US-based medical device firm SentreHEART has obtained CE mark approval for its Lariat surgical left atrial appendage (LAA) suture delivery device.
The new device allows surgeons to deliver a 50mm pre-tied suture loop through traditional open surgical procedures or through an access port as small as 5mm.
The 50mm snare features flexible shaft design for ease of use in delivery from different access locations.
The integrated suture-tightening system reduces the risk of operator variability during closure.
The device has been designed to be compatible with a range of surgical approaches for LAA or other soft tissue closure.
SentreHEART president and CEO Russell Seiber said: "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."
The common polyester suture of the device avoids interaction of metal with tissue and is compatible with open-chest, thoracotomy or port access procedures.
Under direct visualization, surgeon can lead the Lariat surgical snare loop over soft tissue, including the left atrial appendage, and deploy the pre-tied suture, for complete ligation without leaving any metal or clip behind.
In June, the US Food and Drug Adminsitartion (FDA) granted an investigational device exemption (IDE) approval to enroll patients in a clinical study of the Lariat suture delivery device.
The was designed to assess the use of the device for ligation, or closure, of the LAA as an adjunctive treatment to ablation in patients with persistent or longstanding persistent atrial fibrillation (AFib).
Image:Lariat surgical left atrial appendage suture delivery device. Photo: courtesy of Business Wire.