Heart Valve Rings Approved Without Clinical Trials

A popular heart device recommended for implantation in patients never underwent clinical trials. The painstaking tests are typically called for when a new medical device is presented to the U.S. Food and Drug Administration (FDA) for approval for patient use.

The Chicago Tribune conducted an investigation regarding <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">annuloplasty rings, used in heart valve repairs and typically recommended when a faulty heart valve need replacement. Both replacement heart valves, which have received FDA approval, and annuloplasty rings, which are implanted without FDA approval, require permanent stitching into the heart, noted the Tribune.

Ten years ago, the agency issued a downgrade on the medical class containing the heart rings, separating them from heart valves and implantable pace makers and including them with “catheters, sutures, and hearing aids,” explained the Tribune. This enables the “life sustaining” devices to be approved with no clinical studies, a boon for the medical device industry. “It’s absolutely ridiculous. How could something that is permanently implanted in the heart be regulated this way?” said Diana Zuckerman, president of the National Research Center for Women & Families, quoted the Tribune; the Center works for more stringent medical device supervision. “The first question is: Who petitioned this change and what financial interest did they have?” Zuckerman added.

According to the Tribune, its review revealed that the Advanced Medical Technology Association, or AdvaMed, an industry group that represents device makers, received FDA approval on its petition to enable the heart devices—implanted in thousands, said the Tribune—to be approved without testing. The invasive devices are linked with more deaths in the past five years alone that any other device in its class, said the Tribune, citing its review of FDA adverse event data.

Following the annuloplasty ring reclassification, other makers introduced many new, very high priced models that also do not need to undergo the time and cost of a clinical trial, said the Tribune. The reclassification also enabled two more heart ring models to be implanted in some 700 patients without FDA clearance or knowledge, the Tribune pointed out. According to Edwards Lifesciences, maker of these device, clearance was not mandated as the rings were substantially similar to existing models.

But, noted the Tribune, Edwards Lifesciences, filed a number of patent applications that list 40 ways in which the devices were different from existing devices. “The present invention provides a novel annuloplasty ring for correcting pathologies associated with mitral valve prolapse,” the patent reads, quoted the Tribune. While the agency conceded that the firms should have applied to clearance, the firm was not punished and has enjoyed a rise in net income by a massive 70 percent in the past three years.

Under the law, the rings, a Class II device, can easily receive FDA clearance if the device maker can prove the product is “substantially equivalent” to existing, approved devices, quoted the Tribune. To minimize administrative work, the FDA does permit new devices to avoid clearance if the devices contain the same “labels, technology and materials” as cleared devices, noted the Tribune. This is the case with the Edwards Lifesciences Myxo and IMR rings.

We’ve long written about medical devices hitting the market via a legal process that involves fast-tracking, a process which has been roundly criticized by many nonindustry advocates concerned with potentially defective devices making their way into patients’ bodies.

Thousands of medical devices are approved annually in the United States with no proof of efficacy. The FDA defends the practice, commonly known as known as 510(k) approvals, claiming it promotes innovation. The FDA’s policy of fast-tracking medical devices contrasts greatly with its process for drug approvals in which the FDA requires new medications be studied in thousands of people to determine safety and efficacy prior to approval for market release. By contrast, medical device makers must simply demonstrate a device does what they claim, and that it poses no undue safety risks; proof of efficacy is not required.

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