ST. JUDE GETS IDE APPROVAL TO BEGIN ESCAPE TRIAL

St. Jude Medical has received conditional approval from the FDA of an investigational device exemption (IDE) to begin enrollment in the Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere (ESCAPE) migraine trial.

ESCAPE is a prospective, randomized, two-arm, double-blind multicenter trial. The company said the intention of ESCAPE is to show if patients who undergo a patent foramen ovale (PFO) closure procedure have a decreased number of migraines over a one year follow-up period as compared to those who are maintained only on drug therapy. A PFO is a structural defect of the heart where a small hole between the right and left atria fails to close in infancy.

The ESCAPE trial will be conducted using the Premere PFO closure system -- a percutaneous transcatheter device that closes the PFO -- which St. Jude added to its portfolio through the acquisition of Velocimed in April. Enrollment in the study is expected to begin by the end of the year.