TAKOMA PARK, Md.--(BUSINESS WIRE)--A surgical team at Rush University Medical Center in Chicago, Ill., with coordination by US Medical Innovations, LLC (USMI) successfully used the Canady HeliosTM Cold Plasma Scalpel (CHCPS) for the selective killing of cancerous tissue during a two-stage liver resection for advanced inoperable liver cancer.
After a one-time pre-market Humanitarian Compassionate-Use Exemption from the Food and Drug Administration (FDA), this groundbreaking surgery was performed on January 16, 2017 on a 40-year-old woman with inoperable Stage IV Intra-hepatic cholangiocarcinoma. The patient was first diagnosed in January 2016.
The surgery was the first of its kind in the world using USMI’s Canady Hybrid Plasma Scalpel (FDA cleared) to remove the tumor and then using the Canady Helios Cold Plasma Scalpel, a new technology that is designed to target cancer cells while sparing normal cells and tissue. The complex surgery was performed by surgeon Keith Millikan, M.D., at Rush University Medical Center.
The surgery entailed removing 85% of the patient’s liver in two stages, while the remaining cancer-free 15% was spared by the procedure so that it could regenerate. The innovative technology allowed the surgical removal of the cancerous tissue without damaging the blood supply to the remaining liver.
The patient’s second stage liver resection was performed on March 10, 2017. She is doing well three months after her second stage liver resection. Her liver has regenerated, and there is currently no evidence of tumor based on her tumor markers, pathology, postoperative CT scans and translational/molecular findings. The patient will return to her home in South Africa in early June.
USMI CEO, Chief Science Officer and surgeon, Jerome Canady, M.D., who designed the clinical and treatment protocols, was the first to perform the two-staged hepatectomy procedure for intrahepatic cholangiocarcinoma 10 years ago. He is co-inventor of the Cold Plasma Helios device along with Michael Keidar, Ph.D. Professor in the Department of Mechanical and Aerospace Engineering at the George Washington University, Washington, D.C.
The patient’s preoperative treatments included chemo and radiation therapies to shrink the tumor. Three-dimensional CT-scan computer-guided imagery was used to map out the surgery. A multidisciplinary group of healthcare professionals, physicians, research scientists, and engineers from U.S., South Africa and Israel collaborated to achieve this successful outcome.
The surgery and the use of CHCPS was cleared by the Food and Drug Administration as an emergency measure after receipt of the application and request from US Medical Innovations, LLC and Canady Biotechnology, LLC (CB), manufacturer of USMI surgical products. The devices used in the procedure were designed by CB’s sister company Plasma Medicine Life Sciences, LLC, while the translational and molecular protocols were developed by the Jerome Canady Research Institute for Advanced Biological and Technological Sciences, Benefit LLC, an affiliated research organization.
As the CHCPS has not yet been cleared by the FDA for commercial use or marketing, USMI and its sister companies will coordinate on the submission for a US multi-center clinical trial of an FDA Investigational Device Exemption (IDE) application for such authorization during the coming months.
About US Medical Innovations, LLC
US Medical Innovations, LLC (USMI) is a private U.S. biomedical device company and wholly-owned subsidiary of US Patent Innovations, LLC. USMI’s focus is developing advanced innovative affordable plasma and robotic electrosurgical devices and striving to develop innovative devices in the field of plasma technology for the eradication of cancer.