MINNEAPOLIS, April 4, 2011 /PRNewswire/ — superDimension,
Ltd. ®, a privately-owned company that develops minimally
invasive interventional pulmonology devices, today announced it has
received FDA 510(k) clearance for the superDimension marker
delivery kit. The kit is designed for use with the Company’s
Electromagnetic Navigational Bronchoscopy (ENB) system, which has
treated a total of 20,000 total patients since commercial
launch.
David S. Wilson, MD, Columbus Regional Hospital, said, “This kit
will enable both pulmonologists and surgeons to place
radiosurgical markers deep in the lungs, facilitating the treatment
of early stage lung cancer through external beam radiation and
minimally invasive video assisted surgeries. This is an
exciting time in the diagnosis and treatment of early stage lung
cancer. The preliminary results of the National Lung
Screening Trial (NLST), combined with the ability that
superDimension gives us to access the deep lungs, has changed the
game for diagnosis and treatment of early stage lung cancer.”
ENB is a minimally invasive procedure, where a catheter is
inserted through the throat and uses Global Positioning System
(GPS)-like technology to biopsy lung lesions and lymph nodes all in
one outpatient procedure. ENB provides a three-dimensional virtual
“roadmap” of the lungs that enables a physician to maneuver
catheters through multiple branches of the bronchial tree,
extending beyond the capabilities of the traditional bronchoscope
to distant, previously inaccessible regions of the lungs. If
the targeted lesions are determined to be cancerous, the physician
can use ENB to place radiosurgical markers in and around lung
tumors (lesions) to help radiation oncologists treat patients with
external beam radiation. These radiosurgical markers can also be
enhanced with dye injected markers that facilitate a minimally
invasive surgical procedure. The outpatient procedure
typical
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