Amplatzer… Looking Good, But Not “That” Good?

In short

Back in July St.Jude CEO Dan Starks got into a little hot water by jumping the gun on the outcome of the company’s RESPECT PFO study into closure of patent foramen ovale. At the time, we (among others) questioned the wisdom of so doing in our piece which can be found here. It seems we may have had a point because the company’s share price fell a little yesterday following release of the clinicals, which were not quite as rosy as the market had clearly built in following Starks’ comments.


Up to 40% of ischemic strokes are classified as cryptogenic, a stroke of unknown cause, and the prevalence of PFO is up to three times greater in this population. So establishing whether closure of PFO using a minimally invasive device would seem like a good idea and was the main purpose of the St.Jude study.

The company has this week seen results from its RESPECT trial presented at TCT 2012. The study focused on the Amplatzer™ PFO Occluder in the prevention of recurrent cryptogenic stroke and shows that the primary analysis was not statistically significant but trended towards superiority, while additional analyses demonstrated superiority. Stroke risk reduction was observed across the totality of analyses with rates ranging from 46.6 percent – 72.7 percent.

St.Jude’s full press release on the study can be found here, but if you’re looking for the reasons why investors took a slightly dimmer view than St.Jude, the boss’s words back in July are the key. Back then he said; “In stark contrast to prior randomized trials of competitive PFO devices for mitigation of risk in cryptogenic stoke patients, we are confident our trial will demonstrate greater benefit and less risk in the device arm of the trial.”

The lack of statistical significance in the clinical data doesn’t mean he’s wrong. Indeed as more data analysis is performed it may well become significant, but the investment community is obviously not convinced just yet… the share price was almost 5% down by close of trading yesterday.

Physician comments

“The patient population affected by cryptogenic stroke tends to be relatively young and healthy. PFO closure with the AMPLATZER PFO Occluder is potentially a novel prevention strategy that may be superior to medications alone,” said Dr. John D. Carroll, director of the Cardiac and Vascular Center and Interventional Cardiology at the University of Colorado, who presented the data at TCT. “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.”

Source: St.Jude Medical, Inc.