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news.Kinetic Concepts, a medical technology company, has announced that its subsidiary LifeCell has received CE Mark approval from the Netherlands-based notified body, KEMA, for its Strattice reconstructive tissue matrix.
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The CE Mark allows Kinetic Concepts (KCI) to begin marketing Strattice in all 27 member states. Strattice has previously received 510(k) clearance from the FDA and has been available commercially in the US since February 2008.
Strattice is available immediately for surgeons in select EU markets with the full commercial launch of LifeCell’s new reconstructive tissue matrix anticipated in the first half of 2009.
Strattice is a porcine-based, acellular dermal matrix that acts as a scaffold that is revascularized and repopulated by the host, ultimately converting the matrix into functional, living tissue. The product is recommended for use in a range of applications involving tissue repair to reinforce soft tissue where weakness exists, such as challenging hernia repair and breast reconstruction.
Catherine Burzik, president and CEO of KCI, said: “Strattice’s availability within the EU will allow further expansion of our regenerative medicine business and demonstrates KCI’s commitment to developing innovative therapies that address unmet medical needs of clinicians and their patients around the world.”