Intuitive Announces FDA Clearance of Revised da Vinci Xi and X Labeling on Radical Prostatectomy
05 6월 2024 - 9:30PM
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 IntuitiveIntuitive (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 SystemsThere 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 InformationFor important
safety information, indications for use, risks, full cautions and
warnings, please refer to www.intuitive.com/safety.
Contact InformationPeper Long,
Intuitive202-997-7373peper.long@intusurg.com
Intuitive Surgical (NASDAQ:ISRG)
과거 데이터 주식 차트
부터 8월(8) 2024 으로 9월(9) 2024
Intuitive Surgical (NASDAQ:ISRG)
과거 데이터 주식 차트
부터 9월(9) 2023 으로 9월(9) 2024