Angiotech Pharmaceuticals has gained US marketing rights for its Bio-Seal Lung Biopsy Tract Plug system, following the approval from the US Food and Drug Administration (FDA).
Featuring a proprietary hydrogel plug, the proprietary biopsy device system is designed to prevent air leaks that lead to a collapsed lung or pneumothorax in patients undergoing lung biopsies.
The hydrogel plug, when comes in contact with moist tissue, absorbs fluids and expands to fill the void created by the biopsy needle puncture as well as gets absorbed into the body after healing of the puncture site, claims the company.
The approval was based on a multi-centered, prospective, randomized trial, designed to study the safety and efficacy of biopsy device system.
Results demonstrated that the trial achieved its primary end point, with clinical success in 85% of patients treated with Bio-Seal, as 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 shown to significantly reduce complication rates in patients receiving a lung biopsy procedure.
"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.