Guidant seeks US OK for cobalt chromium stent:
This article was originally published in Clinica
Guidant has submitted to the US FDA a premarket approval (PMA) application for permission to market its Multi-Link Vision coronary stent system. The device, the company's seventh-generation Multi-Link stent platform for the treatment of coronary artery disease, is constructed of a cobalt chromium alloy, enabling the stent to have thinner stent struts and enhanced deliverability while maintaining "excellent" radial strength and visibility, says the firm. The company plans to use cobalt chromium stents in future drug eluting stent platforms.
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.