UPDATED: St. Jude claims 'landmark study' quells concerns over heart plug benefits

St. Jude Medical's Amplatzer PFO Occluder--Courtesy of St. Jude Medical

While two recent studies challenged the effectiveness of St. Jude Medical's ($STJ) heart plug, the company is promoting final results of its own 8-year trial that say otherwise.

St. Jude said its results from the RESPECT trial for the Amplatzer PFO Occluder showed the device worked better than antiplatelet medications or warfarin alone to prevent strokes in patients with a patent foramen ovale. Interestingly, patients implanted with the device experienced a risk reduction for recurrent strokes of between 51% and 73%, and researchers met their primary endpoints. (But researchers did not record statistically significant differences in either group's incidence of serious adverse events.)

Sixty-nine U.S. and Canadian medical centers took part in a 980-patient prospective, controlled, randomized study. There were no statistically significant differences in the incidence of any serious adverse event between the two groups.

Amplatzer is designed to stop future strokes by plugging the patent foramen ovale, a hole between the heart's upper chambers that is a common heart birth defect. Left untreated, its presence can allow blood clots to pass from the heart to the brain, leading to a stroke, the company notes.

St. Jude was quick to tout the results as solid proof that addresses any concerns.

"The totality of evidence from this study, including the strong performance and safety profile of the device, demonstrates the compelling clinical benefits of closure versus medical management in reducing the likelihood of recurrent strokes in this patient population," Frank Callaghan, president of St. Jude Medical's Cardiovascular and Ablation Technologies Division, said in a statement.

Certainly, the company hopes the trial results, published in The New England Journal of Medicine, will help protect the product's future. It generates $100 million in revenue each year with 9,000 or so annual procedures. But two new studies unveiled in October heightened concerns about Amplatzer. Based on 12 years of data from stroke patients, they found that the device didn't significantly reduce the risk of a second stroke compared to regular drug treatments.

Editor's note: this story has been updated in the last paragraph to more accurately reflect previous studies regarding St. Jude Medical's Amplatzer device.

- read the release
- here's the NEJM abstract

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