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Reconditioned Pacemakers Show Similar Performance to New Devices in Clinical Trial

9 months ago2 min read

Key Insights

  • A randomized trial revealed that reconditioned pacemakers are as safe and effective as new ones after 90 days, suggesting a cost-effective alternative for low- and middle-income countries.

  • The FDA permits the export of re-sterilized pacemakers for reuse, even though the practice is prohibited in the U.S., highlighting potential global health implications.

  • An NIH-developed AI algorithm, TrialGPT, can efficiently match volunteers to clinical trials, summarizing eligibility criteria and potentially accelerating clinical research.

A recent randomized trial has demonstrated that reconditioned pacemakers perform comparably to new devices in terms of safety and efficacy. The study offers a potentially affordable solution for patients in low- and middle-income countries where access to these life-saving devices is limited.
The trial, which compared previously used pacemakers to brand new models over a 90-day period, found no significant difference in performance. This suggests that reconditioned devices could serve as a viable alternative in regions where cost is a major barrier to access.

Addressing Global Disparities in Pacemaker Access

"Access to pacemakers is limited in many low- and middle-income countries due to the relatively high cost of the devices," said Dr. Thomas Crawford, lead author of the study. He noted that while high-income countries may implant pacemakers in as many as 1,000 people per million annually, low-income countries may only reach 3 per million.
While the reuse of pacemakers is prohibited in the U.S., the FDA allows re-sterilized devices to be exported for reuse, acknowledging the potential benefit to underserved populations globally.

NIH Launches AI Tool to Accelerate Clinical Trial Recruitment

In other news, the National Institutes of Health (NIH) has developed an artificial intelligence (AI) algorithm called "TrialGPT" designed to streamline the process of matching volunteers to clinical research trials. The AI is able to identify relevant clinical trials for which a volunteer is eligible, in addition to providing a summary that explains how the volunteer matches the criteria.
"This study shows we can responsibly leverage AI technology so physicians can connect their patients to a relevant clinical trial that may be of interest to them with even more speed and efficiency," said Stephen Sherry, PhD, NIH National Library of Medicine (NLM) director.

Kratom Availability and Concerns

Despite concerns about liver toxicity, seizures, and death, Kratom remains readily available in nearly 75% of tobacco and vape stores across the U.S., according to a new study from the University of Mississippi. More than two million Americans use the substance annually.
"Kratom products are marketed or advertised as having various benefits from use, from therapeutic benefits to being stimulants or depressants, to pain relieving, to even being a substitute for opioids," said Matthew Rossheim, associate professor and lead researcher on the study. "Because of the lack of scientific evidence, those are potentially deceptive claims."
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