A U.S. Manufacturer is developing a medical device which is a Sirolimus-Eluting Coronary Stent with an integrated delivery system.
A U.S. Manufacturer is developing a medical device which is a Sirolimus-Eluting Coronary Stent with an integrated delivery system.
This medical device is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to atherosclerotic lesions ≤ 24 mm in length in native coronary arteries with ≥ 2.25 mm to ≤ 4.00 mm reference vessel diameters, using direct stenting or pre-dilatation interventional techniques.
The medical device and its integrated system are contraindicated for use in patients:
o Unable to receive antiplatelet and/or anticoagulant therapy,
o With known hypersensitivity to sirolimus, PEA III Ac Bz, cobalt, chromium, nickel, tungsten, or contrast media,
o Judged to have lesions preventing complete inflation of an angioplasty balloon or proper placement of a coronary stent or delivery system, including chronic total occlusions.
A. Research Task
A U.S. Manufacturer is developing a medical device which is a Sirolimus-Eluting Coronary Stent with an integrated delivery system.
Identify the medical device in the FDA database and download its approval history. Information to look for should include:
Labeling,
Safety and effectiveness information,
Clinical trials information,
Any post-market supplements to date.
Sample Solution