A Medical Device Daily

Not often do you hear lung airways referred to in the same breath with the term “road maps,” but that’s exactly what you get with the description of a new technology from superDimension (Minneapolis), called the inReach System. inReach offers physicians in search of small lesions in the lungs for biopsy — lesions that until now have mostly required patients to remain in a passive posture of “watchful waiting.”

The new imaging tool is the first to allow physicians access to smaller, harder-to-reach lung lesions, according to the company. To do that it uses electromagnetic navigation and guidance similar to the increasingly popular global positioning systems (GPS) which provide e-roadmaps for automobile travel.

“This has the potential to do for pulmonologists what angioplasty did for cardiologists, and it’s part of why I joined the company,” Dan Sullivan, CEO of superDimension, told Medical Device Daily. “It is a game-changing platform technology. I think it’s going to save a lot of lives.”

Sullivan’s past expertise and involvement in growing successful companies suggest he knows of what he speaks.

On its web site, superDimension refers to him as one of the “key executives” responsible for the development of SCIMED Systems from start-up to when it was sold to Boston Scientific (Natick, Massachusetts) in 1995 for just over $1 billion.

According to Sullivan, that former business comprises now “most of Boston Scientific’s catheter business.”

Sullivan says that superDimension, founded in Israel, has developed “core technology” that he called – hardly attempting to understate his opinion — “magnificent.”

Sullivan acknowledged that “the commercialization effort from Israel to the U.S. wasn’t the best – there were a few growing pains” — initially. But the company has now reentered the U.S. market, expecting to get a boost from the recent clearance.

The inReach System, using a standard computed tomography (CT) scan image that is imported into its computer system, uses algorithms to take the scan and create a roadmap though the airways to any small lesion identified.

While very small lesions can be identified using CT, such scans are not used for final diagnosis of the lesion but rather to guide a biopsy procedure, Sullivan said. The scan provides a “beautiful map of the lungs or the airways, which are quite convoluted,” he said. Air “goes in your mouth and your nose in one tube, splits into two, four, eight, 32 and up to 150,000 [individual airways].”

In the procedure, the physician uses a catheter, “about the size of a small drinking straw.” A “small sensor” tracks the tip of the catheter using the CT image, directing the physician through the airways toward the lesion.

“The system gives you the map, and tells you which way to turn, and the doctor actually can articulate the catheter to follow the instruction on the television screen,” Sullivan said.

At that point, biopsy tools are used to take a sample of the lesion. And it is here that the system appears to offer hope for those with a positive biopsy: because the lesion is still small and has been identified earlier than traditional methods, such as bronchoscopy or transthoracic needle biopsies, the patient can begin treatment early.

Those with lung cancer — a disease claiming more than 1.3 million lives each year worldwide — can have a survival rate ranging up to 88%, if caught and treated early, Sullivan said. That compares to a 15% survival rate for those diagnosed at a late-stage, the unfortunate, more typical scenario.

The minimally-invasive system enables a patient to avoid bronchoscopy, needle aspiration or surgery, all of these categorized by Sullivan under the term “wedge procedure,” whereby the chest is opened “in a search for this lesion that’s the size of the tip of your finger.”

The option of transthoracic needle biopsy comes with a 30% to 50% chance of collapsed lung, since the needle actually is used to pierce the lung.

Finally, the course pursued by many if a lesion is detected via CT is that of “watchful waiting,” he said. “You come back to the hospital every year and get another CT scan and wait until the lesion grows big — then you get a conventional bronchoscopy, and the typical prognosis is a very short [time to] death.”

He added: “Lung cancer patients are sort of lost in space; nobody really knows what to do with them.” But he expects that to change.

At Cleveland Clinic — which was involved in studies of the inReach system and has brought the system into its standard protocols — Thomas Gildea, MD, said in a statement that “electromagnetic navigation bronchoscopy now increases the chances that a patient will safely get a diagnosis and begin treatment.”

Gildea, of the clinic’s Department of Pulmonary, Allergy and Critical Care Medicine, conducted one of the 13 published studies, one in the American Journal of Respiratory Critical Care Medicine, on the inReach System.

In a 2006 study that involved 60 patients, Gildea and a team of researchers concluded: “Electromagnetic navigation bronchoscopy is a safe method for sampling peripheral and mediastinal lesions with high diagnostic yield independent of lesion size and location.”

Study data reported a yield of 74% of peripheral lesions, 100% of lymph nodes, with 57% of the lesions being greater than 2 cm in diameter.

superDimension is now marketing the system in the U.S. and in Western Europe. The capital cost of the system is about $130,000 — a cost that should be “quickly justifiable for the hospitals,” Sullivan said — with disposables bringing the company $1,000 per procedure. Also, he said the company already has a “multi-million-dollar back order” for the systems.

Sullivan said that he doesn’t believe these costs will prevent hospitals or patients from using the system, since its ability to provide an earlier diagnostic will save huge dollars in terms of the long-term costs of care for dealing with a cancer.

And certain CMS codes are available for the system, though Sulllivan said that the company is pursing its own set of specific reimbursement codes for inReach use.

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