RALEIGH, N.C. -- Closure Medical Corporation, a global leader in biomaterial-based medical devices, announced the first use in humans of its synthetic vascular sealant product under the company's FDA-approved clinical trial. The first patient received the product at the University of Virginia Medical Center while undergoing an arteriovenous shunt procedure to insert an artificial graft for dialysis access. The current trial is a non-randomized, ten-patient pilot study with four- and twelve-week follow-ups.
The vascular sealant, the company's first product to be used inside the body, is designed to be biodegradable and is designed to seal the surfaces of veins, arteries and artificial grafts that can leak after suturing. In addition to dialysis access procedures, the product will also be used for other peripheral vascular procedures such as reconstructive grafts.
Daniel A. Pelak, president and CEO, commented, "The initiation of this study is a milestone for CLOSURE. Being able to treat indications inside the human body requires a much more advanced formulation, the development of which demonstrates the breadth of our core competence. Based on other research, we believe the vascular sealant is the first of multiple indications within the body that our technology may be used for."
The company believes its vascular sealant product offers advantages over other internal adhesives currently being used. The formulation is synthetic thereby eliminating the risk of infection transmission and immune response disorders associated with animal-derived or human blood-based products. In addition, the vascular sealant is transparent thus allowing physicians to be confident that the seal at the surgical site is complete.
Upon completion of the pilot study, the company anticipates the initiation of a pivotal study to support U.S. Premarket Approval and European CE Mark approval. Current plans are to enroll patients at multiple centers in the United States and Europe for treatment to be conducted in a hospital setting, with four- and twelve-week follow-up visits. The end-point of the study will assess the ability of Closure's vascular sealant to prevent leakage in the reconstruction of vascular structures.
Source: Closure Medical Corporation