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#MEDTRONIC EINSTEIN PLATFORM GENERATOR#

Enrollment of 30 subjects in the NAVABLATE ablation safety study in Europe and Hong Kong was completed in September 2020.It can be used together with standard of care therapy when indicated.

#MEDTRONIC EINSTEIN PLATFORM GENERATOR#

The Emprint™ ablation catheter kit is an unapproved device in the United States and is intended to be used in conjunction with the Emprint™ microwave generator and Medtronic navigation platform to provide a minimally invasive, localized treatment of malignant lesions in the lung.The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Food and Drug Administration (FDA) for the Emprint™ ablation catheter kit in April 2021. Medtronic received Breakthrough Device Designation status from the U.S.Allows expanded access for physicians to reach lesions that do not have airway entry points through utilizing state of the art innovative tools such as the Medtronic CrossCountry™ transbronchial access tool - helping doctors to reach the ~50% of nodules that are outside the airway.Enables doctors to sample tissue in multiple areas of nodules - helping to obtain adequate tissue collection from all over the nodule to aid in optimal tissue specimens.Enhances visibility of suspicious tissue in the lungs.

Provides a minimally invasive option for biopsy and treatment where the technology is legally marketed.

The ILLUMISITE™ platform is available in the United States, Europe, Hong Kong, Canada, and Taiwan and offers four distinct benefits:

Minimally invasive approaches - compared to open procedures - are proven to result in shorter hospital stays, less pain, and faster return to normal activities 4.

When caught early and treated, lung cancer survival soars to 92% 3,§.

74% of lung cancer patients are diagnosed at late stages 2, offering a survival rate of just 19% 1, ‡.

Each year, more people die of lung cancer than from colon, breast, and prostate cancers combined 1.

By combining the power of our ILLUMISITE™ platform and endoluminal ablation technology, we’ve introduced innovation that can aid in the diagnosis and treatment of lung masses not someday, but this day,” said Emily Elswick, Vice President and General Manager, Lung Health and Visualization, Medtronic. “This is a significant milestone in our commitment to unlock comprehensive solutions that enable clinicians to identify, diagnose, and treat lung masses sooner. Once there, the physician used the specialized Emprint™ ablation catheter kit † to deliver a minimally invasive, localized treatment to the lesion in the lung. The virtual pathway and navigation catheter enabled physicians to navigate through the patient’s airways. Then, in the procedure, the physicians inserted a bronchoscope along with a navigation catheter into the patient’s mouth. Using a patient’s CT scan, the ILLUMISITE™ platform allowed the physicians to create a customized virtual pathway through the patient’s lungs, much like a GPS map commonly used to drive to a destination.

Rainbow Lau from Hong Kong for a patient with a lung lesion. The minimally invasive procedure was completed by Professor Calvin Ng and Dr. Medtronic announced today the first-in-world endoluminal lung ablation using the ILLUMISITE™ platform. A minimally invasive approach, the ILLUMISITE™ platform navigates accurately to even the most distant areas of the lung, and can sample multi-directionally for a thorough biopsy.