New FDA Approvals
FDA recently announced these approvals:
• Grifols Biologicals' antihemophilic factor/von Willebrand factor complex (human), Alphanate, indicated for patients undergoing surgery or invasive procedures with von Willebrand disease in which the hormone desmopressin is either ineffective or contraindicated. FDA said the product is not approved for patients with severe von Willebrand disease (Type 3) who are undergoing major surgery. The disease is the most common inherited bleeding disorder, affecting some 1% of the U.S. population.
FDA says Alphanate is the first biologic approved for treating surgical and invasive procedures in patients with von Willebrand disease. It previously was approved for preventing and controlling bleeding in patients with Factor VIII deficiency due to hemophilia A or acquired Factor VIII deficiency.
Alphanate is purified from pooled human plasma from screened and tested U.S. donors, and contains the clotting proteins deficient or defective in von Willebrand disease, which are Factor VIII (also known as antihemophilic factor. Alphanate undergoes two separate steps for viral inactivation to reduce the risk of transfusion-transmitted viruses.
• Agendia's MammaPrint test that determines the likelihood of breast cancer returning within five to 10 years after a woman's initial cancer has been cleared for marketing by FDA. The agency said the test uses the latest in molecular technology to predict whether existing cancer will metastasize. The test relies on microarray analysis, a powerful tool for simultaneously studying the behavioral patterns of large numbers of genes in biological specimens, FDA said.
Agendia, based in Amsterdam, Netherlands, reportedly compared the genetic profiles of a large number of women suffering from breast cancer and identified a set of 70 genes whose activity confers information about the likelihood of tumor recurrence. The MammaPrint test measures the activity level of each of these genes in a sample of a woman's surgically removed breast cancer tumor and then uses a specific algorithm to produce a score determining whether the patient is deemed low risk or high risk for the cancer to spread. FDA said test results may help doctors plan appropriate follow-up for a patient when used with other clinical information and laboratory tests.
MammaPrint is the first cleared in vitro diagnostic multivariate index assay device. Several months ago FDA issued a draft guidance concerning need for these complex molecular tests to meet pre-market review and post-market device requirements even when the tests are developed and used by a single laboratory.
• Vascutek's Temporary Limb Salvage Shunt, a medical device that can save the arms and legs of soldiers critically injured in combat as well as individuals in other trauma settings and emergency situations was cleared for U.S. marketing. FDA reviewed the device in less than one week because of the critical need for such a device. Officials said the device works by connecting together the ends of a severed blood vessel, providing a bridge or shunt around the damaged area and restoring blood flow to the injured limb.
The Temporary Limb Salvage Shunt is a tube formed of two layers of plastic. Features that optimize its use in trauma situations include a self-sealing elastomer membrane that permits drugs to be injected directly into the shunt without loss of blood, beveled ends that facilitate quick and effective device placement within a severed blood vessel, graduated markings that provide visual confirmation of proper device placement, and extra reinforcement in the center of the device so it can be cut to a shorter length if needed.
FDA recently announced these approvals: Grifols Biologicals' antihemophilic factor/von Willebrand factor complex (human), Alphanate, indicated for patients undergoing surgery or invasive procedures with von Willebrand disease in which the hormone desmopressin is either ineffective or contraindicated.Subscribe Now for Access
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