Release date: 2018-03-13
Polyganics, a medical technology company that develops bioabsorbable medical devices, recently announced that the FDA has issued Breakthrough Device designation for Polyganics' liver and pancreas seals. Liver and pancreas seals are considered a unique breakthrough in preventing fluid leakage after hepatic pancreaticobiliary (HPB) surgery and there are no approved alternatives.
Polyganics is a medical technology company with a variety of multi-purpose polymer platforms. Polyganics develops, manufactures and commercializes innovative bioabsorbable medical devices that promote tissue repair and regeneration. The company's product portfolio includes in-house development and collaboration with leading medical technology companies and academic centers to develop products. In the field of peripheral nerve repair (PNR) and neurosurgery, the product portfolio includes three marketed products: VIVOSORB for reducing postoperative tissue adhesion; NEUROLAC for postoperative PNR support; NEUROCAP for symptomatic neuroma . Products under development include dura mater seals and liver seal patches.
The liver and pancreas sealant is made of Polyganics' proprietary bioabsorbable and biosafety polymer that seals the surgically treated tissue during critical healing. The polymer formulation of the liver and pancreas sealant is optimized for HPB surgery and can withstand the effects of invasive bile and pancreatic juice. It is designed to prevent fluid from infiltrating into the abdominal cavity at the surgical site after HPB surgery and as an auxiliary hemostasis device to control mild to moderate bleeding.
The FDA will support products that have achieved breakthrough device identification and push for development and marketing decisions for liver and pancreas sealants. The FDA will also work closely to effectively and flexibly design clinical trials, as well as collect pre-sales and post-sales data. This support and priority review is expected to shorten the regulatory timeframe.
Dr. Jakob Izbicki, chief surgeon of the Eppendorf University Medical Center (UKE) and development partner of Polyganics Liver and Pancreas Sealing Patch, commented: "There is a clear need for a device that can effectively control fluid leakage during HPB surgery. It is easy to use and can be sealed to withstand the action of enzymes and acids such as bile and pancreatic juice. If effective closure of the postoperative tissue is achieved, hospitalization time and postoperative complications such as infection, abdominal abscess and sepsis will be reduced. This has a positive impact on the patient's postoperative quality of life."
â–² Mr. Rudy Mareel, CEO of Polyganics (Source: Polyganics Official Website)
Mr. Rudy Mareel, CEO of Polyganics, commented: “We are pleased that FDA has decided to issue a breakthrough device certification for our liver and pancreas seals. This is a good recognition that the device may have potential clinical benefits for patients. We look forward to working with the FDA to bring this product to market faster, resulting in better results for patients with surgery."
We expect this patch to be available soon, reducing pain for patients after surgery and bringing recovery as soon as possible.
Reference materials:
[1] FDA Grants Breakthrough Device Designation to Polyganics' Liver and Pancreas Sealant Patch
[2] Polyganics official website
Source: WuXi PharmaTech
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