Niki Arrowsmith05.02.13
Milford, Mass.-based PLC Systems Inc. has been awarded its first patent for its Renalguard product by the European Patent Office (patent number 2010268). The patent covers the core Renalguard device and its redundant infusion rate monitoring by which Renalguard infuses saline. The patent has a term extending to April 2027.
“Receiving this first European patent for Renalguard is a very important milestone for PLC,” said Andrew Halpert, director of marketing and engineering of PLC Medical Systems Inc. “This patent is an important step to help protect against infringement of our core technology in this important market. With this additional security, we have strengthened our presence in Europe, which is currently the largest market for commercial sale of the Renalguard system.”
Renalguard therapy is designed to rapidly remove contrast dyes that are potentially toxic to patients with impaired kidney function. Contrast dyes are used in many cardiovascular diagnostic and interventional imaging procedures to facilitate the capture and display of X-ray images. Approximately 10 to 20 percent of patients that undergo these procedures are at risk of developing contrast-induced nephropathy, a form of acute kidney injury resulting from toxic contrast dye. According to PLC, in two European investigator-sponsored clinical trials, Renalguard therapy reduced the incidence of acute renal failure in patients. PLC touts the therapy as having the capability to reduce morbidity and mortality, as well as hospital costs for the high-risk patients.
Renalguard is CE marked and is being marketed in Europe and selected countries around the world. The device is being studied in a pivotal trial in the United States as required for approval by U.S. Food and Drug Administration.
Halpert also said that the company was pursuing additional patent applications in Europe, the United States and Japan. “In addition to the positive results produced in the investigator-sponsored clinical trials of Renalguard in Europe, we are bringing new energy to our efforts to accelerate expanded distribution of Renalguard around the world,” he said.
PLC Systems is focused on cardiac and vascular technology.
“Receiving this first European patent for Renalguard is a very important milestone for PLC,” said Andrew Halpert, director of marketing and engineering of PLC Medical Systems Inc. “This patent is an important step to help protect against infringement of our core technology in this important market. With this additional security, we have strengthened our presence in Europe, which is currently the largest market for commercial sale of the Renalguard system.”
Renalguard therapy is designed to rapidly remove contrast dyes that are potentially toxic to patients with impaired kidney function. Contrast dyes are used in many cardiovascular diagnostic and interventional imaging procedures to facilitate the capture and display of X-ray images. Approximately 10 to 20 percent of patients that undergo these procedures are at risk of developing contrast-induced nephropathy, a form of acute kidney injury resulting from toxic contrast dye. According to PLC, in two European investigator-sponsored clinical trials, Renalguard therapy reduced the incidence of acute renal failure in patients. PLC touts the therapy as having the capability to reduce morbidity and mortality, as well as hospital costs for the high-risk patients.
Renalguard is CE marked and is being marketed in Europe and selected countries around the world. The device is being studied in a pivotal trial in the United States as required for approval by U.S. Food and Drug Administration.
Halpert also said that the company was pursuing additional patent applications in Europe, the United States and Japan. “In addition to the positive results produced in the investigator-sponsored clinical trials of Renalguard in Europe, we are bringing new energy to our efforts to accelerate expanded distribution of Renalguard around the world,” he said.
PLC Systems is focused on cardiac and vascular technology.