Johnson & Johnson MedTech, a global leader in cardiovascular, orthopaedic, surgery and vision solutions, announced that the FDA  has approved the Ottava robotic surgical system investigational device exemption (IDE), which allows the clinical trial to begin at U.S. sites

心血管、骨科、外科和视觉解决方案的全球领导者强生医疗技术公司宣布，FDA已批准Ottava机器人手术系统研究设备豁免（IDE），该豁免允许临床试验在美国开始

The Company will now prepare clinical trial sites to receive OTTAVA systems, enroll patients, and begin surgical cases.

该公司现在将准备临床试验场地，以接收OTTAVA系统，招募患者并开始手术病例。

Johnson & Johnson MedTech is building on its global portfolio of surgical technologies to advance Ottava and help surgical teams and hospitals provide more patients with the benefits of robotic surgery. The system is designed to address unmet needs that persist in robotic surgery today, while driving choice and competition in an underpenetrated and high-growth market..

强生医疗科技（Johnson＆Johnson MedTech）正在建立其全球外科技术组合，以推进Ottava，并帮助外科团队和医院为更多患者提供机器人手术的好处。该系统旨在解决当今机器人手术中持续存在的未满足需求，同时在一个渗透不足且高速增长的市场中推动选择和竞争。。

“We are excited about reaching this important milestone and progressing our differentiated general surgery robotic platform for the benefit of patients and surgeons,” said Rocco De Bernardis, President, Ottava, Johnson & Johnson MedTech. “With approval to move to clinical investigation, our teams are focused on training clinical trial investigators and teams as they enroll patients and prepare for cases.”.

强生医疗技术公司Ottava总裁Rocco De Bernardis表示：“我们很高兴能达到这一重要里程碑，并为患者和外科医生的利益推进我们的差异化普外科机器人平台。”。“随着批准进入临床研究，我们的团队专注于培训临床试验研究人员和团队，因为他们招募患者并准备病例。”。

A differentiated approach to robotic surgery

机器人手术的差异化方法

The Ottava System is designed to set a new standard for the modern operating room (OR) and transform the surgical experience. The system’s unique unified architecture, surgical instrumentation powered by Ethicon expertise, and Johnson & Johnson MedTech’s digital ecosystem are intended to provide versatility to meet the needs of each patient’s care and each surgeon’s clinical approach..

Ottava系统旨在为现代手术室（OR）设定新标准，并改变手术体验。该系统独特的统一架构、由Ethicon专业技术支持的手术仪器以及强生医疗科技公司的数字生态系统旨在提供多功能性，以满足每位患者的护理需求和每位外科医生的临床方法。。

The Ottava system features four, low-profile robotic arms incorporated into the operating table that can be stowed underneath. This unified architecture allows for a compact footprint designed to support robotic, laparoscopic, hybrid, and open surgery with more working space for clinical teams.

Ottava系统具有四个轻巧的机械臂，这些机械臂被整合到手术台中，可以放在下面。这种统一的体系结构允许紧凑的占地面积，旨在支持机器人，腹腔镜，混合和开放手术，为临床团队提供更多的工作空间。

The system’s architecture supports clinically relevant features like “twin motion,” in which the table and robotic arms move together for intraoperative repositioning and multi-quadrant access without re-docking.

该系统的体系结构支持临床相关功能，如“双动”，其中桌子和机器人手臂一起移动，以进行术中重新定位和多象限访问，而无需重新对接。

The Ottava system will exclusively feature surgeon-trusted Ethicon instrumentation, designed for performance and precision and a more consistent experience between traditional laparoscopic and robotic procedures. Ethicon instruments designed for OTTAVA are backed by decades of innovation and market leadership in minimally invasive surgery, providing leading device-to-tissue and user-to-device interactions..

Ottava系统将专门配备外科医生信任的Ethicon仪器，专为性能和精度而设计，并在传统腹腔镜和机器人手术之间提供更一致的体验。为OTTAVA设计的Ethicon仪器得到了数十年微创手术创新和市场领先地位的支持，提供了领先的设备对组织和用户对设备的交互。。

Johnson & Johnson MedTech’s Polyphonic digital ecosystem will connect the portfolio across world-class surgical technologies, robotics, and surgical software while leveraging the global scale of Johnson & Johnson. In the future, Polyphonic will empower OTTAVA with data and advanced insights that will support clinical decision making, learning, and collaboration..

强生医疗科技公司的复调数字生态系统将连接世界级外科技术、机器人和外科软件的投资组合，同时利用强生的全球规模。未来，Polyphonic将为OTTAVA提供支持临床决策、学习和协作的数据和先进见解。。

The Ottava robotic system is under development and is not authorized to be marketed or sold in any market. For more information, visit: http://thenext.jnjmedtech.com/surgical-robotics.

Ottava机器人系统正在开发中，未经授权在任何市场上销售。有关更多信息，请访问：http://thenext.jnjmedtech.com/surgical-robotics.