CSMG Technologies, Inc., (OTCBB: CTGI), a technology management company, announced its subsidiary Live Tissue Connect, Inc. (LTC) received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its LTC VAD System. The LTC VAD System consists of a LTC VAD.400 bipolar electrosurgical generator and two disposable sealing instruments. FDA clearance allows LTC to market these products in the USA.
The VAD.400 generator and the two disposable instruments are intended for use in open general surgical and gynecological procedures for the ligation of vessels and ducts as an alternative to mechanical clamping (clips or staples) and suturing. LTC’s new third generation bipolar system can be used on vessels (veins and arteries) up to 7 mm diameter, on ducts up to 2 mm diameter and tissue bundles as large as will fit in the jaw electrodes of the instruments.
Donald S. Robbins, President and CEO of CSMG Technologies, said, "I am very pleased for our shareholders to be able to announce the most important and long awaited event in the history of LTC. By LTC receiving its first U.S. FDA 510(k) on the generator and the two instruments they are now able to start marketing in the U.S. market. I wish to publicly congratulate all the medical device professions involved with the LTC technology and the LTC team in Santa Barbara, California. I also want to personally thank as well all the CSMG shareholders who have believed in our potential and stayed the course waiting for this key corporate event."
Frank D. D’Amelio, President of LTC said, “The 510(k) clearance of our generator and disposable instruments marks the completion of a major milestone for LTC. The technology embodied within the VAD.400 generator and the interconnecting disposable instruments represents years of scientific research regarding the effects of RF energy on tissue. The LTC bipolar system has undergone extensive animal clinical testing; has been the subject to numerous peer-reviewed papers; and has passed all applicable quality standards. Having now obtained this clearance, we will next implement our USA sales representative recruitment plan and ramp up our production for distribution.”
The VAD.400 generator and the two disposable instruments are intended for use in open general surgical and gynecological procedures for the ligation of vessels and ducts as an alternative to mechanical clamping (clips or staples) and suturing. LTC’s new third generation bipolar system can be used on vessels (veins and arteries) up to 7 mm diameter, on ducts up to 2 mm diameter and tissue bundles as large as will fit in the jaw electrodes of the instruments.
Donald S. Robbins, President and CEO of CSMG Technologies, said, "I am very pleased for our shareholders to be able to announce the most important and long awaited event in the history of LTC. By LTC receiving its first U.S. FDA 510(k) on the generator and the two instruments they are now able to start marketing in the U.S. market. I wish to publicly congratulate all the medical device professions involved with the LTC technology and the LTC team in Santa Barbara, California. I also want to personally thank as well all the CSMG shareholders who have believed in our potential and stayed the course waiting for this key corporate event."
Frank D. D’Amelio, President of LTC said, “The 510(k) clearance of our generator and disposable instruments marks the completion of a major milestone for LTC. The technology embodied within the VAD.400 generator and the interconnecting disposable instruments represents years of scientific research regarding the effects of RF energy on tissue. The LTC bipolar system has undergone extensive animal clinical testing; has been the subject to numerous peer-reviewed papers; and has passed all applicable quality standards. Having now obtained this clearance, we will next implement our USA sales representative recruitment plan and ramp up our production for distribution.”
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