Advertisement

October 2, 2016

SentreHeart Closes $35 Million Funding Round for aMAZE Trial

October 3, 2016—SentreHeart, Inc., the manufacturer of the Lariat technology for catheter-based, nonimplant left atrial appendage closure (LAAC), recently announced that it has closed a $35 million Series D round of financing. The funding will be used to complete the aMAZE randomized, pivotal clinical trial evaluating the use of the Lariat device for LAAC as an adjunctive treatment to ablation in patients with persistent or longstanding persistent atrial fibrillation (AF).

The financing was led by Deerfield Management Company, with participation from U.S. Venture Partners, Prospect Ventures, Vivo Capital, and Decheng Capital. Deerfield Partner Ted Huber will join SentreHeart’s Board of Directors.

According to the company, the objective of the aMAZE trial is to demonstrate that use of the Lariat device for LAAC plus pulmonary vein isolation (PVI) ablation will lead to a reduced incidence of recurrent AF compared to PVI alone, with a high safety profile. SentreHeart noted that recent studies have demonstrated that the Lariat device not only closes the LAA mechanically, but can also isolate electrical activity within the LAA, which is a known contributor to AF.

SentreHeart advised that the Lariat suture delivery device is indicated for suture placement and knot tying in surgical procedures where soft tissues are being approximated and/or ligated with a pretied polyester suture. The company received US Food and Drug Administration 510(k) clearances for the Lariat device in 2006, 2009, and 2014. The device also has received CE Mark approval in Europe.

Advertisement


October 3, 2016

SCAI Responds to CMS Regarding Proposed AMI Bundles

October 3, 2016

SCAI Responds to CMS Regarding Proposed AMI Bundles


)