OccluNova is developing an implantable device for people with chronic atrial fibrillation (AF).

Blood, in patients with chronic AF, pools in a small chamber in the left atrium – the left atrial appendage – and thrombus forms. These patients are at increased risk for ischemic stroke, as these thrombi can enter the bloodstream and lodge in the vasculature of the brain.

As a result, the patients are indicated for life-long oral anti-coagulation (OAC) therapy. OAC therapy is associated with many side effects, including major gastro-intestinal or cranial bleeding, and sometimes requires significant life-style modifications. Activities that carry a risk of injury need to be avoided, because OAC therapy will not allow wounds to stop bleeding.

The OccluNova device is designed to occlude the atrial appendage, preventing new thrombus formation and allowing patients to terminate OAC without increased risk of stroke.
There are currently more than 3 million people in the US and 4.5 million people in Europe with chronic atrial fibrillation (AF).

As of 2017, it was estimated that there were 37,574 million cases of AF in the world, increasing 33% over the past 20 years. It is estimated that, by 2030, more than 12 million people in the US alone will have AF.

In addition to European ancestry, some of the primary risk factors for AF include: advancing age, high blood pressure, obesity, and diabetes – all of which are steadily increasing in developed countries across the globe, particularly in the US.

OccluNova is committed to providing a next-generation alternative to lifelong oral anticoagulation (OAC) therapy for all of these patients. By occluding the left atrial appendage, patients with chronic AF can live a fuller life, without increased risk of ischemic stroke, by terminating OAC and avoiding the many side effects and lifestyle limitations associated with it. Current left atrial appendage closure (LAAC) devices have shown roughly equivalent stroke rates among implanted patients and terminating OAC compared with patients remaining on OAC. However, improvements over existing technology have been identified that could make LAAC an even more effective option for a greater number of people suffering from AF. OccluNova is developing technology that is intended to directly address the limitations of existing technology – allowing a greater number of people realize the fuller life that safely terminating OAC therapy can provide.
Incomplete occlusion, implant procedure complications, and thrombus formation on exposed metal are the primary concerns associated with existing commercial LAAC technology.

The OccluNova technology is designed to more completely occlude the appendage by utilizing a pliable balloon to completely fill the entrance of the appendage. Incomplete occlusion sometimes requires continuation of oral anticoagulation (OAC) therapy or exposes the patient to a higher risk of ischemic stroke despite having the implant.

The existing LAAC technologies are all constructed of a rigid nitinol frame, which can easily be forced through the atrial wall during placement, causing potentially serious pericardial effusions. The rigid nitinol frame also makes proper sizing, which is crucial in achieving complete occlusion, difficult. OccluNova’s technology eliminates the rigid nitinol frame and instead is made from a pliable polyurethane balloon. These features should make proper sizing, complete occlusion, and the implant procedure itself easier. Finally, there is no exposed metal on the OccluNova implant, reducing or eliminating the risk of device-related thrombus formation. We aim to deliver a safer and more effective LAAC implant that more reliably occludes the appendage and allows more patients to safely terminate oral anti-coagulation therapy.

News from OccluNova