Coronary implant for treatment of CAD granted breakthrough device status by FDA
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Key takeaways:
- The FDA granted breakthrough device designation status to a coronary implant for patients with CAD.
- In a randomized controlled trial, the implant was linked to fewer adverse events at 2 years vs. DES.
Elixir Medical announced its novel sirolimus-eluting coronary implant adaptable to vessel physiology was granted a breakthrough device designation by the FDA.
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 breakthrough designation is for an indication to improve coronary luminal diameter, hemodynamic modulation and plaque progression in patients with symptomatic ischemic heart disease due to de novo native coronary artery lesions, according to an industry press release.
The coronary implant (DynamX) is designed to restore the diseased vessel to a more normal condition through three phases. The first phase establishes the maximum flow lumen and restores blood flow. In the second phase, the coronary implant helical strands unlock, separate and release, allowing the vessel to grow and adapt to maintain blood flow lumen. In the third phase, the coronary implant provides dynamic support of the vessel and restores vessel viability and hemodynamic modulation, according to the release.
The two-year results of the BIOADAPTOR randomized controlled trial that compared the sirolimus-eluting coronary implant system with a contemporary drug-eluting stent (Resolute Onyx, Medtronic) were presented at EuroPCR 2024.
As Healio previously reported, the coronary implant was associated with less target lesion failure and target vessel failure at 2 years compared with the DES.
“For many years, it was thought that caging of the vessel with stents was the main driver for annual increasing non-plateauing event rates. However, the data with the ‘leave nothing behind’ approach with bioresorbable scaffold technologies showed non-plateauing event rates continue to occur even after resorption of the scaffold, so we needed a more innovative approach to restore vessel viability,” Motasim Sirhan, CEO of Elixir Medical, said in the release.
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