Medtronic Launches GenCut Core Biopsy System

Medtronic plc has rolled out the GenCut core biopsy system, a unique lung tissue biopsy tool for use with the SuperDimension navigation system. The SuperDimension system enables a minimally invasive approach to accessing difficult-to-reach areas of the lung, which can aid in the diagnosis of lung cancer.

The GenCut core biopsy system is a unique tool that allows pulmonologists and thoracic surgeons to collect multiple core samples from lesions deep inside the lungs. With its proprietary blade design, the GenCut core biopsy system can shear and collect larger, more intact samples, and allows physicians to provide the pathology laboratory with tissue that enables cytology, which is the microscopic appearance of cells, histology and molecular profiling for personalized medicine, according to the company. With the ability to continuously sample, in one pass, physicians can potentially decrease patients’ biopsy procedure times.

“Lung cancer diagnostic clinicians consistently state that tissue is the issue. When performing a biopsy, they need enough tissue for the pathologist to make a diagnosis and to ensure undamaged tissue for genetic testing and molecular analysis. As lung cancer drugs and therapies advance, the ability to provide earlier diagnosis and earlier, personalized treatment can potentially save lives,” said Chuck Brynelsen, president, Early Technologies business in Medtronic’s Minimally Invasive Therapies Group. 

According to the American Lung Association, lung cancer is the leading cause of cancer-related deaths in the United States. In its early stages, lung cancer presents few, if any, symptoms. As a result, the vast majority of lung cancer patients are diagnosed in the late stages, when there is minimal chance for long-term survival.

Brynelsen added: “The continuum of care is the healthcare journey a patient takes from diagnosis to recovery. Our goal, across this continuum, is to diagnose earlier, intervene earlier, treat better and help patients recover faster.”

The GenCut core biopsy system received U.S. Food and Drug Administration 510(k) clearance in April.

The lung cancer five-year survival rate is 17.8 percent–much lower than the survival rate of other primary forms of cancer, such as colon (65.4 percent), breast (90.5 percent) and prostate (99.6 percent) cancer.  For those detected with late-stage lung cancer, their five year survival rate is only 4 percent.

Currently, the global biopsy devices market is expected to grow at a compound annual growth rate of 6.3 percent from 2013 to 2018. Naturally, innovation of biopsy tools capable of detecting lung cancer at an early stage makes for a high-interest area among healthcare providers such as Medtronic.