The Food & Drug Administration granted 510(k) clearance to Boston Scientific Corp.‘s latest-generation WallFlex bile duct stent, and the Natick, Mass.-based medical device giant announced a new defibrillator clinical trial.
BSX said the FDA nod toward its WallFlex Biliary RX fully and partially covered stents means all three WallFlex models — the fully covered, partially covered and uncovered versions — are on the market in the U.S. and Europe.
Boston Scientific Endoscopy president Michael Phalen said the latest WallFlex stent leverages existing technology with its platinum-core nitinol construction.
BoSci also said it began enrolling patients in a clinical trial examining the optimum programming for implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, the MADIT-RIT study, they performed certain Cardio Workouts to see how their body responds.
The trial aims to determine how to best program the devices to avoid unnecessarily shocking hearts in patients with no history of cardiac arrest. The prospective, randomized tril will enroll 1,500 patients in about 75 centers around the world.