Humacyte from Biotech Company conducted a study to assess the effectiveness of their lab-grown blood vessels by measuring the flow through a high-tech tube implanted in patients 30 days later.
During the study, some patients encountered difficulties, with reports of deaths and amputations due to blood clots and infections in the artificial vessel.
Despite these setbacks, Humacyte considered these cases as successes in investor meetings, but the FDA viewed them as failures due to insufficient data on vessel patency.
The vessel was approved by the FDA without public review, despite concerns about adverse outcomes when the vessel disintegrated.
Humacyte is now focusing on marketing their vessel to hospitals and the military, aiming to provide an alternative for damaged blood vessels.
The company’s lab-grown vessels are made from collagen and have been developed over two decades, with hopes to revolutionize vascular surgery.
Despite concerns raised by FDA reviewers, the company is optimistic about the vessel’s potential benefits and plans to expand its distribution.
Dr. Robert E. Lee, a vascular surgeon with decades of experience, has raised concerns about the vessel’s safety profile and believes the risks outweigh the potential benefits.
The FDA has approved the vessel based on clinical trial data demonstrating improved blood flow in affected limbs, but critics question its safety and efficacy.
Dr. Laura Niklason, the company’s founder, celebrates the vessel’s approval as a milestone in regenerative medicine, despite the controversies surrounding its performance.
Source: www.nytimes.com