FDA grants device for treatment of chronic limb-threatening ischemia breakthrough status

The FDA has granted breakthrough device status to Efemoral Medical’s novel vascular scaffold system for the treatment of chronic limb-threatening ischemia. The system, called Efemoral Vascular Scaffold System, is designed to restore normal vessel diameter across all lesion lengths and morphologies for above-the-knee interventions. It uses a unique design of alternating, dissolvable, drug-eluting scaffolds and is being tested in the first-in-human EFEMORAL I trial in New Zealand and Australia. The company has also begun developing a device to treat below-the-knee arteries in this population. Breakthrough device designation expedites the development and review of devices intended to treat serious conditions with potentially substantial improvement over available devices.

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