AtriCure’s AtriClip device for occlusion of the Left Atrial Appendage(LAA), with consequent reduction in risk of clot formation and transmission, can currently only be used (according to its approval) in conjunction with other open surgical procedures in which the operator has direct visualisation. MedCity News, a vehicle which covers medical device news from USA’s major Medtech centres, has reported that AtriCure is now working to gain approval for use of the device in a minimally invasive fashion in stand-alone procedures to close the LAA.
According to the report; “The Cincinnati-area company is planning next year to begin a clinical trial that will investigate the AtriClip for use in stand-alone procedures that involve exclusion of the left atrial appendage, a thumb-sized pouch on top of the left side of the heart from which blood clots that cause strokes often originate.”
The full article can be found here.
Of potential interest to European operators, the current restriction to use in open procedures also extends to the products CE Mark approval. Alongside it’s quest for approval the company is working on instrumentation to facilitate Thoracoscopic introduction of the device.
This item follows closely behind news of Boston Scientific’s percutaneously delivered WATCHMAN® device which is also chasing FDA approval (see related posts below).
Source: MedCity News, medlatest staff