CardioVascular Dynamics' Lynx catheters cleared by FDA:
This article was originally published in Clinica
CardioVascular Dynamics Lynx coronary catheters have been cleared by the FDA for marketing in the US. The company can now sell eight different models of its Lynx over-the-wire catheter for the treatment of atherosclerosis. The condition blocks blood flow within coronary arteries.
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.