In Brief: Possis Medical AngioJet
This article was originally published in The Gray Sheet
Executive SummaryPossis Medical AngioJet: First patient treatment with water-propelled thrombectomy system performed at Boston's Beth Israel Hospital. The initial procedure "successfully removed blood clot and other obstructive material from a severely degenerated bypass graft," according to the firm, prior to a "planned multiple coronary stent placement." Beth Israel is one of four U.S. clinical sites approved for the Phase I study, which is expected to involve approximately 60 procedures...
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.