Angiotech gets US nod to sell bio-seal lung biopsy tract plug system in U.S.
Angiotech Pharmaceuticals, Inc. ("Angiotech") announced today that it received approval from the U.S. Food and Drug Administration ("FDA") to market and sell its proprietary Bio-Seal Lung Biopsy Tract Plug System in the United States.
The device is the first of its kind approved by the FDA, and represents a significant advance in the safety of this important diagnostic procedure.
"Bio-Seal represents a significant and proprietary addition to our broad portfolio of products for the diagnosis of cancer," said Thomas Bailey, President and CEO of Angiotech. " Mr. Bailey also said, "This device has been shown in clinical studies to significantly reduce complication rates in patients receiving a lung biopsy procedure, which we expect will enable physicians to more aggressively pursue diagnostic options for this patient population."
Angiotech's Bio-Seal product is a novel biopsy device system that contains a proprietary hydrogel plug designed to prevent air leaks that can lead to a collapsed lung, or pneumothorax, in patients having lung biopsies. On contact with moist tissue, the hydrogel plug absorbs fluids and expands to fill the void created by the biopsy needle puncture. The plug is absorbed into the body after healing of the puncture site has occurred.
Pneumothorax is the most common potential complication in patients undergoing lung biopsy procedures. In cases where a chest tube is inserted to treat pneumothorax, an extended hospital stay for such patients may be required until the condition has stabilized. Industry estimates indicate that over 250,000 lung biopsy procedures are performed annually in the United States.
Bio-Seal has undergone a human clinical trial in the United States which was designed to assess the safety and efficacy of Bio-Seal, with the primary endpoint being reduction in rates of pneumothorax in patients undergoing lung biopsy procedures.
The clinical trial was a prospective, randomized, multi-centered safety and efficacy evaluation. The complete data for the Bio-Seal study was presented at the 2009 Society of Interventional Radiology.
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 expects that this product will be made commercially available in the U.S. during the first quarter of 2013. Angiotech expects market this product globally under the brand name "BioSentry™".
Angiotech is a British Columbia pharmaceutical company that discovers, develops and markets innovative technologies and medical products for local diseases or for complications related with medical device implants, surgical interventions and acute injury.