Commitment to Evidence-Based Medicine
As new technologies continue to impact healthcare outcomes and costs, evidence-based medicine and peer-reviewed clinical publications have become increasingly important. Evidence-based medicine relies on the results of clinical trials that study treatment options on a sampling of patients. The results or evidence help doctors, hospitals and governments to decide how to best care for patients. At Intuitive Surgical, our highest priority is and always has been to provide patient benefit by creating products that in a surgeon’s hands are safe, effective and minimally invasive.
Intuitive Surgical tracks the creation and publication of peer-reviewed publications related to the da Vinci® Surgical System. The current library includes PubMed and Scopus-indexed publications that represent many surgical specialties; the vast majorities were researched and written independent of Intuitive. The da Vinci clinical library is increasing at a rate of over 100 publications per month.
Level of Evidence of Peer-Reviewed Publications
Since 1998, over 7000 peer-reviewed publications have appeared in various clinical journals on da Vinci Surgery. The table below summarizes the level of scientific evidence for the clinical publications related to da Vinci Surgery. These levels of evidence are adapted from the March 2009 Centre for Evidence Based Medicine levels of evidence.
|LEVEL||DESCRIPTION||New in September||Total|
|Ia||Systemic reviews of randomized controlled trials||2|
|1b||Randomized controlled trials||12|
|1c||Randomized controlled trials for robotic technique studies||1||15|
|IIa||Systematic reviews of only comparison studies and Independent database population studies||2||73|
|IIb||Prospective non-randomized studies and RCTs with N<20||1||112|
|IIIa||Systematic reviews of mixed studies (comparison and single arm)||2||43|
|IIIb||Retrospective non-randomized studies and prospective comparison studies with N<20||30||771|
|IVb||Single arm studies and retrospective comparison studies with N<20||34||1716|
|Level V||Case reports, Animal and Cadaver studies, Expert Opinion and Editorials||86||4223|
Intuitive Surgical is pleased to highlight a bibliography of high level of evidence (level Ia, Ib and IIa) vs open surgery.
Links to featured publications supporting the clinical effectiveness of da Vinci Surgery by specialties are listed below, as well as Level of Evidence definitions.
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 875634 Rev B 10/13