FDA grants breakthrough device designation for resorbable magnesium scaffold for CLTI
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Key takeaways:
- A below-the-knee resorbable magnesium scaffold to treat CLTI received FDA breakthrough device designation.
- When the device was implanted in coronary arteries, it was almost totally resorbed at 12 months.
Biotronik announced it was granted breakthrough device designation from the FDA its below-the-knee resorbable magnesium scaffold for the treatment of chronic limb-threatening ischemia.
The breakthrough device designation is intended to expedite the development and review of devices intended to treat a serious condition in which preliminary clinical evidence indicates potentially substantial improvement over available devices.
The magnesium alloy drug-eluting stent (Freesolve RMS) showed 99.6% degradation of magnesium at 12 months after implantation in coronary arteries, potentially making the device of particular value in below-the-knee interventions, according to a company press release.
“This breakthrough device designation for the Freesolve RMS for [below-the-knee] treatment is a significant milestone in advancing treatment options. Biotronik is committed to design our products to enhance the lives of patients," Ryan Walters, U.S. president at Biotronik, said in the release. "Our next-generation RMS represents a leap forward over existing resorbable technology, incorporating technical innovations intended to address physicians' needs and optimize outcomes for patients suffering from CLTI.”
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