Treatment for diseases of the lungs, particularly cancer, is undergoing a technology shift that's analogous to the early days of angioplasty: Electromagnetic navigation bronchoscopy (ENB) is helping physicians to reach lesions deep in branches of the lungs in a minimally invasive fashion. It helps patients avoid diagnostic surgeries and early death.

superDimension (Minneapolis) has just launched the iLogic System, which allows an interventionalist to more safely access lesions via a bronchoscope down the throat, rather than through open chest surgery (thoracotomy) or even needle aspiration, procedures that both carry significant risks for the patients who are eligible. A much broader patient population is eligible for ENB than than other procedures.

"What's happening right now is that the medical community is discovering the superDimension procedure literally within the last year," Daniel Sullivan, president/CEO of superDimension, told Medical Device Daily. "For years the medical institutions looked at patients with spots on their lungs as almost lost in space because their only option was a very invasive biopsy. Millions of patients went on watchful waiting."

For those whose lesions were cancerous, watchful waiting meant waiting for death.

Since lung cancer is the leading cause of cancer death for both men and women, diagnosing and treating it at earlier stages is paramount to putting the brakes on a disease that kills more people than colon, breast and prostate cancers combined.

In sync with this new product launched, the American Medical Association (AMA; Chicago) has just issued a new Category I CPT code for the use of superDimension's ENB device to navigate to lesions or spots deep in the lungs. The code will become effective Jan. 1. The AMA also issued a new CPT I code for the placement of fiducial radiosurgical markers via the ENB procedure.

ENB is performed on an outpatient basis and starts with a catheter inserted through the throat or nose. If the targeted lesions are determined to be cancerous, a pulmonologist can use ENB to transbronchially place radiosurgical markers in and around the lesions to help radiation oncologists treat patients with external beam radiation. The procedure typically leaves the patient with no more than a sore throat.

Prior to ENB, the gold standard to diagnose lung cancer was one 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, or those with comorbidities, were left with watchful waiting as their only option.

superDimension appears to be the only player in this emerging field. The company launched a predecessor to iLogic two years ago called inReach (MDD, Sept. 10, 2007). iLogic improves on that design, offering a simplified positioning and navigational system that improves ease of use and further enhances visualization for the pulmonologist.

"The previous system had three screens and the doctor would watch those three and make an interpretation in his head on where the tip of the catheter was," Sullivan said. "Our new system no longer forces him to make that 3-D interpretation. It's on the screen now. They can see blood vessels, lungs, airways. It gives them all the information they could want in terms of visualizing a lung lesion."

superDimension debuted the iLogic system at the recent American College of Chest Physicians (CHEST; Northbrook, Illinois) annual meeting in San Diego and the American Society for Radiation Oncology (ASTRO; Fairfax, Virginia) Conference in Chicago this week.

The 3-D improvements in the iLogic system include a new software platform with a simplified positioning and navigational system. The virtual 3-D bronchial tree made possible with the technology extends deep into the lungs reaching more than 17 airway generations. Additionally, customized high-definition views available with iLogic offer physicians multiple navigation perspectives to improve detection and diagnosis. A 26-inch high-definition wide screen format allows six viewports to be displayed simultaneously, including one video input, enabling the physician to evaluate positional data and optimize central and peripheral guidance within the lung.

Surgeons generally needed 1.5 days of training on the inReach system, but with the new 3-D features, that training period is reduced for iLogic.

"As medical professionals become more comfortable and familiar with ENB, we believe the introduction of iLogic will further ignite enthusiasm for adoption of the system and ultimately, improve patient outcomes," Sullivan said.

ENB has FDA 510(k) clearance in the U.S., CE mark in Europe and it has also been approved for use in Australia and Canada. Sullivan said that more than 9,000 patients have undergone ENB and 200 systems are in use worldwide with 150 in the U.S.

iLogic is priced at $153,000 and catheter systems are $1,000 for each patient.

Sullivan said it took three years to obtain the CPT code and he now expects private insurers to follow suit as the company's flagship product is used at more hospitals.

superDimension, he said, is sufficiently funded at present, but "No small, private company ever has enough funding. We're in pretty good shape with a strong group of venture capital investors and some very large institutional investors. We're are contemplating another funding round in 4Q of this year."

Moving forward, he envisions the application of iLogic to other lung diseases, such as asthma, chronic obstructive pulmonary disease and interstitial disease.

"Our current focus is lung cancer because it's the largest cancer killer," he said. "Long term survival is just 15%. Our opportunity is to be able to diagnose and facilitate treatment in the earliest stages when you still have an opportunity to dramatically increase survival rates."