US-based medical technology developer St Jude Medical has presented additional data from a prospective, randomised, event driven-study of its transcatheter patent foramen ovale (PFO) closure device.
Comprised of Nitinol mesh and polyester fabric, the double-disc Amplatzer PFO occluder device is designed to close all types of PFOs with an easy-to-perform deployment procedure.
The 980-patient trial, RESPECT, was designed to determine if PFO closure with the Amplatzer PFO occluder plus medical management was superior over medical management alone in the prevention of recurrent cryptogenic (unknown cause) stroke.
David Geffen School of Medicine neurology professor and UCLA Stroke Centre director Dr Jeffrey Saver said data from the trial indicates that patients with a device were less likely to suffer stroke, had smaller strokes, and were less likely to have the type of stroke linked to paradoxical embolism.
"Indications of preventing strokes on the surface of the brain and large strokes provide additional evidence of a genuine biological effect of closure with the Amplatzer PFO occluder in preventing recurrent cerebral infarcts due to a blood clot crossing through the PFO," Saver said.
The objective of analysing the additional data from the trial was to determine if patients in the device and medical therapy group suffered different types of recurrent strokes, and to identify the potential origin of the strokes, according to the company.
The results demonstrated that patients with a device in place were less likely to suffer another stroke, while patients in the medical group experienced larger strokes.
St Jude Medical cardiovascular and ablation technologies division president Frank Callaghan said; "The overall trial demonstrates that PFO closure with the Amplatzer PFO occluder for these relatively young, otherwise healthy patients substantially reduces their risks of suffering another stroke."
The company presented the additional study data at the American Stroke Association’s International Stroke Conference 2013, held in Honolulu, Hawaii, US.