A 10-year-old whistleblower lawsuit filed by a former Abbott (NYSE:ABT) sales rep, over the alleged off-label marketing of biliary stents, finally went to trial in Dallas yesterday. Plaintiff Kevin Colquitt, a former rep for Abbott’s Guidant division, sued Abbott, Johnson & Johnson (NYSE:JNJ) and Boston Scientific (NYSE:BSX) in 2006, claiming that they marketed the use of biliary stents to treat peripheral artery disease. (The magistrate overseeing […]
Biliatrics
Boston Scientific ponies up $63m for Xlumena
FDA clears new version of Boston Scientific’s SpyGlass
Boston Scientific (NYSE:BSX) said the FDA granted 510(k) clearance for the latest iteration in its line of cholangioscopy and pancreatoscopy devices, the SpyGlass DS.
Xlumena wins FDA nod for Axios pancreatic stent
Xlumena won FDA approval to market its Axios stent and delivery system, landing approval through the FDA’s less-stringent de novo review pathway.
The stent is the 1st specifically designed for the drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.
FDA expands clearance for Intuitive Surgical’s FireFly imaging system
Intuitive Surgical (NSDQ:ISRG) said the FDA expanded the 510(k) clearance for its FireFly fluorescence imaging system to use during gallbladder surgery using its da Vinci robotic surgery device.
Boston Scientific hits new 52-week high on WallFlex stent trial launch
Boston Scientific (NYSE:BSX) shares hit a new 52-week high today after the medical device company announced the launch of a clinical trial of its WallFlex biliary stent.
St. Jude, Boston Scientific log clinical milestones
Boston Scientific sues Cook, Korean firms in patent suit
Boston Scientific Corp. (NYSE:BSX) sued Cook Group, a slew of its subsidiaries and a group of Korean firms, alleging infringement of four endoscopic stent patents covering devices to treat the digestive system.
The lawsuit, filed in the U.S. District Court for Massachusetts, accuses Warsaw, Indiana-based Cook and the subsidiaries (including Cook Ireland Ltd.) of violating the quartet of patents with its Evolution stenting system, according to court documents.
Viking, Boston Scientific extend supply contract
Viking Systems Inc. (OTC:VKNG) extended its supply contract with Boston Scientific Corp. (NYSE:BSX).
The Westborough, Mass.-based company provides the camera, light source and accessories designed specifically for Boston Scientific’s SpyGlass direct visualization system.
Boston Scientific begins biliary stent trial
Boston Scientific Corp. (NYSE:BSX) enrolled the first patient in a clinical trial of its WallFlex biliary stent for the treatment of benign bile duct strictures.
The Natick, Mass.-based medical device colossus said it plans to enroll 187 patients at 11 centers worldwide over the next 18 months for the trial, which will evaluate the removal of the stents from patients with benign bile duct strictures and the effectiveness of temporary stenting for long-term, benign biliary stricture resolution.