A significant benefit of the OccluNova implant is that the left atrial appendage can be safely and completely occluded in more patients, allowing more patients to safely stop taking oral anti-coagulation (OAC) therapy.
In addition to lifestyle changes to reduce the risk of uncontrollable bleeding events, OAC therapy requires constant monitoring by medical professionals to ensure prothrombotic times (INR) are in therapeutic ranges without overly exposing patients to bleeding events (intracranial hemorrhage and gastrointestinal bleeding, in particular).
Average annual cost to simply monitor INR levels in the US is $1,500. A 2013 meta-analysis conducted on US-based studies showed that the annual incremental cost of treating AF with OAC ranged from $8,705 to $16,311, and annual in-patient costs ranged from $7,841 to $22,582 per patient.
One-year costs of treating major bleeding events caused by OAC therapy (e.g. intracranial hemorrhage and gastrointestinal bleeding) ranged from $7,584 to $193,804. Surely these costs have risen over the past 10 years, and are likely to continue to rise. Allowing more patients to safely discontinue OAC therapy will be a tremendous savings in healthcare spending, as well as a meaningful improvement in quality of life for affected patients.
First-generation left atrial appendage closure (LAAC) devices have shown considerable promise in allowing AF patients to safely terminate OAC therapy. However, limitations exist that affect safety, effectiveness, suitability for a greater number of patients. The next generation of LAAC technology must address these shortcomings.
Instead of a rigid nitinol frame, the OccluNova implant is made from a pliable polyurethane balloon that can conform to the size and shape of the appendage. The pliable balloon, in place of the nitinol frame, should be easier and safer to implant – complex sizing requirements are reduced or eliminated, as is the risk of perforating the appendage during the implant procedure. The OccluNova device also has no exposed metal, which has proven to be a source of thrombin formation (stroke risk) in 2-3% of cases with existing LAAC technology, adding another layer of improved safety. Completely filling the opening of the appendage by inflating the pliable balloon is intended to eliminate further thrombus formation in the appendage and prevent existing thrombi from embolizing – improving safety of discontinuing OAC therapy for implanted AF patients.