A new device to prop open heart arteries after interventions to unclog them adapts over time to allow restoration of the artery’s natural motion and may be an improvement over traditional stents, according to data presented at a medical meeting.
Initially, Elixir Medical’s DynamX bioadaptor acts like a conventional stent, holding its shape and releasing a drug to prevent reclogging following an angioplasty procedure.
But over six months, its coating is resorbed and the chromium-cobalt strands that support the device separate, allowing the artery to grow, adapt to the new blood flow, and resume its natural functions while continuing to provide dynamic support to the vessel, according to the manufacturer’s website.
In a year-long trial of 2,399 patients with heart disease in Sweden, the bioadaptor was associated with lower rates of heart attacks caused by the original site of the blockage, need for a repeat unclogging procedure, or heart-related death than Medtronic's widely used drug-eluting stent, researchers reported at the Transcatheter Cardiovascular Therapeutics conference in Washington.
The benefits were seen in the overall trial population as well as in high-risk subgroups, the researchers noted. The trial results were also published in The Lancet.
The researchers said they plan to follow these study participants for five years.
The Elixir device received breakthrough designation from the U.S. Food and Drug Administration in June, meaning the agency regards it as a potentially important advance in the field.
“The available evidence suggests that the bioadaptor might become a promising treatment... with the potential to mitigate the high occurrence of stent-related events,” the researchers said.