REDWOOD CITY, Calif.--(BUSINESS WIRE)--SentreHEART, Inc., developer and manufacturer of the percutaneous LARIAT® Suture Delivery Device (LARIAT) and ECLIPSE™ Surgical Left Atrial Appendage Closure (LAAC) Device, announced that the German Institute for the Hospital Remuneration System (InEK) has renewed Status 1, the highest of 4 levels, for the LARIAT and ECLIPSE LAAC devices across 50 hospitals under the NUB1 innovation program. 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.
“We are very pleased with the NUB renewal and the robust number of applications for 2017. This is validation of the growing interest by German clinicians utilizing the LARIAT as a non-implant solution for LAA closure,” said Russ Seiber, President and CEO of SentreHEART, Inc.
In Europe, the LARIAT is clinically utilized as a non-implant solution to LAA closure. Studies have demonstrated the LARIAT not only closes the LAA mechanically2 but may also isolate electrical activity within the LAA3. Having a non-implant option that may both electrically and mechanically isolate the LAA is a potentially important addition to the treatment armamentarium for clinicians treating patients with persistent or longstanding persistent AFib. The LARIAT has the potential to eliminate the LAA as a source of AFib and nidus for thrombus. The LARIAT is presently being studied in the FDA IDE-approved, prospective, multi-center, randomized controlled aMAZE Trial (www.amazetrial.com; clinicaltrials.gov identifier NCT02513797).
About SentreHEART, Inc.
SentreHEART is a privately owned medical device company based in Redwood City, CA. Founded in 2005, SentreHEART has developed innovative technology for remote delivery of suture for closure of anatomic structures including the left atrial appendage. SentreHEART is the only company that offers both percutaneous and surgical options for immediate and complete LAA closure without the need for an implant.
1 Neue Untersuchungs und Behandlungsmethoden (NUB)
2 Bartus K, et al. Percutaneous Left Atrial Appendage Suture Ligation Using the LARIAT Device in Patients with Atrial Fibrillation. J Am Coll Cardiol 2013 Jul 9;62(2):108-18
3 Han FT, et al. The Effects of LAA Ligation on Electrical Activity. Heart Rhythm. 2014 May; 11(5):864-70