The findings suggest that using the platform is a safe and feasible approach to sample lung tissue.
SUNNYVALE, Calif., Nov. 02, 2017 (GLOBE NEWSWIRE) -- Results from the first clinical study evaluating a new flexible robotics platform under development by Intuitive Surgical were presented at the CHEST Annual Meeting on Wednesday. The findings suggest that using the platform is a safe and feasible approach to sample lung tissue.
Intuitive Surgical’s robotic-assisted, catheter-based technology is being designed to access hard-to-reach areas of the body through natural openings, like the mouth. When applied in the lungs, its aim is to enable early lung cancer diagnoses by accessing and sampling tissue from small nodules in difficult-to-reach areas.
This single-center study at Australia’s Royal Brisbane and Women’s Hospital was led by principle investigator, David Fielding, MD, a thoracic physician and Director of Bronchology, and co-investigator Farzad Bashirzadeh, MD, a respiratory and sleep physician at the hospital. The 30-patient study evaluated both the safety and feasibility of the platform.
In the study, a majority of the target nodules were smaller than two centimeters in diameter. In 29 of 30 cases, the pre-planned target area was reached and a sample suitable for assessment was obtained. Additionally, no device-related adverse events, or instances of pneumothorax or excessive bleeding occurred, suggesting a strong safety profile.
“I was able to reach nodules in the peripheral lung that I wouldn’t have been able to reach before,” said Dr. Fielding. “The robotic-assisted technology in sampling facilitates diagnosis at a stage in which most patients wouldn’t yet know that they have cancer. Early diagnosis should allow us to start care plans for patients earlier and offer curative treatments.”
The flexible robotics platform from Intuitive Surgical is still under development, not yet 510(k) cleared by the U.S. Food and Drug Administration and not for sale. The safety and effectiveness of this platform have not been established. The study was funded by Intuitive Surgical.
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets robotic-assisted technologies. The Company strives to make surgery more effective, less invasive and easier on surgeons, patients and their families.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the flexible robotics platform as a safe and feasible approach to sample lung tissue, the ability of platform application in the lungs to enable early lung cancer diagnoses, the strong safety profile of the platform, and enabling physicians to start care plans for patients earlier and offer curative treatments. These forward-looking statements are necessarily estimates reflecting the best judgment of our management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. These forward-looking statements should, therefore, be considered in light of various important factors, including, but not limited to, the following: the impact of global and regional economic and credit market conditions on healthcare spending; healthcare reform legislation in the United States and its impact on hospital spending, reimbursement and fees levied on certain medical device revenues; changes in hospital admissions and actions by payers to limit or manage surgical procedures; the timing and success of product development and market acceptance of developed products; the results of any collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships; procedure counts; regulatory approvals, clearances and restrictions or any dispute that may occur with any regulatory body; guidelines and recommendations in the healthcare and patient communities; intellectual property positions and litigation; competition in the medical device industry and in the specific markets of surgery in which we operate; unanticipated manufacturing disruptions or the inability to meet demand for products; the results of legal proceedings to which we are or may become a party; product liability and other litigation claims; adverse publicity regarding the Company and the safety of our products and adequacy of training; our ability to expand into foreign markets; and other risk factors under the heading “Risk Factors” in our report on Form 10-K for the year ended December 31, 2016, as updated by our other filings with the Securities and Exchange Commission. Statements using words such as “estimates,” “projects,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” “could,” “should,” “would,” “targeted” and similar words and expressions are intended to identify forward-looking statements. You are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this press release. We undertake no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.
PN 1042795-US Rev A 10/2017
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