An Unmet Clinical Need

As the incidence of lung disease grows in the United States, the challenge of early and accurate diagnosis and treatment of lung lesions is becoming more critical. There is an urgent need for a reliable, minimally invasive tool for accessing lung lesions, especially those located beyond the reach of traditional bronchoscopes.

Peripheral lung lesions are beyond the reach of conventional bronchoscopes.

Although 1 in 500 chest x-rays show a peripheral lesion¹, 65% of traditional bronchoscopes fail to reach these distant lesions². More invasive diagnostic techniques are then necessary, posing a greater potential for complications such as pneumothorax³. Patients with poor lung function may not tolerate more invasive procedures, leaving them with "watchful waiting" as their only option.

Yet, early diagnosis and treatment are crucial for improving survival rates in malignant lung disease. A study determined that lung lesions diagnosed early (Stage I) resulted in a survival rate of 88% at 10 years⁴. Compare this to lung cancer patients diagnosed at Stage III or IV where survival rates typically are 15% at 5 years⁵.

The superDimension i·Logic System addresses this unmet medical need by enabling physicians to access peripheral lung lesions and mediastinal lymph nodes with a minimally invasive technique suitable even for patients who cannot undergo more invasive procedures. With the i·Logic System, physicians gain access to distal lesions in a minimally invasive manner.

i·Logic Solution

i·Logic addresses an unmet critical need to provide access to distal lung lesions through Electromagnetic Navigation Bronchoscopy® (ENB)™. Using a patient’s CT scan, a virtual 3D bronchial tree extends deep into the lungs for enhanced visualization to the lesion. Automatic Registration and Airway Sync continuously updates navigation of the Locatable Guide tip position to the target position. Once at the target, the LG is removed and the guide catheter provides a channel for diagnostic treatment or therapeutic tools.

Multiple Applications

The i·Logic System enables physicians to navigate deep into the lungs, offering a breadth of customized treatment options for patients. Using Electromagnetic Navigation Bronchoscopy® (ENB)™, Pulmonologists and Thoracic Surgeons can access peripheral lung lesions through a minimally invasive pathway.

Navigate to Peripheral Lung Lesions and Biopsy for Diagnosis

• ENB uses steerable catheters and electromagnetic technology to provide simultaneous guidance and access to peripheral lesions in the lung for diagnosis
• i·Logic combines accuracy, intuitive functionality and confidence to diagnose peripheral lung lesions, enhancing efficiency and potentially improving patient outcomes
• i·Logic provides safe, efficient access to lung lesions in virtually all non-operable patients and carries a low pneumothorax rate, similar to that of standard bronchoscopy

Stage Lymph Nodes for Diagnosis and Pre-Operative Planning

• i·Logic provides real-time localization of lymph nodes making biopsies more accurate than blind TBNA
• ENB offers high success rates in reaching subcarinal and mediastinal lymph nodes

Place Radiosurgical Markers for Radiation Treatment

• ENB allows pinpoint RSM placement in and around lung tumors to guide external beam radiation
• Small solitary lung tumors can be accurately treated, preserving surrounding healthy lung tissue
• i·Logic placement of markers enables physicians to carefully track changes in tumor position during treatment position during radiation therapy and tumor morphology over time.

Place Makers to Facilitate Pulmonary VATS

• i·Logic offers physicians clear access to mark locations in peripheral lung lesions and near the pleura surface
• ENB through marker placement generates accurate guidance during Video Assisted Thorascopic Surgery (VATS)
• Lung nodules that may not be visible or palpable at time of surgery can be identified through non-invasive i·Logic marker placement

Guide Brachytherapy

• The i·Logic System is well suited for the delivery of radiation sources to the desired treatment site
• Effective HDR and LDR tumor treatment can be delivered to a broader range of patients