The German Institute for the Hospital Remuneration System (InEK) has renewed Status 1—the highest of four levels—for SentreHEART’s Lariat and Eclipse left atrial appendage closure devices across 50 hospitals under the NUB innovation programme.
This decision allows approved hospitals in Germany to negotiate reimbursement to cover costs for treating patients where left atrial appendage closure with the Lariat may be a suitable alternative to anticoagulation. A NUB decision is valid for one year and can be renewed by application.
In Europe, the Lariat is used clinically as a non-implant solution to left atrial appendage closure. Studies have demonstrated the Lariat not only closes the left atrial appendage mechanically but may also isolate electrical activity within the left atrial appendage. Having a non-implant option that may both electrically and mechanically isolate the left atrial appendage is a potentially important addition to the treatment armamentarium for clinicians treating patients with persistent or longstanding persistent atrial fibrillation. According to a company release, the Lariat has the potential to eliminate the left atrial appendage as a source of atrial fibrillation and nidus for thrombus. The Lariat is presently being studied in the US Food and Drug Administration Investigational Device Exemption-approved, prospective, multi-centre, randomised and controlled AMAZE trial.