The US Food and Drug Administration (FDA) has approved Angiotech Pharmaceuticals’ proprietary biopsy device system, designed to prevent air leaks that can lead to a collapsed lung or pneumothorax, in patients undergoing lung biopsies.
The Bio-Seal Lung Biopsy Tract Plug system with proprietary hydrogel plug, when in contact with moist tissue, absorbs fluids and expands to fill the void created by the biopsy needle puncture.
After healing of the puncture site, the plug gets absorbed into the body, according to the company.
The approval was based on a multicentred, prospective, randomised clinical study, designed to evaluate the safety and efficacy of the biopsy device system.
Reduced rates of pneumothorax in patients undergoing lung biopsy procedures was the primary endpoint for the study.
Results demonstrated that the trial achieved its primary end point, with clinical success in 85% of patients treated with Bio-Seal, compared to 69% for the control patients (p=0.002), representing a 50% reduction in the risk of pneumothorax in the Bio-Seal patient group.
Angiotech Pharmaceuticals president and CEO Thomas Bailey said the device has also been shown to significantly reduce complication rates in patients receiving lung biopsy procedures.
"Bio-Seal represents a significant and proprietary addition to our broad portfolio of products for the diagnosis of cancer," Bailey added.
Bio-Seal system, which is expected to be sold under the brand name BioSentry, will be made available in the US in the first quarter of 2013.