Clinical Evidence
Commitment to Evidence-Based Medicine
As individuals and agencies seek to understand the impact of new technologies on health-care outcomes and costs, evidence-based medicine and peer-reviewed clinical publications have become increasingly important. Evidence-based medicine is a systematic approach to clinical problem-solving. It is the accepted method for physicians and governments to determine best practices and is the foundation for Comparative Effectiveness Research (CER). CER compares available treatment options using a range of research methods.
Intuitive Surgical supports CER, particularly when all treatment modalities are considered for a given disease. We are actively collaborating on projects that aim to produce high-level evidence with a CER outcome. Intuitive Surgical also tracks the creation and publication of peer-reviewed publications on clinical uses of the da Vinci® Surgical System. The current library includes PubMed-indexed publications representing several surgical specialties ― the vast majority of which were researched and written independently of Intuitive.
The da Vinci clinical library is increasing at a current rate of approximately 100 publications per month. While some critics cite the lack of clinical evidence for the efficacy of da Vinci Surgery, the peer-reviewed literature is both deep and compelling across many clinical applications of surgical robotics.
Level of Evidence of Peer-Reviewed Publications
Since 1998, over 4000 peer-reviewed publications have appeared in various clinical journals on da Vinci Surgery. These include:
- Level 1 publications which report on randomized, controlled trials.
- Level 2 publications which report on non-randomized controlled trials, typically defined as prospective, pre-planned studies with predetermined eligibility criteria and outcome measures.
The table below summarizes the clinical publications relating to da Vinci Surgery that meet the higher level of evidence standard of level 1, 2a or 2b, as defined by guidelines from the Department of Public Health Services, King's College, London.
| LEVEL | DESCRIPTION | New in April | Total |
| Level 1 | Randomized control trial | 1 | 34 |
| Level 2a | Non-randomized prospective study including a comparison cohort | 6 | 153 |
| Level 2b | Non-randomized retrospective study including a comparison cohort | 10 | 719 |
| Lower level publications: | |||
| Level 3 | Single cohort (non-comparison) studies | 39 | 5388 |
| Level 4 | Case studies | 24 | |
| Level 5 | Opinion publications | 41 | |
| TOTAL | 121 | 6303 | |
Approximately 46% of these publications pertain to urologic surgery; 17% to cardiothoracic surgery; 13% to general surgery; 8% to gynecologic surgery; 7% to general surgery topics; 4% to pediatric surgery and 2% are on ENT. These studies include hundreds of surgeons and cover thousands of patients in dozens of countries.
Below are links to featured publications that support the clinical effectiveness of da Vinci® Surgery as used in a range of surgical specialties:
- Urology
- Gynecology
- General Surgery and TORS
- Cardiothoracic
- Other(GenRobotic/Pediatric/Training/Other)
Clinical Research for da Vinci® Practitioners
Clinical practitioners of da Vinci Surgery can perform detailed research from the world's largest collection of robotically-assisted surgery abstracts on the da Vinci Surgery Online Community: www.daVinciSurgeryCommunity.com.
This site is open to da Vinci practitioners and personnel only and requires free sign up. Access to the Clinical Research section of the site requires validation, which can take 1-2 business days.
Sign up now to access the da Vinci Surgery database.
To determine whether the FDA has cleared da Vinci Surgical System for use in a specific procedure, please refer to the Regulatory Clearance page.
PN 8756434 Rev A 12/11
