The device will be used to close the left atrial appendage (LAA) in patients who cannot receive chronic oral anticoagulation therapy (OAC) and will minimise the risk of stroke in patients with atrial fibrillation (AFib).
Set to recruit 1,250 subjects at around 90 hospitals, the trial’s first patient was treated by NYU Langone’s Heart Rhythm Center director Larry Chinitz at the New York University (NYU) Hospital in the US.
Dr Chinitz said: “The WaveCrest System is designed to enable physicians to close the heart’s LAA, where most stroke-causing blood clots occur.
“For patients with AFib seeking an alternative to anticoagulants or blood thinners, this may be an important procedural option that could reduce the risk of stroke and save lives.”
The prospective, multi-centre, randomised, active-controlled WaveCrest IDE trial will compare the LAAO system to an existing US Food and Drug Administration (FDA) approved LAA closure device to reduce embolic stroke risk in patients suffering from non-valvular atrial fibrillation.
Johnson & Johnson Medical Devices Cardiovascular & SPECIALTY SOLUTIONS company group chairman Shlomi Nachman said: “Preventing and reducing the risk of stroke in AFib patients is a significant unmet need.
“We are committed to investing in meaningful innovation and are excited by the prospect of bringing the WaveCrest System to the US market so that more patients can benefit.”
Biosense Webster focuses on developing products for the diagnosis and treatment of heart rhythm disorders, and collaborates with clinicians to create technologies for improved quality of care in arrhythmia patients.