P> • FzioMed (San Luis Obispo, California) reported the presentation of preclinical studies demonstrating Oxiplex Gel as an injectable drug delivery system for a novel, synthetic peptide bone growth factor. The poster presentation is being made at the 12th International Meeting on Advanced Spine Techniques held last week in Banff, Alberta, Canada. Oxiplex is a synthetic, bioabsorbable, injectable gel for the percutaneous delivery of therapeutics for use in a variety of surgical applications. The first study tested Oxiplex for its utility as a drug delivery system. The results demonstrated that Oxiplex loaded with the antibiotic ampicillin was easily injected into a site and did not impact the activity or diffusion of the ampicillin. The second study evaluated Oxiplex as a vehicle for the delivery of a novel peptide bone growth factor being developed by FzioMed. The study compared healing in a bone defect filled with Oxiplex containing the growth factor to controls where the defect was filled with either Oxiplex alone or left unfilled. The results showed that Oxiplex alone had a positive stimulatory effect on bone healing. However, when Oxiplex was combined with the bone growth factor, there was an additional acceleration of bone healing.

• Medtronic (Minneapolis) reported the U.S. introduction of the EnTrust implantable cardioverter defibrillator (ICD). The company said the EnTrust single- and dual-chamber devices expand its premium line of ICDs, which are designed to treat patients with ventricular tachycardia (VT) that can lead to sudden cardiac arrest. The EnTrust ICD family was approved by the FDA on June 14. EnTrust is the first ICD to offer ATP During Charging, a Medtronic-exclusive feature that automatically uses pacing pulses to painlessly stop fast, dangerous heartbeats, while concurrently preparing to deliver a shock if needed. The company said recent clinical studies have shown that 90% of fast heart rhythms have the potential to be terminated by pacing alone. It said the use of this anti-tachycardia pacing to stop fast heartbeats has been clinically proven to eliminate three out of four shocks with painless therapy, potentially improving patient quality of life. The EnTrust dual-chamber ICD also helps reduce inappropriate therapy by better identifying episodes of supraventricular tachycardia, which may ensure that patients receive appropriate shocks. The dual-chamber version also incorporates a pacing mode called Managed Ventricular Pacing (MVP), which promotes natural heart activity by “significantly reducing” unnecessary pacing in the heart’s ventricle. This algorithm can reduce the amount of ventricular pacing to a median of 0.1%, compared to 50% or more with typical dual-chamber ICDs, Medtronic said. MVP has been available in several Medtronic pacemakers and defibrillators since 2004.

• Power3 Medical Products (The Woodlands, Texas) said the U.S. Patent and Trademark Office has issued patent No. 6,855,554, for which the company has a non-exclusive license from the University of Texas M. D. Anderson Cancer Center. The patent covers the method of discovering and detecting breast cancer through the identification of protein markers or a pattern of protein markers obtained from the application of proteomics to breast nipple aspirate fluid from women being tested for breast cancer. A second patent application, filed jointly by M. D. Anderson and the company, covering the proteomic techniques used in Power3’s NAFTest, is the subject of an exclusive license the company has with M. D. Anderson, and is currently pending. The NAFTest (Nipple Aspirate Fluid Test) involves generating a pattern of proteins in a sample using 2-D gel electrophoresis to identify differences between cancerous and non-cancerous samples from the same patient.

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