The device is designed to treat a condition called patent foramen ovale, in which a naturally-occurring hole in the heart fails to close after birth, potentially allowing blood clots to travel from 1 side of the heart to the other and then to the brain, causing a stroke.
The St. Paul-based medical device company sponsored the larger study, of 980 patients, which tracked them at intervals of 1 month, 6 months, 12 months, 18 months, 24 months and then annually until 25 strokes or deaths occurred. It showed that 9 patients in the Amplatzer arm suffered non-fatal strokes, compared with 16 for the drug treatment cohort. There were no deaths or fatal strokes in either arm.
St. Jude was quick to point out that a quirk in the study’s design meant that 3 of the 9 patients in the study who never received the implant were included in the Amplatzer arm. Excluding those patients, and patients in the drug treatment cohort who dropped drug therapy, and the risk of stroke was 63% lower for patients treated with the Amplatzer device.
“Stroke is a devastating disease and we now have compelling evidence that shows a 46 to 72 percent risk reduction in recurrent strokes, which is meaningful for this otherwise healthy patient population with a long life expectancy,” co-principal investigator Dr. John D. Carroll of the University of Colorado said in prepared remarks.
“We are pleased with the results of the RESPECT trial and remain confident in the safety and performance of the Amplatzer PFO Occluder and the strength of our clinical trial design,” added St. Jude’s cardiovascular & ablation president Frank Callaghan.
STJ shares were down 4.0% to $38.11 apiece as of about 1 p.m. today on the news, as investors reacted to overly rosy expectations for the trial set by St. Jude CEO Daniel Starks. During a conference call in July, Starks said St. Jude was “confident our trial will demonstrate greater benefit and less risk in the device arm of the trial.”
“On the PFO closure, the submission to FDA is being prepared as we speak, and there’s a lot of data to analyze and prepare and organize,” he said during a conference call with analysts. “I would be confident that the PMA submission will be in during the 4th quarter, and I suspect that we would be unlikely to get that submission in before the end of the 3rd quarter. So timing-wise, that’s our update. Within that though, one can see that we have a number – since we – our organization is strongly focused on preparing that submission, obviously, we’re no longer blinded to the data, and that was the basis for level of confidence we’ve expressed, that when the full trial results are reported at the TCT, we’re optimistic that these will be favorable results.”