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| GenCut core biopsy system--Courtesy of Medtronic |
Medtronic ($MDT) just launched the GenCut Core Biopsy system to collect lung cancer tissue from lesions deep inside the organ. The company says its blade design allows the device to collect larger and more intact samples, allowing enhanced pathology and cytology (microscopic imaging of cancerous cells), and ultimately improvements in personalized medicine of lung cancer.
"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, the president of Medtronic's early technologies business within the minimally invasive therapies group.
GenCut received the FDA's 510(k) clearance in April. "The core biopsy tool is comprised of a polymeric shaft with steel braid reinforcement and a stainless steel side-cutting tip. The extension tube connects to the proximal end of the core biopsy tool shaft via a connection hub. The extension tube fittings allow the user to provide suction to the shaft via the supplied syringe. Upon completion of sampling, the tissue removal brush can be inserted through the length of the shaft to collect any remaining tissue not expelled through aspiration," the FDA explained in its approval letter.
The tool marks Medtronic's increased focus on minimally invasive interventional surgery, as opposed to implants, thanks to the recent $50 billion acquisition of Covidien. GenCut will be navigated using Covidien's superDimension navigation system.
SuperDimension creates electronic images of patients' lungs using so-called LungGPS hardware and software so that physicians can guide a bronchoscope through the correct passages in the organ toward the tumor. Then a catheter is extended from the bronchoscope to the site of the tumor, and tools at the tip of the catheter, like GenCut, are deployed to collect biopsy samples.
Prior to the Medtronic merger, Covidien Chief Medical Officer Dr. Michael Tarnoff told FierceMedicalDevices that the company is aiming to expand the indication of superDimension over the next couple of years to include not just diagnosis but treatment of lung cancer. He said the company hopes to accomplish this via the FDA-CMS parallel review pilot program, which would result in faster Medicare reimbursement and is a sign that the company sees the improved product as especially promising.
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| SuperDimension--Screenshot courtesy of Covidien |
During the buildup to the merger, Medtronic officials consistently singled out superDimension as one Covidien's most promising devices. "They (Covidien) have this unique lung biopsy diagnostic and reception business which is new. And applying our market development capabilities to those type of assets is a very exciting opportunity," said Medtronic Senior Vice President Geoff Martha in October.
With the advent of personalized lung cancer drugs that require the collection of information from biomarkers like tumors for patient selection, the device figures to play a growing role in the treatment paradigm.
Medtronic said lung cancer kills more people than breast, colon and prostate cancer combined. And 85% of patients are diagnosed at a late stage, decreasing their chance of survival.
- read the release
- here's the 510(k) letter