The U.S. Food and Drug Administration today allowed marketing of the Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by biopsies performed to confirm a diagnosis of suspected lung conditions.
The system reduces the risk of a patient experiencing a collapsed lung during a percutaneous transthoracic needle lung biopsy (a biopsy performed through the chest wall). A collapsed lung occurs when air from the lung leaks into the space around it, preventing the lungs from expanding properly. The condition can cause chest pain, shortness of breath, and cardiovascular distress and is particularly dangerous in patients who have lung disease.
"This is an innovative new use for an existing device that can help make percutaneous transthoracic needle lung biopsies safer," said Christy Foreman, director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health.
The Bio-Seal system is composed of a syringe, pre-filled with a hydrogel that has been solidified and then dried, attached to a slender wire (stylet). After the biopsy sample is removed, the physician attaches the system to the needle used to access the biopsy site and injects the hydrogel through the stylet into the empty space left by the removed lung tissue. The dried hydrogel rehydrates and expands on contact with body fluids to fill the space, creating a seal that prevents air from leaking out of the lung. The hydrogel is absorbed into the body after healing of the puncture site has occurred.
The FDA reviewed data to expand the indication of the Bio-Seal system through the de novo classification process, a regulatory pathway for some low-to-moderate risk medical devices that are not comparable to a legally marketed device.
The FDA granted the de novo petition based on a randomized clinical trial of 339 patients undergoing percutaneous transthoracic needle aspiration biopsy for noncalcified lung masses (growths on the lung). The trial showed that the group of patients treated with the hydrogel post-biopsy experienced a significantly lower number of collapsed lungs in the 30 days following the biopsy than the group of patients who received standard post-biopsy treatment.
Adverse events associated with the system were consistent with risks associated with percutaneous transthoracic fine needle aspiration biopsy, and included collapsed lungs and minor and major bleeding.
The system was first cleared by the FDA in 2004 as the Lung Biopsy Site Marker with an indication for marking the site where a lung biopsy was taken. The hydrogel is visible on medical imaging devices, so if biopsy results indicate the need for surgery or other treatment, the physician could accurately locate the affected area.
The Bio-Seal Lung Biopsy Tract Plug System is manufactured by Vancouver, British Columbia-based Angiotech.