ArtiSential devices features patented double-jointed end effector, enabling surgeons to handle difficult angles of approach in complex procedures.
The FDA Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia.)
South Korea-based medical device company LivsMed has received the US Food and Drug Administration (FDA) 510(k) for its new ArtiSential Bipolar Maryland Dissectors.
The company said that the US regulatory approval completes its energy product line, which also includes the Bipolar Fenestrated Forceps, Monopolar Hook and Monopolar Spatula.
LivsMed introduced the ArtiSential product line to the Korean medical device market in 2018 and expanded into the US in 2019.
LivsMed founder and CEO Jung Joo Lee said: “We are excited that Dr. Dunning has been a great spokesperson for ArtiSential. Now, with more surgeons in the US experiencing ArtiSential, we are on our way to fulfill our mission of ‘bringing precision surgery into the hands of surgeons, one patient at a time.
“There has been a tremendous amount of interest from surgeons in South Korea where we first launched the product in 2018. Today, we now have a surgeon who has completed over 1000 cases using ArtiSential devices who says that he ‘can’t go back to using straight instruments’. We plan to continue to innovate and support the US market, which is largest in the world.”
ArtiSential laparoscopic instruments feature advanced effector and ergonomic grip
ArtiSential laparoscopic instruments feature a double-jointed end effector and an ergonomic grip to facilitate wristed movements and provide 7 degrees of freedom.
The advanced capabilities are incorporated into a low cost, fully mechanical instrument, enabling surgeons to tap on the advantages of robotic platforms and simultaneously providing tactile feedback, which robotic systems lack.
ArtiSential devices are designed for use with any 8mm, or larger sized trocar, and can be immediately incorporated into any surgical setting without needing additional capital equipment in operating room.
The energy instruments join the company’s existing product line that includes the Needle Holder, Clip Applier, non-energy Fenestrated Forceps and Maryland Dissector.
LivsMed USA president Karl Im said: “We are pleased to offer a full suite of wristed Instruments, which has only been afforded via robotics until now.
“ArtiSential is gaining interest with institutions and surgeons alike, who are looking for alternative options to a robotic procedure. We have essentially revolutionized traditional laparoscopy by introducing the dexterity of a robotic system to a laparoscopic instrument without the loss of tactile feedback.”