Closure Medical Corporation has received US FDA (Food and Drug Administration) approval to initiate a pivotal clinical study to support U.S. Premarket Approval for its vascular sealant product, the Company's first product to be used inside the body. The approval was based on the positive results of a ten-patient pilot study that completed enrolment last December.
The randomised pivotal study will utilise 150 patients, who will be monitored at the four- and twelve-week periods. The study will use approximately 14 medical institutions in the United States and Europe. Dr. Alan B. Lumsden of Baylor College of Medicine and the Methodist DeBakey Heart Center, The Methodist Hospital, Houston, Texas will act as the principal investigator of the study.
The study aims to assess the ability of Closure’s vascular sealant to prevent leakage following reconstruction of vascular structures in patients receiving femoral-popliteal bypass or arteriovenous access grafting.
Receiving FDA approval to run the clinical study is an achievement in itself for the company, which intend to enrol their first patient over the next few weeks. They intend to have completed the study by the end of 2004.
Pending a successful study, and approval of the European CE Mark, Closure hope to start commercialisation of their product in 2005.
Closure’s vascular sealant is intended to be used in vascular procedures such as reconstructive grafts and dialysis-access procedures. The product is biodegradable and designed to seal the surfaces of veins, arteries and artificial grafts that can leak after suturing. 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 transparent, allowing physicians to determine that the seal at the surgical site is complete.