Novel implant for below-the-knee treatment of CLTI gains breakthrough device designation
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Key takeaways:
- A novel implant for below-the-knee treatment of chronic limb-threatening ischemia gained breakthrough device designation.
- The device is designed to support the blocked vessel during healing and improve function.
Elixir Medical announced it received breakthrough device designation from the FDA for its novel adaptive implant for the treatment of narrowed or blocked below-the-knee vessels in patients with 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 metallic device (DynamX BTK System) is designed to support the vessel during healing, after which it unlocks and “uncages” the vessel, providing dynamic support, restoring vessel function and maintaining an open lumen, according to a company press release.
"The Bioadaptor platform was developed to transform treatment of coronary and peripheral artery disease,” Motasim Sirhan, CEO at Elixir Medical, said in the release. “We appreciate the FDA recognition of our innovation for treating the CLTI population with BTK disease and its potential impact on the patients suffering from vascular disease.”
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