Pharmacy & Therapeutics - November 2008 - (Page 630)

NEW DRUGS Name: Talent Thoracic Stent Graft Manufacturer: Medtronic, Inc., Minneapolis, Minn. Approval Date: June 5, 2008 Use Classification: The graft is used to repair fusiform and saccular aneurysms or penetrating ulcers of the descending thoracic aorta. When placed within the lesion, the stent graft provides an alternative conduit for blood flow. Description: Nitinol wire rings, acting as springs, are stacked in a tubular arrangement to form a self-expanding structure. Proximal and distal springs of the stent graft are connected by a full-length connecting bar. A monofilament polyester-woven graft covers the nitinol structure. The graft material is sewn to the structure, which incorporates the springs into the graft. Platinum–iridium radiopaque markers, in the shape of a figure eight, are sewn to the graft to help visualize the edge of the graft material, the location of the connecting bar, and the minimum overlap required when multiple stent grafts are used. A support spring is also used in some configurations. Purpose: This stent graft is used to treat thoracic aneur ysms, which can rupture without warning. The graft is threaded through a small opening in the femoral artery of the leg. The stent is advanced under fluoroscopic guidance to the site of the thoracic aortic aneurysm or dissection, where it is deployed. The stent graft then expands to fit within the aorta and provides a new path for the blood flow. Benefit: The system is less invasive than open heart surgery. Sources: FDA, www.fda.gov; www. medtronic.com Name: Evolution Controlled-Release Esophageal Stent System Manufacturer: Cook Medical, San Diego, Calif. Approval Date: June 9, 2008 DRUG NEWS provide the shock. Physio Control, a division of Medtronic, has informed customers that their AEDs would be replaced immediately. Source: FDA, www.fda.gov Catheters and Kits. June 26, 2008: The FDA has classified its safety alert about the proper connection of sutureless catheters used with implantable drug-infusion systems as a class I recall. The notification relates to the improper connection of Medtronic’s Indura 1P Intrathecal Catheter (model 8709SC), the Intrathecal Catheter (model 8731SC), the Sutureless Pump Connector Revision Kit (model 8578), and the Intrathecal Catheter Pump Segment Revision Kit (model 8596SC). Medtronic had received 83 reports of problems about the infusion system that have been attributed to either an occlusion or a disconnection of the sutureless catheter from the pump. The events were caused by misalignment or incomplete connection of the sutureless connector on the catheter to the catheter port on the pump during the implantation procedure. If an occlusion occurred, the catheter port might have become embedded in the inner wall of the connector seal instead of aligning with the connector. An improper attachment can cause damage to the catheter connector, leaks at the connection site, or disconnection of the catheter after implantation. Signs of occlusion can include a lack of therapeutic effect, a significant or fatal drug overdose, a return of underlying symptoms, or symptoms of drug withdrawal. Patients receiving intrathecal baclofen (e.g., Lioresal, Intrathecal) are at higher risk for adverse events, because baclofen withdrawal can lead to a lifethreatening condition without prompt treatment. Sources: FDA, www.fda.gov; www. medtronic.com I Use Classification: The stent is used to improve quality of life for patients with advanced esophageal cancer that cannot be treated surgically. Description: Dual flanges secure the stent, reducing the risk of stent migration after placement. The stent’s internal and external silicone coating helps to resist tumor ingrowth into the stent and enhances the patients’ ability to swallow food normally instead of eating through a tube. A retractable deliver y system facilitates direct monitoring of stent placement, and an indicator allows physicians more control in placing the stent. With each squeeze of the stent’s triggerbased introducer, a proportional length of the stent is deployed or recaptured. A directional button enables seamless switching from deployment to recapture mode, and the “point-of-no-return” mark alerts the physician when recapture is no longer available. Even after this point, repositioning may still be an option. Purpose: The stent is used in patients with esophageal cancer. Benefit: The ability to place the stent precisely the first time may reduce the need for additional procedures. Sources: www.pharmacyonesource. com; www.cookmedical.com Device Recalls LifePak CR Plus Automated External Defibrillator. August 28, 2008: Manu- factured from May 20, 2004, through August 11, 2007, this AED was distributed from May 20, 2004, through December 4, 2007 (Nos. 3200731-003 and 3200731027). By analyzing the heartbeat in an unconscious patient, the device automatically delivers an electrical shock to the heart to restore normal rhythm. AEDs ordinarily instruct the responder, by voice prompts, to press the shock button. This device was recalled because the shock button was covered and was not visible; thus, the responder could not 630 P&T® • November 2008 • Vol. 33 No. 11 http://www.fda.gov http://www.pharmacyonesource.com http://www.cookmedical.com http://www.pharmacyonesource.com http://www.fda.gov http://www.medtronic.com http://www.medtronic.com http://www.fda.gov http://www.medtronic.com http://www.medtronic.com

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Pharmacy & Therapeutics - November 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Heparin-Induced Thrombocytopenia Medication Utilization Patterns and Hypertension-Related Expenditures among Patients Who Were Switched From Fixed-Dose to Free-Combination Antihypertensive Therapy European Society for Medical Oncology and Association for the Study of Bone and Mineral Research Pharmaceutical Approval Update

Pharmacy & Therapeutics - November 2008

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