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Cook Medical announced the launch of its EchoTip ProCore Endobronchial Needle, an endoscopic device that will help physicians and pathologists diagnose lung cancer earlier. It’s the first endobronchial ultrasound needle in the U.S. that can collect histological samples. With it, physicians can retrieve cell and tissue samples from the lymph nodes or tumors in the pulmonary area through a minimally invasive procedure.
The current gold standard in lung cancer diagnostics is mediastinoscopy, a surgical procedure that allows the doctor to fully visualize the area and remove what’s targeted for biopsy, Cook product manager Kevin Chmura said. A physician could remove a whole lymph node if need be. This has nearly a 90 percent success rate as a diagnostic. The other common procedure, a bronchoscopy has physicians stick an endoscope right into the nose or mouth. But because of visualization issues, it’s a blind procedure and it only has a 36 percent success rate, he said.
With the EchoTip ProCore, physicians use ultrasound imaging to view the lesion from which tissue is collected. A single-use needle is inserted through an echoendoscope to biopsy lesions “within or adjacent to the tracheobronchial tree or gastrointestinal tract,” according to a company statement.
“You’re doing less needle sticks and getting more information to help that patient out at the end of the day,” Chmura said, adding the patient wouldn’t need to come back for stressful try after try for diagnosis. A new, more flexible 25-gage needle helps docs deflect the endoscope more and potentially reach more pulmonary target lesions. In fact, because the samples are so large — thousands of cells, Chmura said it’s easier for pathologists in the lab to perform different tests and stains.
“You can actually see that piece of tissue. That’s affirmation and a warm and fuzzy feeling for that pathologist.” Aside from cutting cost from care — no surgery, in theory fewer visits for diagnosis and potentially earlier diagnosis — it could also lead to more personalized treatment.
“Because we’re able to offer more yield in our passes, we hope to see the treatments for the patient become more tailored,” Chmura said. According to the Centers for Disease Control and Prevention, lung cancer is the leading cause of cancer death in the United States and the second most common form of cancer. In 2010, more than 200,000 Americans were diagnosed with the disease and more than 150,000 died of it.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The technology also can be used to diagnose other mediastinal diseases.
The device is a platform technology Cook first launched in the gastrointestinal space. Chmura said that after talking to physicians it became clear the pulmonary space, with similar visualization issues, could benefit from collecting larger tissue samples with a like procedure.
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