FDA grants 510(k) clearance for superDimension's marker delivery kit

Apr 4 2011

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 typically leaves the patient with no more than a sore throat.  ENB has been performed on over 20,000 patients in over 320 hospitals worldwide.

Previously, the "gold standard" to diagnose lung cancer consisted of two invasive surgeries:  wedge thoracotomy (open chest partial lung removal) to biopsy the lung and mediastinoscopy (invasive lymph node surgery) to biopsy the lymph nodes.  Patients with poor lung function who could not tolerate these more invasive procedures were left with "watchful waiting" as their only option.