Novel Bioadaptor Implant Shows Promise Over Traditional Heart Stents
Key Insights
Elixir Medical (search)'s DynamX bioadaptor demonstrates potential improvement over traditional stents by adapting to artery's natural motion and blood flow after angioplasty.
A year-long trial involving 2,399 heart disease (search) patients in Sweden showed lower rates of heart attacks and repeat procedures with the bioadaptor compared to drug-eluting stents.
Research identifies microvascular inflammation as an early sign of kidney transplant rejection, emphasizing the need for modified treatment approaches.
A new bioadaptor implant, Elixir Medical (search)’s DynamX, is showing promising results as a potential improvement over traditional heart stents. The device is designed to prop open heart arteries after interventions to unclog them, adapting over time to allow restoration of the artery’s natural motion.
How the Bioadaptor Works
Initially, the DynamX bioadaptor functions similarly to a conventional stent, maintaining its shape and releasing a drug to prevent reclogging following an angioplasty procedure. Over a six-month period, its coating is resorbed, and the chromium-cobalt strands supporting the device separate. This separation allows the artery to grow, adapt to the new blood flow, and resume its natural functions while still providing dynamic support to the vessel.
Clinical Trial Results
In a year-long trial conducted in Sweden, involving 2,399 patients with heart disease (search), the bioadaptor was associated with lower rates of heart attacks originating from the original blockage site, reduced need for repeat unclogging procedures, and decreased heart-related deaths compared to Medtronic’s widely used drug-eluting stent. These benefits were observed across the entire trial population and in high-risk subgroups. The results were presented at the Transcatheter Cardiovascular Therapeutics conference in Washington and published in The Lancet.
The researchers plan to continue following the study participants for five years to assess long-term outcomes.
Regulatory Status and Potential Impact
The Elixir device received breakthrough designation from the U.S. Food and Drug Administration (FDA) in June, indicating that the agency considers it a potentially significant advancement in the field. According to researchers, "The available evidence suggests that the bioadaptor might become a promising treatment with the potential to mitigate the high occurrence of stent-related events."
Identifying Early Signals of Kidney Transplant Rejection
In a separate study presented at the American Society of Nephrology’s Kidney Week meeting in San Diego, researchers identified microvascular inflammation as a previously unrecognized early signal of kidney transplant rejection. The study, led by Dr. Vikas Dharnidharka of Rutgers Robert Wood Johnson Medical School, revealed that inflammation in the tiniest blood vessels around the kidneys predicts future complications.
Analysis of over 16,000 biopsies from 6,798 kidney recipients in Europe and North America between 2004 and 2023 showed that patients with microvascular inflammation, but without other typical signs of rejection, had more than twice the five-year graft-failure risk compared to patients with no signs of organ rejection. Additionally, patients with mild inflammation and minimal antibodies present were nearly three times as likely to experience graft failure.
Jardiance's Long-Term Benefits for Kidney and Heart Health
Research presented at the Kidney Week meeting also examined the long-term effects of Jardiance (empagliflozin) on kidney and heart health in patients with chronic kidney disease (search). The study, a follow-up to a randomized trial, found that while some protective effects of the drug were still evident two years after patients completed the trial, the benefits waned over time. This indicates that long-term treatment with Jardiance and other SGLT2 inhibitors is necessary to maximize their protective effects on the kidneys and heart.
Of the 6,609 patients in the original two-year trial, 4,891 enrolled in a two-year follow-up study. During the combined active- and post-trial periods, kidney disease progression or a cardiovascular event occurred in 26.2% of the empagliflozin group and in 30.3% in the placebo group. During the post-trial period only, the odds of one of those outcomes was 13% lower in the Jardiance group.
According to the researchers, the carryover effect was less than the effect of receiving empagliflozin during the active-trial period and appeared to last for up to 12 months, with most additional benefit seen in the first 6 months after the active trial ended.