FDA Clears for Market First Decellularized Heart Valve - The U.S. Food and Drug Administration today cleared for marketing the first replacement heart valve from donated human tissue in which the cells have been removed.
Traditionally, when human tissue is recovered from a cadaver for future implantation, it is inspected, cleaned and decontaminated to prevent infection, but the allograft product remains otherwise unchanged. CryoLife Inc. has added a manufacturing step to its CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft (SynerGraft) that decellularizes or removes the tissue's cells and cellular debris. What remains is a scaffold of connective tissue that still functions like a human heart valve, potentially lowering the risk of an immune response and subsequent tissue rejection.
"Today's clearance is a promising advance in allograft products," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA welcomes innovations in manufacturing that provide more medical options for patients."
Allograft (human) heart valves are popular choices for children because they avoid the need to take blood-thinning medications on a long-term basis. Allograft heart valves are also less likely to calcify than heart valves from a pig or cow.
The pulmonary valve directs blood flow from the right ventricle to the lungs. The SynerGraft valve is for use in patients who require replacement of their pulmonary valve because of disease, malformation or malfunction of their own pulmonary valve or as part of another surgical procedure.
The FDA cleared the SynerGraft valve based on clinical data comparing 342 SynerGraft valves (implanted between the years 2000 and 2004) to 1,246 traditional allograft heart valves sold by the company. The data included information on mortality, device-related re-operations, structural valve deterioration, endocarditis (an inflammation of the heart's inner lining) and blood clots. The FDA found that the SynerGraft valve performed at least as well as traditional allograft valves.
CryoLife is based in Kennesaw, Ga.*
Actavis Recalls Certain Fentanyl Patches in the US as Precaution -
Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that 14 lots of Fentanyl transdermal system CII patches sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies as a precaution.
The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC.
Fentanyl patches sold by Actavis in Europe are not affected by this recall.
The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Although unaware of any injuries resulting from this issue Actavis, as a precaution, is recalling these lots. As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.*
Cough and Cold Medications in Children Less Than Two Years of Age - FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory and a previous MedWatch alert dated January 12, 2007, regarding this issue.
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