Pharmacy & Therapeutics - June 2008 - (Page 368)

NEW DRUGS continued from page 334 DRUG NEWS rowing again when new tissue begins to form. Restenosis often results in the need for a second angioplasty. During angioplasty, a long, thin catheter is used to deliver the stent to the narrowed section of the coronary artery. After the stent is in place, the balloon is inflated and expands into the vessel wall to keep the artery open. Purpose: The coated stent keeps the coronary artery open. Benefit: In clinical studies, the Endeavor stent, compared with a bare-metal stent, reduced the number of major coronary events, including heart attacks, cardiac death, and repeated procedures to reopen the artery. The zotarolimus stent also reduced the restenosis rate by about half. This is the first drug-eluting stent approved since 2004 and the first one since the FDA convened its Circulatory System Devices Panel in 2006 to discuss evidence of the rare risk of blood clots after patients received drug-eluting stents. Medtronic plans to follow patients enrolled in six Endeavor trials for five years. Contraindications: Patients who are allergic to zotarolimus, cobalt, nickel, chromium, or molybdenum should not receive an Endeavor stent. Caution is recommended for patients who have had recent cardiac surgery and for women who are nursing or who might be pregnant. Sources: wwwp.medtronic.com; www.fda.gov Name: RestoreULTRA Neurostimulation System Manufacturer: Medtronic, Inc., Minneapolis, Minn. Approval Date: February 6, 2008 Use Classification: The neurostimulator is used to treat chronic, intractable back and leg pain. Description: This neurostimulator is a fully implanted system with a rechargeable battery. Its compact shape allows for greater flexibility when physicians choose an implant site, and it is suitable for patients of all sizes. Purpose: As the smallest and thinnest 16-electrode neurostimulator available, the device is intended for patients with pain after laminectomy or failed back surgery syndrome, unsuccessful disk surgery, degenerative disk disease, and other causes. Benefit: A remote control feature allows patients to increase or decrease the intensity of electrical impulses and to customize therapy at home. Patients who use the medium setting for stimulation can go at least two weeks before they need to recharge the device, and they can move around when recharging it. The system’s small size provides improved patient comfort. Clinicians can treat several pain sites at the same time. Sources: www.pharmacyonesource.com; www.medtronic. com I 368 P&T® • June 2008 • Vol. 33 No. 6 http://wwwp.medtronic.com http://www.fda.gov http://www.pharmacyonesource.com http://www.medtronic.com http://www.medtronic.com

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Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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