Intuitive Announces FDA Clearance of Revised da Vinci Xi and X Labeling on Radical Prostatectomy
Intuitive (NASDAQ: ISRG) announced FDA clearance for revised labeling of its da Vinci X and Xi systems, specific to radical prostatectomy. The revision is based on real-world evidence from 2007 to 2014, indicating similar five- to 10-year cancer survival rates for robotic-assisted and open surgeries. This collaboration involved the FDA, Aetion, and NEST, highlighting the potential of real-world data in regulatory science. The labeling change reflects these findings, affirming the non-inferiority of robotic-assisted surgeries in cancer treatment outcomes.
- FDA clearance for revised labeling of da Vinci X and Xi systems.
- Real-world evidence indicates similar five- to 10-year survival rates for robotic-assisted and open prostatectomy surgeries.
- Collaboration with FDA, Aetion, and NEST demonstrates the utility of real-world data.
- Study involved nearly 25,000 patients, enhancing data reliability.
- Potential for similar assessments in other cancer procedures, advancing regulatory science.
- The study timeframe (2007-2014) might limit relevance to current clinical practices.
- Labeling change only indicates non-inferiority, not superiority, which might limit market appeal.
The FDA clearance for revised labeling of the da Vinci X and Xi systems indicating non-inferiority in overall survival rates for robotic-assisted radical prostatectomy is a notable development. The use of real-world evidence (RWE) enhances the credibility of these findings, reflecting robust data over a significant period. This shows a strong alignment with evolving trends in medical device regulations, where RWE plays an increasingly pivotal role. The collaboration between Intuitive, the FDA and other entities underscores the potential benefits of such partnerships in advancing regulatory science.
Key Insight: The FDA’s acceptance of RWE signifies a shift towards more inclusive and pragmatic data evaluation methods, which could pave the way for similar future approvals. This might streamline the approval process, resulting in quicker access to innovative medical technologies.
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The market implications of this FDA clearance are significant. Intuitive Surgical has reinforced its position in the market by showing that its robotic-assisted surgery system’s results are on par with traditional methods. This could bolster investor confidence and potentially increase adoption rates among hospitals and surgical centers.
Key Insight: With a proven track record of safety and efficacy, the da Vinci systems become more appealing to institutions weighing the high initial costs against long-term benefits. Additionally, the labeling revision may prompt healthcare providers to consider robotic systems more seriously, leading to market expansion.
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From a clinical perspective, the confirmation of non-inferiority in overall survival for robotic-assisted radical prostatectomy provides reassurance regarding the da Vinci systems' efficacy. This can influence treatment decisions, reassuring both providers and patients about the viability of robotic surgery.
Key Insight: The data highlights the importance of technological advancements in surgical oncology. With reduced hospital stays and less invasive procedures, the quality of patient care can improve significantly. Moreover, this could signal a broader acceptance of robotic systems in other oncological procedures.
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FDA review of historic data shows patients who received robotic prostatectomies have overall cancer survival rates on par with open surgery
SUNNYVALE, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- Intuitive (NASDAQ:ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced today that the U.S. Food and Drug Administration (FDA) cleared a labeling revision for da Vinci X and Xi specific to radical prostatectomy. This clearance was based on real-world evidence (RWE) collected from 2007 to 2014 that demonstrates overall five- to 10-year survival following robotic-assisted radical prostatectomy is similar to non-robotic radical prostatectomy.
In a public-private collaboration, Intuitive worked with the FDA, healthcare analytics company Aetion, and the National Evaluation System for health Technology (NEST), utilizing its NEST Mark process to support the validity of the real-world data used in the labeling revision submission. This project demonstrated the utility of this type of collaboration in generating high-quality RWE to support marketing applications to the FDA and could allow for similar comprehensive long-term survival assessments for other cancer procedures, which helps advance regulatory science.
“We believe that many robotic procedures have advantages over traditional open surgery and laparoscopy for patients, care teams, and hospital customers—such as shorter hospital stays, fewer conversions, and less blood loss,” said Intuitive Chief Medical Officer Myriam Curet, M.D. “This is a significant step because it confirms non-inferiority for overall survival at 10 years for patients undergoing radical prostatectomy with the da Vinci surgical system.”
The labeling change applies specifically to the Precaution for Representative Uses statement for the da Vinci X and Xi systems. The previous precaution statement noted that the FDA did not review evaluation of outcomes related to the treatment of cancer. The revised version is as follows (changes in bold):
Precaution for Representative Uses
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.
Intuitive provided data from a retrospective cohort study using de-identified healthcare claims data from the Optum Clinformatics Data Mart to evaluate overall survival following radical prostatectomy via robotic-assisted surgery as compared to open surgery among patients with treatment-naive prostate cancer in the U.S. The study evaluation included nearly 25,000 patients, and the timeframe, 2007 to 2014, was chosen to avoid confounding factors related to the COVID-19 pandemic.
About Intuitive
Intuitive (NASDAQ:ISRG), headquartered in Sunnyvale, California, is a global leader in minimally invasive care and the pioneer of robotic surgery. Our technologies include the da Vinci surgical system and the Ion endoluminal system. By uniting advanced systems, progressive learning, and value-enhancing services, we help physicians and their teams optimize care delivery to support the best outcomes possible. At Intuitive, we envision a future of care that is less invasive and profoundly better, where disease is identified early and treated quickly, so that patients can get back to what matters most.
About da Vinci Surgical Systems
There are several models of the da Vinci Surgical System. The da Vinci surgical systems are designed to help surgeons perform minimally invasive surgery and offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels, and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.
For more information, please visit the company’s website at www.intuitive.com.
Important Safety Information
For important safety information, indications for use, risks, full cautions and warnings, please refer to www.intuitive.com/safety.
Contact Information
Peper Long, Intuitive
202-997-7373
peper.long@intusurg.com
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