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A process for assembling a medical device made from a nickel-titanium alloy for use in a mammalian body while avoiding the formation of stress-induced martensite and a medical device used in combination with a delivery system for deployment into the mammalian body are disclosed. By heating the nicke

A process for assembling a medical device made from a nickel-titanium alloy for use in a mammalian body while avoiding the formation of stress-induced martensite and a medical device used in combination with a delivery system for deployment into the mammalian body are disclosed. By heating the nickel-titanium alloy of the medical device to a temperature above Md, and deforming and installing the device into a delivery system or holding capsule, it is possible to avoid the formation of stress-induced martensite in the stent, which stays in the austenitic phase throughout.

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1. A process for deploying a medical device including a shape memory alloy element having a martensite deformation temperature (Md) that is greater than a body temperature of a mammalian body, wherein the shape memory alloy element exhibits a restrained shape and a deployed shape for use in the mamm

1. A process for deploying a medical device including a shape memory alloy element having a martensite deformation temperature (Md) that is greater than a body temperature of a mammalian body, wherein the shape memory alloy element exhibits a restrained shape and a deployed shape for use in the mammalian body, the process comprising: heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof;deforming the shape memory alloy element into the restrained shape without generating stress-induced martensite;maintaining the shape memory alloy element in the restrained shape; andself-expanding the shape memory alloy element from the restrained shape to the deployed shape within the mammalian body. 2. The process for deforming a medical device of claim 1, wherein the martensite deformation temperature of the shape memory alloy element is about 50° C. or more than an austenite finish temperature (Af) of the shape memory alloy element. 3. The process of claim 1, wherein maintaining the shape memory alloy element in the restrained shape comprises positioning the medical device including the shape memory alloy element at least partially inside a hollow delivery system to hold the shape memory alloy element in the restrained shape. 4. The process of claim 3, further comprising cooling the medical device positioned at least partially inside the hollow delivery system to room temperature prior to self-expanding the shape memory alloy element. 5. The process of claim 3, wherein the hollow delivery system comprises a catheter. 6. The process of claim 1, wherein the shape memory alloy element is in an austenitic state at room temperature of about 22° C. 7. The process of claim 1, wherein the shape memory alloy element comprises nitinol. 8. The process of claim 1, wherein the medical device comprises a stent. 9. The process for deforming a medical device of claim 1, wherein heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof is performed by a light source. 10. The process for deforming a medical device of claim 1, wherein heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof comprises heating the shape memory alloy element with a heated fluid. 11. The process for deforming a medical device of claim 1, wherein heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof comprises heating the shape memory alloy element by ultrasonic vibration. 12. The process for deforming a medical device of claim 1, wherein heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof comprises heating the shape memory alloy element with a current source connected to the shape memory alloy element. 13. The process for deforming a medical device of claim 1, wherein heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof comprises heating the shape memory alloy element by rolling the shape memory alloy element on a warm plate. 14. A process for deploying a medical device including a shape memory alloy element having a martensite deformation temperature (Md) that is greater than a body temperature of a mammalian body, wherein the shape memory alloy element exhibits a restrained shape and a deployed shape for use in the mammalian body, the process comprising: heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof;while the shape memory alloy element is at or above the martensite deformation temperature, deforming the shape memory alloy element into the restrained shape without generating stress-induced martensite;maintaining the shape memory alloy element in the restrained shape; andself-expanding the shape memory alloy element from the restrained shape to the deployed shape within the mammalian body. 15. The process for deforming a medical device of claim 14, wherein heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof is performed by a light source. 16. The process for deforming a medical device of claim 14, wherein heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof comprises heating the shape memory alloy element with a heated fluid. 17. The process for deforming a medical device of claim 14, wherein heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof comprises heating the shape memory alloy element by ultrasonic vibration. 18. The process for deforming a medical device of claim 14, wherein heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof comprises heating the shape memory alloy element with a current source connected to the shape memory alloy element. 19. The process for deforming a medical device of claim 14, wherein heating the shape memory alloy element to a temperature at or above the martensite deformation temperature thereof comprises heating the shape memory alloy element by rolling the shape memory alloy element on a warm plate. 20. The process of claim 14, wherein the medical device comprises a stent.