Covidien bought Minneapolis-based superDimension in 2012 when the startup already had its lung navigation system cleared by regulatory bodies in Europe and U.S. for several years.
The Massachusetts device maker hasn't been able to sell too many of these devices despite clearing regulatory hurdles - in fact, Michael Minnette, Vice President, Covidien's Interventional Lung Solutions said, in a recent interview that globally about 550 devices have been sold that were used in 50,000 procedures.
But the $193,000 device may be getting past the early-adopter phase. Covidien is hoping to get a boost from a draft recommendation by the U.S. Preventive Services Task Force to primary care providers, and really push its pulmonary device to physicians. In September, Minnestte and a physician-consultant, Dr. Sandeep Khandhar, thoracic surgeon at Cardiac Vascular & Thoracic Surgery Associates in Virginia, were demonstrating the iLogic system at the annual AdvaMed conference in Washington, D.C.
The Task Force's draft recommendation states that patients at high risk for lung cancer should be annually screened using low-dose CT scans. Although the recommendation isn't final, it was an important acknowledgment of the effectiveness of screening for lung cancer, a formidable killer.
"Lung cancer is the leading cause of cancer death in the United States and a devastating diagnosis for more than 200,000 people each year,” said Task Force chair Virginia Moyer, M.D., M.P.H. in a news release. “Sadly, nearly 90 percent of people who develop lung cancer die from the disease, in part because it often is not found until it is at an advanced stage. By screening those at high risk, we can find lung cancer at earlier stages when it is more likely to be treatable.”
The recommendation comes after a publication in the New England Journal of Medicine in 2011, that showed that CT screening was much for effective in detecting lung cancer than X-Ray, explained Khandhar, in a recent phone interview.
"The study showed that chest X-Ray is essentially a worthless modality," said Khandhar. "What it also said, using CT screening in high-risk patient populations actually improves overall survivial and improves mortality."
Having used superDimension's iLogic system, Khandhar is convinced that it will beneifit luncg cancer screening programs around the country by minimizing complications related to CT-guided needle biopsy and invasive surgery.
That's because the iLogic system allows a much better access to the the area of interest within the lung compared with conventional methods of minimally-invasive lung cancer screening - bronchoscpiocally and perculatenously using CT-guided needle biopsy.
The system also prevents unnecessary invasive procedures like surgery on patients who are already sick. Khandhar recalled the case of an elderly female patient with compromised lung function. The radiologist did not want to do a needle biopsy for fear of lung collapse. A traditional, blind bronchoscopy had not yielded any results and the only other option to detect what was going on in her lungs was invasive surgery but physicians were reluctant to do that because she would need to be on oxygen during the procedure.
"So we decided to use superDimension's device and we were able to get a very accurate biopsy and prove in the lab that lo and behold this was not cancer at all, but a lung infection," Khandhar said.
She was put on a treatment and soon enough the "tumor" disappeared. Khandhar said that the iLogic system is not the "be all and end all" of lung cancer detection but was better than competing navigational devices. It's ease of use made it useful to detect cancer early even in not-so-skilled hands.
"This technology is a tool that adds a considerable amount of diagnostic certainty to traditional bronchoscopy making it having the same if not higher diagnostic yield as percutaneous biopsy with fewer complications," he said. "That's why it's a game changer."
[Photo Credit: iStockphoto.com user dem10 ]