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Elixir Medical has announced the company’s novel bioadaptive implant, DynamX Sirolimus-Eluting Coronary Bioadaptor System, has been granted Breakthrough Device Designation by the U.S. After implantation, the locked phase establishes the maximum flow lumen and restores blood flow to treat symptoms of coronaryarterydisease (CAD).
CLTI is the most severe form of peripheralarterialdisease (PAD), estimated to affect 11% of the 200 million people suffering from PAD globally. degradation of magnesium observed 12 months after implantation in coronaryarteries.4 2,3 It has shown 99.6%
The company reports this broadens the use of the novel bioadaptor platform technology beyond the treatment of coronaryarterydisease. The DynamX Bioadaptor platform is a medical technology designed to establish the new standard of care for vascular interventions, according to a written statement on the designation.
1 Atherosclerosis is a systemic disease that affects multiple vascular regions and is particularly severe in PAD patients, where up to 80 percent suffer from concurrent coronaryarterydisease (CAD), historically linked with a mortality rate exceeding 50 percent within five years. Journal of Vascular Surgery, Mar.
Joaquin Duato , Chairman and Chief Executive Officer of Johnson & Johnson, said, “Through Innovative Medicine and MedTech, Johnson & Johnson is transforming the trajectory of cardiovascular disease, one of the leading causes of death globally.
With the addition of Shockwave, Johnson & Johnson will expand its MedTech cardiovascular portfolio into two of the highest-growth, innovation-oriented segments of cardiovascular intervention – coronaryarterydisease (CAD) and peripheralarterydisease (PAD).
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