Medtronic announced on 8 May 2009 the successful implant of its Cardioblate Closure left atrial appendage (LAA) occlusion device by Dr Patrick McCarthy, codirector of the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital in Chicago, as part of an American clinical trial.
The study is being conducted under an investigational device exemption and the device is limited to investigational use in the USA.
Published literature suggests that the left atrial appendage is the main source of clots coming from the left atrium in patients with atrial fibrillation.
The trial involves five centres and will evaluate occlusion of the left atrial appendage with the Cardioblate closure device in patients undergoing valve replacement, valve repair or coronary bypass surgery.
McCarthy, the clinical trial’s principal investigator, said, “The clinical community urgently needs safe and proven therapies to achieve permanent closure of the left atrial appendage. The device was designed for quick, simple, complete occlusion of the appendage and we’re looking forward to verification of these qualities after completion of the trial.”
Medtronic’s Cardioblate Closure device is intended to occlude the left atrial appendage permanently without the need to enter the heart and does not introduce man-made materials into the blood stream. It is designed to be pliable and atraumatic to ensure no collateral damage to surrounding structures of the heart, unlike rigid epicardial occlusion devices.