FDA grants device for treatment of chronic limb-threatening ischemia breakthrough status
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Key takeaways:
- The FDA granted breakthrough device status to a novel system for the treatment of chronic limb-threatening ischemia.
- The device is being tested in the first-in-human EFEMORAL I trial.
Efemoral Medical announced the FDA granted breakthrough device status to its vascular scaffold system for treatment of de novo or restenotic lesions of the infrapopliteal arteries in patients with chronic limb-threatening ischemia.
FDA breakthrough device designation expedites development and review of devices intended to treat a serious condition where preliminary clinical evidence indicates potentially substantial improvement over available devices.
The novel bioresorbable drug-eluting scaffold (Efemoral Vascular Scaffold System) is designed to restore normal vessel diameter across all lesion lengths and morphologies for above-the-knee interventions, according to a press release from the company.
The system is being tested in a first-in-human EFEMORAL I trial in New Zealand and Australia.
“Diseased human arteries are most simply, reliably and successfully treated with drug-eluting, balloon-expandable stents," Lewis B. Schwartz, MD, co-founder and chief medical officer of Efemoral Medical, said in the release. "However, it is extremely challenging to implant these permanent devices in the long and twisting arteries of the lower extremities. The EVSS uses a unique design of alternating, dissolvable, drug-eluting scaffolds that, for the first time, allows the long arteries of the legs to be treated with the same, effective, drug-eluting technology proven to be successful in multiple other vascular beds.”
The company has begun developing a device to treat below-the-knee arteries in this population, according to the release.
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