PRECIsE Clinical Study Preliminary Results Favorable for Intuitive's Ion Endoluminal System for Peripheral Nodule Lung Biopsy.

ENPNewswire-October 19, 2021--PRECIsE Clinical Study Preliminary Results Favorable for Intuitive's Ion Endoluminal System for Peripheral Nodule Lung Biopsy

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Release date- 18102021 - SUNNYVALE, Calif. - Intuitive (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, 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...

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