The FDA approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries. The Endeavor is the first drug-eluting stent approved since 2004 and the first since FDA convened its Circulatory System Devices Panel in 2006 to discuss evidence of the rare risk of blood clots occurring in patients who receive drug-eluting stents. Manufactured by Medtronic, Inc., of Minneapolis, the device is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent. It is crimped around a balloon and delivered to the narrowed section of the coronary artery via a long thin catheter during a procedure known as an angioplasty. Once the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in place, acting as a mechanical scaffold to keep the artery open. Slow release of zotarolimus over time prevents the artery from re-narrowing when new tissue begins to form. This process, known as restenosis, can eventually require a repeat angioplasty. Medtronic provided data from seven clinical trials in its marketing application. Studies showed that the Endeavor significantly reduced the number of major coronary events – heart attack, cardiac death and repeat procedures to re-open the artery – compared to a bare-metal stent (a stent without a drug coating). It also cut the restenosis rate by about half. Imaging studies on a subset of patients indicated that the Endeavor’s restenosis rate was higher than what is seen in currently marketed drug-eluting stents. However, the Endeavor had a similar number of coronary events when compared to one of these stents. The number of adverse events experienced by patients implanted with the Endeavor stent was similar to those that occurred in patients implanted with bare-metal stents and existing drug-eluting stents. Based on recent concerns over the rare but serious side effect of blood clots or stent thrombosis, FDA asked Medtronic to combine data from all Endeavor trials to determine how often this happened at various points in time following stent implantation. The stent thrombosis rate was 0.4 percent at one year and 0.5 percent at two years, a rate similar to that for bare-metal stents. To reduce such clotting risk, patients receiving the Endeavor will need to take blood-thinning medication for at least six months after implantation and should consider continuing this regimen for 12 months if they are not at an increased risk for bleeding complications. Patients who are allergic to zotarolimus or to cobalt, nickel, chromium, or molybdenum should not receive an Endeavor stent. Caution is also recommended for people who have had recent cardiac surgery and for women who are nursing or who may be pregnant. Medtronic will continue to follow patients enrolled in six of the Endeavor trials for five years. Additionally, the company will conduct a 2,000-patient U.S. post-approval study, which will be combined with 3,300 patients from a study conducted outside the United States, to assess the long-term safety and effectiveness of the Endeavor stent and to look for rare adverse events such as stent thrombosis. Medtronic will also collect clinical data to identify the optimal duration of blood-thinning medication.
Flamozil Ag is a gentle wound treatment developed by the Belgium Biotech company, Oystershell. This novel gel, combines a carbomer hydrogel for dry and exsudating wounds, with other novel ingredients. Carbomers, in organic chemistry, are expanded 1) ___, also called carbon-molecules. Without parabens, chemicals used as preservatives, Flamozil Ag is preserved by a patented silver dihydrogen citrate complex. Silver has a residual biological effect on skin fibroblasts and accelerates 2) ___ healing. Unlike other woundcare hydrogels, Flamozil Ag is not neutralized with arginine or NaOH. Instead the intrinsic skin factor L-Carnosine is used to stabilize the gel. 3) ___ are becoming increasingly aware of the potential adverse effects of parabens on skin. Methylparaben potentiates UV-induced damage of skin keratinocytes, decreases the proliferating ability of keratinocytes and changes the cell morphology in vitro. 4) ___ also decrease the expression of hyaluronan synthase 1 and 2 and type IV collagen and affect the epidermal differentiation of the skin. Following these concerns the Scientific Committee on Consumer Products (SCCP) of the EU has issued several reports trying to balance the issue and ended with a request to industry for more trial data. In wound care, where the 5) ___ barrier is no longer intact, many researchers believe, it is better to avoid parabens. The silver citrate in this new gel, kills microorganisms by two modes of action: 1) the silver ion deactivates structural and metabolic membrane proteins leading to microbial death; 2) the microorganisms view the silver citrate as a 6) ___ source and internalize it, thus allowing the silver ion to enter as well. Once inside the organism, the silver ion denatures DNA, which halts the microorganisms’ ability to replicate, leading to its death. This dual action makes silver citrate highly and quickly effective against a broad spectrum of 7) ___. In addition, it is aqueous, colorless, odorless, non-irritating, with a long shelf life. Closer to skin 8) ___, by using L-carnosine in the manufacturing (patent pending), a biological buffer is incorporated in the product. L-carnosine is a natural skin factor and has been proven to scavenge ROS (radical oxygen species) as well as unsaturated aldehydes formed from peroxidation of cell membrane fatty acids during oxidative stress. Carnosine also interferes with skin protein cross-linking and glycation phenomena (7) facilitating wound healing. Based on the EPA toxicity categorization, the silver citrate concentration used, is rated in the lowest toxicity category. It is expected that Flamozil Ag, while not an antimicrobial treatment per se, will have a beneficial effect by protecting the wound from microbial infection.
ANSWERS: molecules; 2) wound; 3) Dermatologists; 4) Parabens; 5) skin; 6) food; 7) microorganisms; 8) biology