Public HealthInnovia Receives FDA Clearance For The InnoPort(TM)
Innovia LLC, a privately held biomaterials-based medical device company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the InnoPort(TM) to facilitate single port access laparoscopy.
The InnoPort is inserted into the abdomen to perform laparoscopic surgery through one small incision--instead of multiple incisions--with the goal of minimizing scarring, pain, recovery time, and complication risk to the patient. The port is enabled by Quatromer(R), one of Innovia"s proprietary biopolymers. The biopolymer"s patented flexibility grants the physician unrestricted access to the abdominal cavity with up to three rigid and/or articulating instruments.
"In the time-sensitive and no-nonsense environment of the OR, the bell-and-whistle features of existing ports were overly complicated and tended to slow down my procedures. I needed a port that was simple and reliable, and this was the inspiration for the InnoPort," said David Edelman, MD, General Surgeon and inventor of the device. "Compared to other available single access ports, the InnoPort seems to be the easiest to use. The one-piece, stopper-shaped device can be inserted quickly, and its flexibility allows me to manipulate my instruments to extreme angulations without crowding one another in the working space, all while maintaining a tight insufflation seal."
"Our staff is especially proud to have worked with Dr. Edelman to develop the InnoPort," adds Len Pinchuk, Ph.D., D.Sc., President/CEO of Innovia. "We believe that the device will fulfill unmet clinical needs for simplicity and efficacy in the rapidly expanding single incision laparoscopic space and are confident that physicians will agree."
The InnoPort is scheduled for commercialization in the United States this year with expansion to Europe thereafter. For further information, please contact Innovia.
ABOUT INNOVIA LLC
Innovia is a privately held biomaterials-based medical device company that specializes in the development of innovative medical devices incorporating proprietary novel biomaterials. Innovia"s experienced and highly specialized engineers, scientists, and chemists have been responsible for over $15 billion in revenue throughout their careers in the medical device industry.
Innovia LLC