According to GlobalData analysis, the global TAVR market is growing at a CAGR of 8.1% and projected to reach a valuation of almost $15bn by 2034. Image credit: Thx4Stock team via Shutterstock.

根据GlobalData的分析，全球TAVR市场正以8.1%的年复合增长率增长，预计到2034年将达到近150亿美元的估值。图片来源：Thx4Stock团队通过Shutterstock提供。

The US Food and Drug Administration (FDA) has cleared Caranx Medical’s TAVIPILOT Soft, an artificial intelligence (AI)-based guide software for use during Transcatheter Aortic Valve Implantation (TAVI) or replacement procedures (TAVR).

美国食品药品监督管理局 (FDA) 已批准 Caranx Medical 的 TAVIPILOT Soft，这是一款基于人工智能 (AI) 的引导软件，用于经导管主动脉瓣植入术 (TAVI) 或置换手术 (TAVR)。

The French company claims that TAVIPILOT Soft is the first solution of its kind, designed to simplify heart valve positioning and delivery by tracking real-time anatomical and instrument landmarks during implantation or replacement.

法国公司声称，TAVIPILOT Soft 是同类产品中的首个解决方案，旨在通过在植入或更换过程中跟踪实时解剖和器械标志来简化心脏瓣膜的定位和递送。

Caranx filed for TAVIPILOT Soft’s clearance with the

卡兰克斯已为TAVIPILOT软组织清除装置提交了申请。

FDA in January

一月的FDA

. The agency’s clearance for the software was based on a demonstration of the software’s feasibility during a live TAVI procedure on a porcine (pig) model. Caranx also filed a human factors engineering (HFE) validation by interventional cardiologists and cardiac surgeons at leading structural heart centres in Chicago and New York, and bench and simulation data in which Caranx demonstrated consistent valve-positioning accuracy of the software..

该机构对软件的批准是基于在猪模型上进行的一次现场TAVI手术中展示的软件可行性。Caranx还提交了由芝加哥和纽约领先的结构性心脏病中心的介入心脏病学家和心脏外科医生进行的人因工程（HFE）验证，以及工作台和模拟数据，其中Caranx展示了软件一致的瓣膜定位准确性。

According to Caranx, the complexity of TAVI/TAVR procedures means their application is currently limited to the most advanced cardiology centres. With its AI software, which is compatible with all cardiac imaging systems and TAVI heart valves currently on the market, the company hopes to democratise access and allow a broader range of cardiologists and cardiology centres to undertake TAVI/TAVR procedures..

据Caranx称，TAVI/TAVR手术的复杂性意味着其应用目前仅限于最先进的心脏病学中心。该公司希望通过其与所有心脏成像系统和当前市场上TAVI心脏瓣膜兼容的AI软件，实现技术普及化，使更广泛的心脏病学家和心脏病中心能够进行TAVI/TAVR手术。

Caranx founder Philippe Pouletty said: “Allowing a broader number of cardiologists and interventional cardiology centres to perform complex procedures, such as TAVI, with the Caranx AI-driven software and autonomous robot is at the heart of our mission of entrepreneurs and business builders to save lives and revolutionise medicine.”.

卡兰克斯创始人菲利普·普勒蒂表示：“让更广泛的心脏病学家和介入心脏病中心能够通过卡兰克斯人工智能驱动的软件和自主机器人执行诸如TAVI之类的复杂手术，是我们作为企业家和商业建设者拯救生命、革新医学使命的核心。”

Caranx is targeting an early market launch of TAVIPILOT Soft in the US by the end of 2025.

Caranx 计划在 2025 年底前在美国市场早期推出 TAVIPILOT Soft。

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According to GlobalData analysis, the global TAVR market is growing at a CAGR of 8.1% and projected to reach a valuation of almost $15bn by 2034.

根据 GlobalData 的分析，全球 TAVR 市场正以 8.1% 的年均复合增长率增长，预计到 2034 年将达到近 150 亿美元的估值。

Caranx CEO Jorgen Hansen commented: “This clearance confirms the potential of real-time guidance in TAVI and TAVR procedures to enhance precision and improve patient outcomes.”

Caranx首席执行官乔根·汉森评论道：“这一批准确认了在TAVI和TAVR手术中实时引导的潜力，可以提高精确度并改善患者预后。”

TAVIPILOT Soft is currently fed by annotated images including computed tomography, fluoroscopy, echocardiograms from over 5,000 patients. Caranx said it plans to continue refining TAVIPILOT Soft in the future to cover other cardiovascular indications including mitral and tricuspid valve replacements..

TAVIPILOT Soft 目前通过包括计算机断层扫描、透视、经胸超声心动图等超过5000名患者的注释图像进行数据输入。Caranx 表示，未来计划继续完善 TAVIPILOT Soft，以覆盖其他心血管适应症，包括二尖瓣和三尖瓣置换。

To further develop TAVIPILOT Soft, Caranx added that it is looking into collaborating with other cardiovascular companies under the aegis of Carvolympics, a yearly accelerator and competition the company has created with the aim to crowdsource the next generation of AI-driven, robotic-assisted solutions across structural heart interventions..

为了进一步开发TAVIPILOT Soft，Caranx补充道，公司正在考虑在Carvolympics的旗帜下与其他心血管公司合作。Carvolympics是该公司创建的年度加速器和竞赛项目，旨在众包下一代由人工智能驱动、机器人辅助的结构性心脏介入解决方案。