• Covidien (North Haven, Connecticut) reported the U.S. introduction of the AbsorbaTack 5 mm absorbable mesh fixation device for hernia repair. The AbsorbaTack 5mm absorbable tacks provide strong mesh attachment to the surrounding tissues, while reducing the amount of foreign material remaining in the patient long-term. Coupling the absorbable fixation of the AbsorbaTack with Covidien’s Parietex mesh, a hydrophilic polyester mesh that establishes intimate tissue integration, offers an appropriate clinical solution. Covidien specializes in pharmaceutical products, imaging solutions, medical supplies, and retail products.
• The FDA recently expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. Fibrin is a protein that helps blood clot. The sealant, called Evicel, is sprayed or dripped on small, oozing blood vessels. Evicel is made by Omrix Biopharmaceuticals (Kiryat, Israel). Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications. Evicel contains fibrinogen and thrombin, two proteins involved in the production of fibrin. Fibrinogen and thrombin are found in human plasma, the liquid portion of blood. The plasma used to manufacture the product is collected from donors who have been screened and tested for blood-transmitted infections. Omrix is an international bioscience company specializing in innovative, life-saving products.
• Smiths Medical (St. Paul, Minnesota), part of the global technology business Smiths Group, said it has received FDA clearance for its P.A.S. Port T2 Power P.A.C. and Port-a-Cath II Power P.A.C. dual-lumen implantable access systems. The new products expand the existing port line from seven to 10 systems available for power injections of contrast media. Implantable access systems provide a route of delivery for patients requiring long-term medications such as chemotherapy. The portal is implanted under the skin, usually in the chest, and connected to a catheter which threads into a vein. Power-injecting is performed when a patient requires a contrast enhanced computed tomography scan for diagnostic reasons. The power injection procedure requires a higher pressure and flow rate than standard medication infusions so an additional IV line traditionally had to be placed in the patient.
• St. Jude Medical (St. Paul, Minnesota) reported FDA clearance for its EnSite Fusion Registration Module, new software to help physicians create detailed heart models to facilitate the diagnosis and delivery of therapy for complex abnormal atrial heart rhythms, including atrial fibrillation. EnSite Fusion software registers, or integrates, an EnSite System-created chamber model with a three-dimensional computed tomography (CT) model so that the physician has an improved view of the heart’s anatomy to better guide the delivery of therapy. EnSite Fusion has the capability for “dynamic registration,” which allows for adjustments fusing the EnSite System-created and CT-derived models, giving physicians a more detailed image of the heart. Dynamic registration allows physicians to adjust the EnSite System-created model at key anatomic locations to more precisely adapt to the 3-D, CT model.