• Abiomed (Danvers, Massachusetts) said that it has received conditional approval from the FDA to begin its Impella 2.5 circulatory support system study in the U.S. under an investigational device exemption for hemodynamically unstable patients undergoing a percutaneous coronary intervention (PCI) procedure due to acute myocardial infarction (AMI), or heart attack. The AMI shock study will determine the safety and effectiveness of the Impella 2.5 as a left ventricular assist device for heart attack patients as compared to optimal medical management with an Intra-Aortic Balloon Pump. There are estimated over 100,000 AMI anterior infarct patients annually in the U.S. These patients suffer failure of the left ventricle, the large main pumping muscle of the heart. Abiomed makes devices that provide circulatory support to acute heart failure patients.
  • Bridge Medical (St. Paul, Minnesota) has introduced two new products, the Telescoping Grip and Telescoping Pivot Grip, offering two portable alternatives when permanent grab bar installation is not possible, or is unnecessary due to a temporary need. Both products come in two sizes, each with the ability to adjust to varying lengths, accommodating the specific needs of the user in any size application area. Two commercial-grade, 4.7-inch diameter grips apply to smooth, flat, non-porous surfaces and feature suction technology, manufactured with non-corrosive metal components.
  • Globus Medical (Audubon, Pennsylvania) reported the introduction of its Niko corpectomy spacer system. The spacer system uses three saggital profiles within the implant system, each which contain at least nine preset heights. The resulting lordosis is contained in the endplate angles and within the shape of the implant itself, enabling surgeons to match the natural anatomy of the body. This feature allows Niko to be immediately implanted, compared to multi-step competitive systems, by eliminating the assembly time of stackable cages or the cutting required with mesh cages. Globus Medical makes spinal implants.