LivsMed Receives FDA 510(k) Clearance for ArtiSential™ Articulating Energy Laparoscopic Instruments
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SAN DIEGO, June 30, 2020 /PRNewswire/ -- LivsMed Inc. recently announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the new ArtiSential™ Bipolar Maryland Dissectors. This completes its energy product line, which also includes the Bipolar Fenestrated Forceps, Monopolar Hook and Monopolar Spatula. ArtiSential™ instruments feature a double-jointed end effector and an ergonomic grip that facilitates wristed movements to provide 7 degrees of freedom. These capabilities are incorporated into a low cost, fully mechanical instrument, enabling surgeons the same advantages as robotic platforms while also providing tactile feedback, which robotic systems lack. ArtiSential™ devices can be used with any 8mm, or larger, sized trocar, and can be immediately incorporated into any surgical setting without the need for additional capital equipment or large footprint in the operating room. "We are pleased to offer a full suite of wristed Instruments, which has only been afforded via robotics until now," says Karl Im, President of LivsMed USA Inc. "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," says Im. The ArtiSential™ energy instruments join LivsMed's existing product line that includes the Needle Holder, Clip Applier, non-energy Fenestrated Forceps and Maryland Dissector. These instruments are available in three different lengths (25cm, 38cm and 45cm) and optionally feature a locking mechanism that secures the articulating joints. Dr. Joel Dunning, a thoracic surgeon from the UK, summarizes by saying, "We want to mimic our hands in the body, and ArtiSential™ does this." "We are excited that Dr. Dunning has been a great spokesperson for ArtiSential™," says Dr. Jung Joo Lee, founder and CEO of LivsMed Inc. "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.'" Dr. Lee further states, "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." About LivsMed: LivsMed Inc. is a medical device company that brings groundbreaking technology to minimally invasive surgery. Founded in South Korea, LivsMed is the creation of Dr. Jung Joo Lee, who envisioned a new paradigm of laparoscopic surgery where articulating technology is available to every surgeon. With this vision, the ArtiSential™ product line was introduced to the Korean medical device market in 2018 and expanded into the US in 2019. Upon entering the US market, ArtiSential™ was immediately met with excitement from surgeons around the world, receiving the Red Dot Design Award and recognition from SAGES. Working with physicians worldwide, LivsMed focuses on revolutionizing the capabilities of minimally invasive surgery, advancing patient outcomes and extending life for patients around the world. For more information about LivsMed, visit www.livsmed.com.
SOURCE LivsMed |
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