Boston Scientific has initiated the US and international launch of its WallFlex biliary transhepatic stent system, along with a percutaneous delivery system, designed for use by interventional radiologists in the palliative treatment of biliary strictures produced by malignant tumours.
The WallFlex biliary transhepatic stent system is available in fully covered, partially covered and uncovered versions in multiple sizes, to accommodate different anatomical and clinical requirements.
The covered stents have a silicone polymer Permalume coating designed to reduce the potential for tumour / tissue growth, and an integrated retrieval loop for endoscopic removal or repositioning during the initial procedure.
The WallFlex biliary RX stents and the WallFlex biliary transhepatic stents are CE marked, for the treatment of benign biliary strictures, and have received Food and Drug Administration clearance for the palliative treatment of malignant biliary strictures.
The safety and effectiveness of the WallFlex biliary RX and WallFlex biliary transhepatic stent systems for use in the vascular system have not been established.
Johns Hopkins University, US, professor Kelvin Hong said the WallFlex Stent technology, originally designed for gastroenterologists, is now available for interventional radiologists and patients they typically treat through percutaneous procedures.
"The WallFlex biliary transhepatic stent system offers the latest advances in self-expanding metal stent technology with a delivery system designed specifically for the interventional treatment of malignant biliary strictures," Hong added.
Boston Scientific Endoscopy Division president David Pierce said, by providing interventional radiologists with a third-generation stent platform supported by clinical evidence and innovative features, the company continues to deliver industry-leading technologies that improve patient quality of life.
"The launch of the WallFlex biliary transhepatic stent system extends the ability of this technology to treat more patients with biliary strictures," Pierce added.
Boston Scientific is a developer, manufacturer and marketer of medical devices used in a broad range of interventional medical specialties.