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Intuitive Announces Favorable Preliminary Results for ION in PRECIsE Clinical Study


Intuitive has 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.

Source: Intuitive Surgical, Inc.

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