Pharmacy and Therapeutics - January 2008 - (Page 14) NEW DRUGS fluctuations. Sources: www.pharmacyonesource. com; FDA, July 12, 2007,www. fda.gov. Name: Amplatzer Muscular Ventricular Septal Occluder Manufacturer: AGA Medical Corporation, Plymouth, Minn. Approval Date: September 7, 2007 Use Classification: The occluder is used to repair ventricular septal defects, which often occur in infants. This is the most common type of congenital heart defect. Description: The device is placed via a catheter into the muscular ventricular septum, which separates the two ventricles of the heart, in order to close the defect. The device consists of two discs that are made of self-expanding nitinol. The occluder is delivered through a catheter and expands to place a disc on either side of the defect, closing off the hole between the left and right ventricle. To increase the closing ability, the discs are filled with polyester fabric that is secured to the disc. The Amplatzer inter face is used between the device and the delivery cable. This screw attachment permits the device to be retrieved and repositioned before being released from the cable. Purpose: The occluder is used to close a hole in the heart without the need for open-heart surgery. Precautions: The occluder should not be used if: • the defect is less than 4 mm away from the heart valves. • severe or irreversible pulmonary vascular disease is present. • the patient has a perimembranous or post-infarction ventricular septal defect. • the patient’s weight is below 5.2 kg (about 11 pounds). • the patient has sepsis or an active DRUG NEWS rarely been able to penetrate effectively enough to remove hardened calcium. Sources: www.pharmacyonesource. com; www.cardiovascularsystemsinc. com Precautionary Recall: Knee Implants Smith & Nephew has announced a precautionary recall of artificial knees from the TC-Plus, VKS, and R T-Plus knee ranges. The company was informed by a supplier from the United Kingdom that a limited number of semifinished knee implant castings had a higher iron content than specified. The castings were made this past spring on behalf of the company’s subsidiary, Plus Orthopedics AG. The higher iron content in the implants occurred as a result of a production error at the supplier’s factory. The finished products have been distributed mainly in Europe, and some have been sent to the U.S. and elsewhere. All affected products are now being recalled as a precautionary measure. Of the affected products, about 275 have already been implanted. The recall process is working to determine the status of approximately 300 additional implants; many of these are expected to be located in inventory at distributors and hospitals. The higher iron content should not pose problems of toxicity or biocompatibility for patients. Many orthopedic implants contain iron in much greater percentages. There have been no reports of adverse effects resulting from the use of these implants. Smith & Nephew is conducting laboratory testing to determine whether the durability or the material properties of the implants have been affected. Source: Smith and Nephew, November 30, 2007, www.smithandnephew.com; www.fiercebiotech.com I bacterial infection. • there are contraindications to antiplatelet therapy. Benefit: Implantation of the occluder via a catheter is less invasive than openheart surgery and results in shorter recover y times. The company plans to conduct a five-year post-approval study to evaluate the long-term safety and effectiveness of the device. Sources: www.pharmacyonesource. com; www.fda.gov; www.amplatzer.com; www.medicalnewstoday.com Name: Diamondback 360 Orbital Atherectomy System Manufacturer: Cardiovascular Systems, Inc., Minneapolis, Minn. Approval Date: September 24, 2007 Use Classification: The atherectomy device is used to remove plaque blockages in the peripheral vessels of the legs and to restore blood flow. In patients with peripheral arterial disease, plaque builds up on the inside wall of the blood vessels. The arteries harden and narrow, reducing blood flow to the legs and feet. If the disease progresses, patients can experience pain and critical-limb ischemia, which can result in wounds that do not heal and in eventual amputation. Description: With an orbiting (spinning) action, the device removes hardened, calcified plaque. A tiny, diamondcoated crown uses the principles of centrifugal force to spin at high speeds and sand away plaque while preserving the healthy tissue of the arterial wall. Because the resulting particles are about 75% smaller than red blood cells, there is no need for a distal embolization protection device. Purpose: The atherectomy system is used to treat peripheral arterial disease. Benefit: The device represents a giant step forward in the treatment of diffuse vascular disease. Existing devices have 14 P&T® • January 2008 • Vol. 33 No. 1 http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.fda.gov http://www.pharmacyonesource.com http://www.cardiovascularsystemsinc.com http://www.pharmacyonesource.com http://www.cardiovascularsystemsinc.com http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.amplatzer.com http://www.fda.gov http://www.medicalnewstoday.com http://www.smithandnephew.com http://www.fiercebiotech.com
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