• Arterial Remodeling Technologies (ART; Paris) disclosed new data related to its bioresorbable stent platform – additional data that it says further validates the company's innovative approach to simultaneously balance biocompatibility, biomechanics and bioresorption within a bioresorbable PLA (polylactic acid) stent. The new data show that the ART stent scaffold can be overinflated by more than 25% without cracking or crazing, and is thus designed to avoid the serious problem of malapposition associated with other bioresorbable stents that was documented at TCT 2010. ART claims its stent is designed to have several competitive benefits over existing bioresorbable stents in development: (1) faster and smoother resorption; (2) a non-crystalline polymer; (3) superior preserved material, without harmful by-products; (4) better, homogeneous stress diffusion; and (5) crack- and crazing-free expansion. In addition, the ART device is designed to be delivered by conventional stenting techniques, is balloon-expandable and meets the market standard of 6-French compatibility.
• Boston Scientific (Natick, Massachusetts) welcomed the publication of an analysis from its ALTITUDE Clinical Science program in the current issue of Circulation that showed patients followed by the Latitude Patient Management system experienced a 50% relative reduction in the risk of death compared to patients followed in-clinic only. The analysis also showed that heart failure patients who transmitted weight and blood pressure data via the Latitude system experienced an additional 10%reduction in the risk of death compared to other CRT-D patients followed by the Latitude system.
• Lantheus Medical Imaging (N. Billerica, Massachusetts) reported the first commercial production of TechneLite (Technetium Tc99m Generator) generators using molybdenum-99 (Mo-99) produced with low-enriched uranium (LEU) targets, making Lantheus the first company to use Mo-99 sourced from LEU in the U.S. Mo-99 is the parent isotope of technetium-99m (Tc-99m), the most widely used radioisotope in the world for molecular and nuclear diagnostic imaging tests. Tc-99m is a critical component of many medical tests, including scans of the heart, brain, kidneys and some types of tumors. Tc-99m is used in Lantheus Medical Imaging's TechneLite generators, which are distributed to hospitals and radiopharmacies as a source of Tc-99m for diagnostic imaging procedures.
• Orthovita (Malvern, Pennsylvania) received FDA clearance to market Vitoss Bioactive Foam-2X Bone Graft Substitute for use as a non-structural bone void filler for use in the spine, pelvis and extremities. As compared to Orthovita's current Vitoss Bioactive Foam Bone Graft Substitute products, the Vitoss Bioactive Foam-2X product has the same structure and porosity but contains increased levels of bioactive glass, which in-vitro testing has shown induces two times the deposition of calcium phosphate growth onto the surface of the implant, while retaining the same handling properties. Vitoss Bioactive Foam-2X contains Orthovita's proprietary Vitoss beta-tricalcium phosphate bone graft substitute scaffold and Kensey Nash's proprietary collagen material.
• Quest Diagnostics (Madison, New Jersey) was granted FDA approval for the Focus Diagnostics Simplexa Flu A/B & RSV test on the 3M Integrated Cycler. The Simplexa test is intended as an aid in the detection and discrimination of influenza A, influenza B and RSV virus infections. It is the first molecular test cleared by the FDA for detecting flu viruses and RSV that does not require confirmation of test results by other time-consuming methods, such as culture. The Simplexa tests employ real-time reverse transcription (RT) polymerase chain reaction (PCR) to qualitatively detect RNA of the influenza A or B viruses or RSV in a patient's nasal or nasopharyngeal specimens. The Simplexa Flu A/B & RSV test reports if a patient is positive or negative for infection with one or more of the three classes of viruses.