Sentreheart Earns CE Mark for Cardiac Suture Device

Redwood City, Calif.-based Sentreheart Inc. has earned CE mark for the Lariat surgical left atrial appendage (LAA) suture delivery device. The product is aimed at soft tissue closure, including the LAA. European surgeons can now offer their patients precise, user-controlled delivery of a 50 mm pre-tied suture loop through traditional open surgical procedures.

The Lariat surgical LAA device complements the company’s soft tissue closure technology by leveraging the Lariat’s low profile delivery, designed to be compatible with a broad array of surgical approaches for LAA or other soft tissue closure. Features of the Lariat Surgical include a 50 mm snare that is compatible with access as small as 5 mm, a malleable shaft design for ease of use in delivery from different access locations, and an integrated suture-tightening system to reduce the risk of operator variability during closure.

The surgeon, while under direct visualization, can guide the Lariat Surgical snare loop over soft tissue, including the left atrial appendage, confirm its exact closure location, and deploy the pre-tied suture, resulting in immediate, complete ligation without leaving any metal or clip behind, the company reports.

“The Lariat surgical device solves many of the issues posed by current closure technologies in surgery. Improving the surgeon’s control, reducing operator variability and minimizing technique dependence through a simple to deliver, repeatable, suture-based solution is more natural for cardiac surgeons and should lead to better outcomes,” said Russell Seiber, president and CEO of Sentreheart.

Unlike current surgical closure solutions, including staplers and clips, the Lariat surgical LAA device uses a common polyester suture, which may prevent any metal-to-tissue interaction. Additionally, its low profile design will give surgeons greater control in suture placement location and is designed to be compatible with open- chest, thoracotomy or port access procedures.

“The Lariat surgical device is an elegant surgical closure solution, combining the best of all the current approaches into a single device,” offered Krzysztof Bartus, M.D., PhD, associate professor of cardiac surgery at Jagiellonian University Krakow, Poland. “The new device enables flexibility in my approach and access to close tissue where I want, with the additional confidence that it will remain closed. These are important characteristics when closing soft tissue such as the left atrial appendage.”