Amy J. Reed Collaborative/HARMS Petition HHS and FDA to Restrict Deployment of enVast Heart Device Pending Further Clinical Research

Professors David Simon and Hooman Noorchashm have filed a citizen petition with the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration requesting urgent action regarding a recently cleared heart device called enVast.

Amy J. Reed Collaborative/HARMS Petition HHS and FDA to Restrict Deployment of enVast Heart Device Pending Further Clinical Research

03.25.26 —Northeastern Law professors David A. Simon and Hooman Noorchashm, who serve as co-directors of the Amy J. Reed Collaborative for Medical Device Safety (AJRC) and Harmed Americans for Reform in Medical-Device Safety (HARMS), have filed a citizen petition with the U.S. Department of Health and Human Services (HHS)  and the U.S. Food and Drug Administration (FDA) requesting urgent action regarding a recently cleared heart device called enVast, a first-of-its-kind coronary thrombectomy system manufactured by Vesalio Inc.

The petition contends that the FDA cleared enVast in November 2025 without including any supporting clinical data proving its safety or effectiveness in human patients, and that the manufacturer has publicly promoted the device — used during emergency heart attack procedures to remove dangerous blood clots from coronary arteries — as proven, safe and effective even though its own instruction label warns that its safety and effectiveness “have not been established.” The petition calls on the FDA to require a properly supervised clinical trial before broader patient use continues, mandate post-market safety surveillance, investigate the manufacturer's promotional claims and restrict the device's approved uses to last-resort cases where standard treatments have already failed — warning that allowing an unproven device to be marketed broadly to critically ill heart attack patients puts lives at risk and undermines the integrity of the FDA clearance process.
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“FDA's 510(k) process allows for clearance of new and non-standard medical devices into areas of clinical practice, where a standard of care device is already being used,” said Noorchashm, an internationally recognized medical device safety expert. “This 510(k) permissiveness is potentially dangerous to U.S. public health - because often, the FDA's 510(k) clearance process does not require the manufacturer to demonstrate that the new, non-standard device is safe, effective and non-inferior to the existing standard. Advertising such a device as safe and effective can confuse healthcare providers and patients about the evidence supporting its use. This problem is yet another demonstration that 510(k) is an intrinsically unsafe and problematic regulatory mechanism.”

“Frequently devices come through the 510(k) process with no supporting clinical evidence,” said Simon, a healthcare law expert. “Providers and patients should understand that a manufacturer’s promotional statements about a cleared device may not be based on the same standards of evidence that physicians and medical societies rely on to ensure they deliver safe and high-quality patient care.”

The Amy J. Reed Collaborative for Medical Device Safety, a joint venture of Northeastern Law and Tufts Medical Center, is a pioneering academic and activist initiative focused on advancing medical device safety through increased awareness, fostering collaboration and facilitating resource sharing among patients and industry experts. Its mission is to drive positive change in the field by advocating for safer medical devices and promoting transparency and accountability. Harmed Americans for Reform in Medical-Device Safety (HARMS) is a 501(c)(3) not-for-profit corporation. Its mission is to advance medical device safety through advocacy, outreach and organizing.

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