Intuitive (Nasdaq: ISRG), a global technology leader in minimally
invasive care and the pioneer of robotic-assisted surgery, today
announced the release of preliminary data from 69 subjects
participating in the Prospective, Multi-Center Evaluation of the
Clinical Utility (PRECIsE) – a post-market, multi-center clinical
trial of its Ion endoluminal system.
Use of the Ion system for pulmonary nodule biopsy resulted in an
83% diagnostic yield, which represents the likelihood that tissue
samples obtained during the procedure will provide physicians with
information needed to establish a diagnosis. PRECIsE is the first
multi-center study of the Ion system’s shape-sensing,
robotic-assisted technology. Among the initial results of the
ongoing study reported Sunday at the American College of Chest
Physicians (CHEST) conference, the Ion system showed:
- Encouraging diagnostic yield for
both smaller and larger nodules: Ion-enabled biopsies helped
investigators obtain a diagnosis in 82% of cases with nodules
between 1-2 centimeters, 85% with nodules between 2-3 cm. The
similarity between yield rates for both smaller and larger nodules
biopsied with Ion is a favorable result for clinicians seeking to
sample smaller nodules.
- A strong safety profile: the Ion
system had no serious adverse events reported in this subset of
patients in the study, and no pneumothorax events requiring a chest
tube.
- Sensitivity for malignancy from
samples obtained from nodule biopsy was 84%-88%. Sensitivity is an
indicator of the number of malignant conditions found from the
tissue samples obtained.
“This study is another step to help confirm what we’ve seen and
heard from physicians using Ion—that our technology helps them
safely gain access to the appropriate portions of the lung to
biopsy small nodules,” said Intuitive CEO Gary Guthart. “The Ion
system’s progress further demonstrates how minimally invasive
technologies can help create better outcomes for patients,
surgeons, and care teams.”
These preliminary results of 69 subjects with up to 14-month
follow up for applicable subjects are a subset of the study’s total
of 365 patients, who were enrolled across six medical centers
beginning in March 2019. The Ion system was used by investigators
to sample nodules 10-30mm in diameter with Ion’s flexible
articulating catheter that, combined with PlanPoint mapping
software, enables the users to access the peripheral portions of
the lungs, where many nodules are typically found.
“We’ve been waiting to see if the multi-center clinical evidence
shows that shape-sensing robotic-assisted bronchoscopy can provide
answers earlier in lung cancer,” said Dr. David Ost of The
University of Texas MD Anderson Cancer Center in Houston, the
study’s presenting author. “These are encouraging results on the
potential for this technology to help safely biopsy small lung
nodules.”
During a procedure using the Ion system, a physician will insert
the Ion fully articulating catheter into the patient’s lung via the
mouth and throat through an endotracheal tube, which may have fewer
complications than biopsy approaches that use a needle inserted
from outside the body.
The Ion system’s ability to navigate to small nodules and
enable biopsies may help physicians get answers for patients,
potentially enabling more time to consider medical management
options. There are currently more than 70 Ion systems installed in
U.S. hospitals as of the second quarter of 2021, and Intuitive
continues to explore its applications in other countries.
About Intuitive
Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale,
California, is a global technology leader in minimally invasive
care and the pioneer of robotic-assisted surgery. As part of our
mission, we believe that minimally invasive care is life-enhancing
care. Through ingenuity and intelligent technology, we expand the
potential of physicians to heal without constraints.
Intuitive brings more than two decades of leadership in
robotic-assisted surgical technology and solutions to its offerings
and develops, manufactures, and markets the da Vinci Surgical
System and the Ion endoluminal system.
Da Vinci® and IonTM are trademarks or registered
trademarks of Intuitive Surgical, Inc.
For more information, please visit the Company’s website
at www.intuitive.com.
About the da Vinci Surgical System
There are several models of the da Vinci Surgical
System. The da Vinci surgical systems are designed
to help surgeons perform minimally invasive surgery.
Da Vinci systems 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.
About Ion
Ion is Intuitive’s robotic-assisted platform for minimally
invasive biopsy in the lung. The system features an ultra-thin,
ultra-maneuverable catheter that allows navigation far into the
peripheral lung and provides the unprecedented stability necessary
for precision in biopsy. Visit
www.intuitive.com/en-us/products-and-services/ion
Important Safety Information
Risk associated with bronchoscopy through an endotracheal tube
and under general anesthesia are infrequent and typically minor,
and may include but are not limited to: sore throat, hoarseness,
respiratory complications including dyspnea or hypoxemia, airway
injury, bronchospasm, laryngospasm, fever, hemoptysis, chest or
lung infection including pneumonia, lung abscess or an adverse
reaction to anesthesia.
Although rare, the following complications may also occur:
bleeding, pneumothorax (collapsed lung), cardiac related
complications, respiratory failure, air embolism, or death.
As with other medical procedures, there may be additional risks
associated with the use of general anesthesia and/or endotracheal
intubation which are not listed above; you should consult a health
care professional regarding these and other potential risks.
Procedures using the Ion Endoluminal System may be associated
with longer procedure and/or longer anesthesia time.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the performance of the Ion
Endoluminal System. These statements reflect the best judgment of
the Company's 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, including
the risk that our products may not achieve market acceptance. These
forward-looking statements should, therefore, be considered in
light of the risk factors under the heading “Risk Factors” in our
report on Form 10-K for the year ended December 31, 2020, as
updated by the Company’s other filings with the Securities and
Exchange Commission. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date of this press release. The Company undertakes no obligation to
publicly update or release any revisions to these forward-looking
statements, except as required by law. For more information, please
visit the company’s website at www.intuitive.com.
ContactGlobal Public AffairsIntuitive
Surgicalcorp.comm@intusurg.com+1-408-523-7337
Source: Intuitive Surgical, Inc.
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