CORPUS CHRISTI, Texas, Sep 02, 2008 (BUSINESS WIRE) -- CSMG Technologies, a technology management company, announced its subsidiary, Live Tissue Connect Technologies (LTC), has been awarded CE Mark (ConformitA(C) EuropeA(C)ne) certification for its Bipolar Forceps by BSI Product Services in its capacity as Notified Body for the Council Directive 93/42/EEC.The CE Mark allows LTC to market its forceps with the previously CE Mark certified VAD.400 generator within the 30 countries of the European Economic Area (EEA) and Switzerland. This announcement follows LTC Technologies previously announced 510(k) clearance from the FDA to market both the aforementioned generator and forceps in the United States.
Obtaining CE Mark certification is an extensive process that requires evaluation of the device by the Notified Body to ensure compliance with EU directives and standards. To become certified, a company must have an established quality system and must submit a technical file providing evidence of compliance that the product meets applicable directives and standards.
The LTC Bipolar Forceps consist of two configurations of disposable instruments and are used exclusively with the LTC VAD.400 generator. Its intended use is for the application of electrosurgery in general surgery and gynecological procedures for the sealing of arteries, veins, and ducts. The Bipolar Forceps system is an alternative to mechanical clamping (clips or staples) and suturing, and can be used on veins and arteries up to 7mm diameter, on ducts up to 2mm diameter and on tissue bundles as large as will fit between the jaws of the instrument.
Donald S. Robbins, President and CEO of CSMG Technologies, said, "I am very pleased to announce LTC has received this CE Mark certificate. Combined with their FDA 510(k) clearance, LTC may now begin the process of marketing their sealing system in both Europe and the United States. I want to congratulate the LTC Technologies division, headquartered in Santa Barbara, whose efforts succeeded in securing this very important certification."Frank D. D'Amelio, President of LTC Technologies added, "We have set forth an aggressive schedule for commercialization of LTC's technology and we continue to execute against that plan as evidenced by the receipt of this CE Mark certificate and our recent FDA 510(k) clearance. In addition, achieving this CE certification demonstrates our commitment to be a global organization with world-wide distribution. Our sales recruitment efforts are proceeding according to plan and potential dealers have expressed much enthusiasm for our technology and the opportunity to join the LTC sales team."
