Results Demonstrate Feasibility of Bronchoscopic Microwave
Ablation for Certain Patients with Malignant Lung Nodules
DUBLIN, Sept. 7, 2021 /CNW/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced new clinical data from the NAVABLATE study, which
highlights the much anticipated safety and performance results on
microwave ablation used bronchoscopically with the Emprint™
Ablation Catheter Kit with Thermosphere™ Technology in conjunction
with the Medtronic electromagnetic navigation bronchoscopy system.
Results were reported as a late-breaking presentation at the
virtual European Respiratory Society International Congress 2021,
September 5, 2021.
"Patients with malignant lesions in the lung often have limited
therapy options due to lesion locations, comorbidities, and
treatment side effects," said Kelvin
Lau, M.A., DPhil, FRCS(CTh), a consultant thoracic surgeon
at St. Bartholomew's Hospital, London, and a principal investigator for the
NAVABLATE study. "The results from the NAVABLATE study explore the
potential benefit of a more individualized treatment for patients
and offer a new option for surgeons and physicians to provide a
minimally invasive, localized treatment of malignant lesions in the
lung."
NAVABLATE is a prospective, multi-center study that enrolled 30
subjects in the United Kingdom and
Hong Kong to characterize the
safety and performance of the CE Marked Emprint Ablation Catheter
Kit. All patients underwent a bronchoscopic ablation procedure
using the Emprint Ablation Catheter Kit and were followed for one
month post procedure.
"Despite advances in treatment that can extend survival, the
challenges of long-term management of tumors in the lung have been
a significant barrier to improving outcomes, quality of life, and
extended time with loved ones," said Emily
Elswick, vice president and general manager, Lung Health
& Visualization, within the Surgical Innovations business,
which is part of the Medical Surgical Portfolio at Medtronic.
"Medtronic continues to take a broad transformative approach to the
care continuum for the treatment of lung disease to improve
diagnostics, optimize therapy and accelerate recovery."
Results of the NAVABLATE study demonstrated bronchoscopic
microwave ablation is an option for primary and oligometastatic
malignant lung nodules £30mm in patients who decline or are not
candidates for both surgery and stereotactic body radiation therapy
(SBRT). Ablation using the Emprint Ablation Catheter Kit achieved
100% technical success (nodule reached and ablated in accordance
with the study protocol) in all 30 subjects immediately
post-procedure. One-month imaging showed satisfactory ablation of
the nodule in 100% of subjects. The composite rate of adverse
events related to the Emprint Ablation Catheter Kit was 3.3% (one
subject with mild hemoptysis). There were no deaths or
pneumothoraces.
The Emprint Ablation Catheter Kit is in development and recently
received Breakthrough Device Designation status from the U.S. Food
and Drug Administration (FDA) in April
2021. This device is not approved or cleared by FDA and is
not available for sale in the U.S. The catheter is intended to be
used in conjunction with the Emprint™ microwave generator and
Medtronic electromagnetic navigation bronchoscopy system to provide
a highly localized treatment of malignant lesions in the lung, and
it can be used together with standard of care therapy when
indicated. Medtronic will continue to study the safety and efficacy
of the Emprint ablation catheter kit under an upcoming FDA
investigational device exemption (IDE) study, with the intent to
submit for device approval or clearance at a future date.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services, and
solutions companies – alleviating pain, restoring health, and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals, and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
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SOURCE Medtronic plc