NuOrtho Surgical Receives FDA 510(k) Clearance

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Fall River, MA, July 6, 2010, NuOrtho Surgical, Inc., a developer of leading edge surgical instruments, received 510(k) clearance from the Food and Drug Administration clearance to market its Ceruleau™ surgical probe in the United States.

(PRWEB) July 14, 2010 — Ceruleau™, is a 3.5 mm arthroscopic radio frequency (RF) electrosurgical probe made for the treatment of soft tissues, particularly fibrillated articular cartilage. This novel electrosurgical device is designed to aid the surgeon by selectively targeting diseased cartilage tissue during procedures intent to restore smooth chondral surfaces. Studies have demonstrated that its design, which combines low RF energy delivery with a protected electrode (to avoid electrode-to-tissue contact), allows for localized treatment of damaged/fibrillated cartilage tissue while avoiding harm to healthy cartilage.

“This 510(k) clearance is an important step towards advancing our technology and the Tissue Preservation™ platform” said Jeff Morrill, CEO of NuOrtho Surgical. “We repeatedly hear that surgeons want to do everything they can to maximize the preservation of healthy tissue during surgical procedures. Ceruleau™ helps deliver this need for surgeons and patients. This is the first product of many we are developing in support of our Tissue Preservation™ platform”. Manufacturing of Ceruleau™ is underway and NuOrtho Surgical is finalizing launch plans for the new product. NuOrtho has signed agreements with a number of leading medical device distributors around the country to help build rapid market penetration. NuOrtho Surgical Inc., is currently focused on the design and manufacture of surgical devices that enable Tissue Preservation™ to improve patient outcomes in the orthopedic arena. NuOrtho has three primary product platforms for preserving healthy tissue to sustain long-term mobility. These platforms include Soft Tissue Treatment, Agent Delivery and Bone Fusion, however to date only the Ceruleau™, product has been cleared to market. In addition to the patents held for Ceruleau™, the company has numerous other patents, providing significant business opportunities. Learn more at     http://www.nuorthosurgical.com/

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Source : PRWeb

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