• Avanca Medical Devices (Albuquerque, New Mexico) reported FDA 510(k) clearance of its interventional specialty procedure syringes, the Procedur-10 and Procedur-SF. The Procedur family of syringes allows healthcare providers to inject and aspirate with one hand while maintaining needle stability. The syringes offer extensive applications in medical and surgical procedures using the company's reciprocal technology that allows injection and withdrawal of fluids or tissues simultaneously. Avanca said Procedur syringes reduce unnecessary injuries and save patients and hospitals money. The products will be introduced at the Society of Interventional Radiology Meeting in New Orleans this spring.

• Thoratec (Pleasanton, California) issued an update on its investigational device exemption application to the FDA to conduct a Phase II pivotal clinical trial for the HeartMate II, its next-generation left ventricular assist device designed to provide long-term cardiac support for patients who are in end-stage heart failure. The company said it is continuing to have discussions with the FDA regarding certain elements of the study's design. Based upon the nature of those items still under discussion, the company said it continues to have a high degree of confidence in a pivotal trial approval, which it hopes will occur in the next 15 to 45 days. Thoratec completed its Phase I study for the device in August 2004. It included 25 bridge-to-transplantation patients at 10 centers who have now accumulated about six years of total support.

• Xenogen (Alameda, California) reported that the U.S. Patent and Trademark Office has allowed claims in five patent applications that further protect its methods of real-time, non-invasive in vivo optical imaging (biophotonic imaging) of whole animals. Two of the allowed patent applications disclose non-invasive methods for detecting gene expression within a living mammal, where that mammal includes a gene encoding either a bioluminescent or fluorescent reporter protein linked to a selected promoter that drives its expression. The patent claims cover gene promoters that are always “on“ or promoters that can be switched on and off. The other three allowed patent applications disclose non-invasive methods for detecting eukaryotic cells or microorganisms in a living mammal, where the cells or micro-organisms have been transformed to incorporate either a bioluminescent or fluorescent reporter gene.