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Medical Devices / Submissions and Approvals

Tela Bio’s Reconstructive Bioscaffolds Cleared by FDA

April 22, 2019
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Tela Bio has received FDA’s 510(k) clearance for its Restella reconstructive bioscaffolds, devices used in plastic and reconstructive surgery.

The devices are designed to support the soft tissue of patients that require soft tissue repair or reinforcement in plastic and reconstructive procedures and are “engineered to allow for rapid tissue integration and revascularization and biomechanical control," Tela said.

The bioscaffolds use a patented “lockstitch” pattern and biologic material designed to minimize inflammation, reduce foreign body response and allow functional tissue remodeling.

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