安全性，改善可交付性，最佳性能和血管支持。据Biotronik称，植入冠状动脉12个月后观察到99.6%的镁降解。

The company believes these characteristics of the Freesolve RMS may be of value in BTK interventions, where vessel scaffolding is desired in the short-term to resist vessel recoil, yet ultimately leave the vessel implant-free.

该公司认为Freesolve RMS的这些特征可能在BTK干预中具有价值，在BTK干预中，短期内需要血管支架来抵抗血管反冲，但最终使血管植入物不受影响。

“BIOTRONIK's focus on vascular interventional excellence is evident in our strategic investments and persistent dedication to innovation,” said Dr. Jörg Pochert, president of Vascular Intervention at Biotronik. “Our efforts to expand therapeutic possibilities, underlined by the introduction of the Freesolve RMS for coronary artery disease treatment, will continue in the BTK indication with this groundbreaking innovation.”

BIOTRONIK血管介入总裁Jörg Pochert博士说：“BIOTRONIK对血管介入卓越的关注体现在我们的战略投资和对创新的持续奉献上。我们为扩大治疗可能性所做的努力，通过引入Freesolve RMS治疗冠状动脉疾病，将继续在BTK适应症中进行这项开创性的创新。”

“This breakthrough device designation for the Freesolve RMS for BTK treatment is a significant milestone in advancing treatment options. BIOTRONIK is committed to design our products to enhance the lives of patients,' added Ryan Walters, U.S. president at Biotronik. 'Our next generation RMS represents a leap forward over existing resorbable technology, incorporating technical innovations intended to address physicians' needs and optimize outcomes for patients suffering from CLTI.” .

BIOTRONIK美国总裁瑞安·沃尔特斯（RyanWalters）补充道：“Freesolve RMS用于BTK治疗的这一突破性设备设计是推进治疗选择的一个重要里程碑。BIOTRONIK致力于设计我们的产品，以改善患者的生活。我们的下一代RMS代表了对现有可再吸收技术的飞跃，结合了技术创新的意图ed旨在满足医生的需求，并优化患有CLTI的患者的预后。”

Last month, the company introduced the Micro Rx catheter, a rapid exchange microcatheter to enhance guidewire support during percutaneous coronary interventions (PCI).

上个月，该公司推出了Micro-Rx导管，这是一种快速交换的微导管，用于增强经皮冠状动脉介入治疗（PCI）期间的导丝支持。