Pharmacy & Therapeutics - January 2009 - (Page 23) NEW DRUGS Approval Date: November 5, 2008 Use Classification: The system is the flagship product within the Align 360 platform, which includes unicompartmental and patello-femoral systems. Description: With this advanced knee platform, the femoral component features a funnel-shaped patella track that accommodates the quadriceps angle anatomy for both men and women, thus saving inventor y costs for operating rooms. Purpose: Unicompar tmental, bi compartmental, and tricompartmental arthritis can be treated surgically. Benefit: Surgeons are able to treat the various stages of a degenerative knee using a minimally invasive approach. Anteromedial overhang of the femoral component, a cause of postoperative knee pain, is reduced. Source: www.cardomedical.com Name: Curos Port Protector Manufacturer: Ivera Medical Corporation, San Diego, Calif. Approval Date: November 13, 2008 Use Classification: The Corus Port Protector is used to decontaminate needle-less intravenous (IV) access ports and to prevent contamination resulting from physical contact and airborne sources. The device reduces the bacterial count of two selected gram-positive bacteria and two selected gram-negative bacteria. Description: This nonsterile device contains 70% isopropyl alcohol and is used to decontaminate needle-less Lueractivated valves. When left in place for 5 to 15 minutes, the port protector decontaminates the injection por t and provides a physical barrier during its intended use. Purpose: In view of the increasing incidence and associated costs of hospital-acquired bloodstream infections, the device should help decrease patient DRUG NEWS notified health care professionals of a correction of the HeartMate II Left Ventricular Assist System of all serial numbers (Catalogue No. 1355 or 102139) distributed since November 2003. Over time, wear and fatigue of the percutaneous lead connecting the blood pump with the system controller may cause damage that could interrupt pump function, potentially causing serious injury or death. Source: FDA, October 28, 2008 Recalls Field generator. The FDA has issued a class I recall of the Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator (Vibe Technologies). The FDA has not approved this device. The company has not submitted any evidence to the FDA to support claims that the product can treat or cure cancer, depression, infection, or pain. The device should not be used, and it should be returned to Vibe. Source: FDA, October 1, 2008 Batter y caps. Animas battery caps, used with the OneTouch Ping System, the 2020 Insulin Pump, the IR1200 Insulin Pump, and the IR1250 Insulin Pump, have been recalled. The caps were manufactured from June 1, 2008, through July 31, 2008, and were distributed from June 16, 2008 through August 1, 2008. The caps were recalled because of a possible intermittent loss of contact between the battery cap and the battery compartment in the pump, causing the device to reset. This failure can prevent the appropriate administration of insulin, which can cause an excess of glucose in the blood. Patients can become confused about the amount of insulin admin istered, and this can contribute to errors in future doses, resulting in suboptimal levels of blood glucose. Source: FDA, November 11, 2008 I exposure to infectious bacteria. Benefit: Bloodstream infections acquired in hospitals dramatically increase the patient’s length of stay, potential mortality, and overall cost of care—more than $5 billion every year in the U.S. alone. At a time when health care systems are reducing payments for treating bloodstream infections, it is hoped that this device will change infection control practices and improve patient care. Sources: www.pharmacyonesource. com; www.fda.gov; www.ivteam.com Name: Apex PTCA Dilatation Catheter Manufacturer: Boston Scientific Corp., Natick, Mass. Approval Date: November 10, 2008 Use Classification: The Apex highperformance pre-dilatation balloon catheter enables physicians to treat challenging atherosclerotic lesions. Description: The device is sold with both Monorail and Over-The-Wire catheter platforms. An inner shaft improves pushability and flexibility. A redesigned tip provides excellent turning and wire tracking. The catheter is available in various balloon diameters ranging from 1.5 mm to 5 mm. Balloon lengths range from 8 mm to 40 mm. Both catheters come in two 1.5-mm designs: the Apex Push Catheter enhances pushability for tight lesions, and the Apex Flex Catheter enhances trackability for tortuous arteries. Purpose. Percutaneous transluminal coronary angioplasty (PTCA) is used to treat coronary artery disease, and the catheter is used to open arteries blocked by atherosclerosis. Benefit: Complex lesions can be dilated with this advanced technology. Sources: www.pharmacyonesource. com; www.bostonscientific.com Devices in the News Faulty lead.Thoratec Corporation has Vol. 34 No. 1 • January 2009 • P&T® 23 http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.fda.gov http://www.ivteam.com http://www.cardomedical.com http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.bostonscientific.com
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