Livac Pty Ltd, an Australian medical device company, after having completed all necessary regulatory requirements of the US Food and Drug Administration, can now proceed with supply of their organ retraction system “the LiVac™ Retractor System” in the US market.
Livac Pty Ltd CEO Dr. Anabela Correia said “The completion of all FDA regulatory requirements signals a major milestone for the company and underpins the expansion of our lead product, the LiVac™ Retractor System, into the highly-valued US market. We will continue to build on our partnerships in the US and globally with key players in the surgical space.”
Developed in Melbourne by surgeon Dr Philip Gan, the LiVac™ Retractor System includes a soft and flexible silicon ring used in laparoscopic procedures (or keyhole surgery) to gently retract the liver or spleen, which is frequently necessary to provide a clear visual field for surgeons to access target organs.
Unlike other surgical retractors which can consist of a large metal “hook”, LiVac™ uses suction to provide gentle organ retraction and does not require a separate surgical incision for insertion and placement.
“Minimising tissue trauma is a major component of Enhanced Recovery After Surgery (ERAS). The LiVac™ Retractor reduces the number or size of incisions in a wide range of operations, is gentle in its mechanism of action, and to date has never had a reported Device Related Adverse Event.” Dr Gan commented.
“We conducted a retrospective Clinical Study over three years and found that those patients who had their gallbladders removed through three incisions instead of four, had less narcotic analgesia requirements and a shorter length of stay, including many who were happy to go home the same day. The LiVac™ Retractor had been used in virtually all the three-incision technique patients. Furthermore, these patients had less scarring and great satisfaction. All the hospitals I have worked at have been greatly supportive of these techniques.”
LiVac™ is currently being used by key surgeons in hospitals across Australia, Asia and Europe. More recently, it was successfully trialled in a robotic surgical procedure.
Dr. Correia said “The next major milestone for us is US market entry. The FDA Establishment Registration will enable Livac to continue to make in-roads to support clinical use, sales and distribution of LiVac™ in the US market. Discussions are already underway with selected US surgeons and hospital groups interested in clinical evaluation of our innovative product.”
As the company continues to focus on delivering its strategic business objectives and entry into major markets, it has already identified and begun development of additional Patented products to add to its pipeline.