Da Vinci Research and Outcomes
Meaningful evidence through clinical data and outcomes research
Intuitive supports the generation of high-quality clinical evidence through sponsored and collaborative research initiatives. We work with clinicians, hospitals and medical/surgical societies to uncover the benefits of Intuitive technologies while maintaining a patients-first mindset and help contribute to the body of knowledge about minimally invasive care.
Sponsored and collaborative research includes multicenter studies and key opinion leader partnerships. We also conduct early feasibility studies, product and indication approval studies, post-approval observational outcomes research, clinical registries, and analyses of real-world evidence (RWE) databases. Examining outcomes data helps generate evidence showing value to patients, surgeons, physicians, societies and other key stakeholders.
Our research includes but is not limited to studies across procedures, bariatrics, colorectal, general surgery, gynecology, thoracic, and urology. We also conduct platform specific studies for systems such as da Vinci SP and the Ion endoluminal system.
A large-scale systematic literature review and meta-analysis covering the period 2010-2022 is now available for your reading. These results are based on the COMPARE study and recently published in the Annals of Surgery. This meta-analysis of the global literature represents 22 countries, 7 different oncologic procedures including 230 peer-reviewed publications, covering over 1.1 million robotic cases with the da Vinci surgical systems, over 1 million lap/VATS cases and over 1.6 million open cases. This study highlights the clinical value of robotic-assisted surgery using the da Vinci surgical system and will help inform evidence-based decision making by physicians, health care providers, payors and policy makers.
The representative procedures presented under the IDE studies are not 510k cleared and the safety and effectiveness of the product for these listed procedures has not been established. These procedures are currently not available in the U.S.
Important safety information
Serious complications may occur in any surgery, including da Vinci surgery, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs and conversion to other surgical techniques which could result in a longer operative time and/or increased complications.
For summary of the risks associated with surgery refer to www.intuitive.com/safety.
For product intended use and/or indications for use, risks, cautions, and warnings and full prescribing information, refer to the associated user manual(s) or visit https://manuals.intuitivesurgical.com/market.
Individual outcomes may depend on a number of factors—including but not limited to—patient characteristics, disease characteristics, and/or surgeon experience.
Da Vinci Xi/X systems
The demonstration of safety and effectiveness for the representative specific procedures did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence), except for radical prostatectomy which was evaluated for overall survival, or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.
Da Vinci SP
The safety and effectiveness of this device for use in the performance of general laparoscopic surgery procedures have not been established. This device is only intended to be used for single port urological and general thoracoscopic surgical procedures and for transoral otolaryngology surgical procedures in the oropharynx for benign tumors and malignant tumors classified as T1 and T2 with the da Vinci EndoWrist SP Instruments and the da Vinci SP Surgical System (SP1098).
Ion endoluminal system
For risks, cautions, and warnings and full prescribing information, refer to the associated Ion System user manual(s). For summary of the risks associated with bronchoscopy refer to www.intuitive.com/safety.