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A protocol is proposed for the selection of a safe, effective, and reliable pacemaker encapsulant. The material properties necessary for this application are discussed with emphasis on those which are important in the encapsulation of a chemical battery discharging hydrogen gas.
A brief review of the methods established for the thrombogenicity testing of materials to be used in cardiovascular devices is given. A modified version of the Gott canine inferior vena cava test is described along with test results for 10 polymeric and carbonaceous materials.
A discussion is presented of the major material and structural variables in textiles relevent to their performance in biomedical devices.
Using a new dialysis membrane highly permeable to middle molecules and a closed loop dialysate delivery system, the author has tested the middle molecule hypothesis in a tentative way for understanding the uremic syndrome through hemodialysis.
Composite materials technology is applied to the design, fabrication, and testing of a mechanically anisotropic vascular prosthesis. A 4-ply laminated tube made from a segmented polyetherurethane is described and the effect of various environments on the laminate integrity is discussed.
A fundamental approach to the design of a new trileaflet prosthetic heart valve has involved basic studies in anatomy and biomaterials and complex stress analyses of the normal human aortic valve. These data have provided the keystones for design.
The FDA has established no standard for safety and efficacy of plastics used with medical devices. The term “medical grade plastic” is an industrial term with no defined values. New legislation is needed to assure the patient of the lack of toxicity, acute and chronic, from device materials.
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