Pharmacy & Therapeutics - March 2008 - (Page 133) NEW DRUGS autografts or alone, or it may be suitable if a split-thickness autograft is not an option because of the severity and extent of the burn. Description: Autografts are sheets of autologous keratinocytes (skin cells) that replace the epidermis in burn patients. Skin cells are grown or cultured from a small sample of the patient’s own healthy skin. The (human) keratinocytes are grown on a layer of irradiated mouse cells, thus making Epicel a xenotransplantation product. Purpose: Approved under the Humanitarian Device Exemption program, Epicel replaces the skin’s top layer (epidermis) and protects against infection and fluid loss. Benefit: In patients with deep dermal or full-thickness burns, the outer epidermal layer of the skin and most or all of the inner layer (dermis) are destroyed. Because of the depth of the injury, the skin’s ability to regenerate is greatly reduced. With severe burns, not enough donor skin is available to cover the wounds. Epicel offers a means of permanent wound closure. Sources: www.genzymebiosurgery. com; www.fda.gov Name: Exponent Self-Expanding Carotid Stent with Over-the-Wire or RapidExchange Delivery Systems Manufacturer: Medtronic Vascular, Inc., Santa Rosa, Calif. Approval Date: October 26, 2007 Use Classification: The stent is indicated for reopening narrowed regions of the carotid arteries in the neck, which supply blood to the brain. Description: The device consists of a stent and its delivery system. The stent is constructed of a nickel–titanium alloy (nitinol) tubing, laser-cut into a mesh shape. It is mounted onto the delivery catheter. Carotid stents are typically used in conjunction with embolic protection DRUG NEWS Adverse Surgical Event The FDA has advised health care professionals about serious adverse events associated with fragments from devices that have separated unintentionally and remain in a patient after surgery. Patients might not be aware that some fragments have not been retrieved. Each year the FDA Center for Devices and Radiological Health receives nearly 1,000 reports related to these fragments. Events included local tissue reaction, infection, perforation and obstruction of blood vessels, and death. Contributing factors may include biocompatibility of the device materials, location and potential migration of the fragment, and patient anatomy. During MRI, magnetic fields may cause metallic fragments to migrate, and radiofrequency fields may cause them to heat, causing internal tissue damage or burns. Source: FDA, www.fda.gov/med watch/ safety/2008/safety08.htm#Fragments Infusion Pump Recall The FDA has issued a class I recall of Medtronic’s SynchroMed EL Implantable Infusion Pump models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The pump is used to administer drugs to a specific site in the body to treat pain, spasticity, and cancer. It is implanted in the patient, either with or without a side catheter access por t, catheters, and catheter accessories. The models were recalled because of a potential stalling of the pump motor, which affects those infusion pumps with motors manufactured before September 1999. If a pump motor stalls, drug delivery stops suddenly and without warning. This stoppage can cause an interruption of therapy, a return of the patient’s symptoms, symptoms of drug underinfusion, or symptoms of withdrawal. Source: FDA, www.fda.gov I devices (catheter-mounted filters or balloons). After the stent is inserted during angioplasty (less invasive than surgery) it is threaded up to the carotid artery via a catheter inserted in the groin. The embolic protection device is inserted into the blood vessel in the groin and is advanced up to the vessel in the neck, to the site of the blockage. The protection device is deployed, and the device is activated so that it can capture debris generated during stenting. The same wire is used to advance the stent to the blocked area. The stent is then allowed to come out of the catheter and opens automatically over the blockage. After the catheter is removed, the embolic protection device is removed with any pieces of trapped debris. Purpose: The stent is indicated for patients who have had a stroke and at least a moderate blockage (50% or more) in the carotid arteries or patients who have a severe blockage of 80% or more in the neck vessels. Patients should also have a medical condition or an anatomical abnormality that puts them at a high risk if they undergo carotid endarterectomy. Contraindications: Stents should not be used in patients who cannot take blood thinners, who have bleeding disorders, who are allergic to nitinol, whose blockages are at the beginning of the carotid artery, or whose condition might prevent the catheter from reaching the blockage. Benefit: The stent is implanted to open blockages in the carotid arteries in order to prevent future strokes. In a study involving 399 patients, the risk of death, stroke, and heart attack at 30 days or of any stroke in the area of the blockage at one year was similar to rates of complications reported with surger y. The stent allowed blood flow to the brain more than one year later. Source: FDA, www.fda.gov Vol. 33 No. 3 • March 2008 • P&T® 133 http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fragments http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fragments http://www.genzymebiosurgery.com http://www.fda.gov http://www.genzymebiosurgery.com http://www.fda.gov http://www.fda.gov
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