Drug-eluting stent

trial? BME 5950 Special topics in BME – FDA regulation Zhenlin Huang Outline I. What is the combination product? 1. Definitions of combination product 2. The major three components: drug, device, and biologics. II. Case study: drug-eluting stent 1. History of drug-eluting stent 2. The first FDA approved drug-eluting stent 3. Review responsibility of FDA approval on the DES 4. Other further investigations 5. Discussions III. Case study: regenerative medicine 1. Combination product in regenerative medicine

angioplasty and Bare-metal stents failed to demonstrate durability because of the high rate of restenosis following endovascular procedure which could occur early after treatment (Falkowski et al. 2009) The lack of recognized durable antirestontic result after plain balloon angioplasty lead to the investigation of alternative procedures. After the success of drug-eluting stents in decreasing coronary restenosis after percutaneous coronary interventions, drug-eluting stent was recommended as salvage

[1]. 1.1 - Bare Metal Stents (BMS) By the mid 1980’s, bare metal stents (BMS) were developed to overcome the limitations of balloon angioplasty [1]. Coronary stents are metal lattices that hold the vessel open, which prevents recoil following angioplasty [2]. They are delivered using a catheter-mounted balloon inserted either in the brachial or femoral artery, which is then threaded to the site of blockage in the coronary artery. The balloon is inflated, and the stent is released covering the

prolong the effects of this. Treatments for this have undergone major developments over the past 40 years, including balloon angioplasty in 1977, development of bare-metal stents (BMS) in the 1980’s, introduction of drug-eluting stents (DES) in 2000 (43) and current research into incorporating NO donors into stents. The first stent implantation performed on a human was conducted in 1986 (13), since then they have become one of the most common ways of intervention due to atherosclerosis. In the US there

new bioabsorbable polymer drug-eluting stents impact DAPT duration? Ian J Sarembock, MB, ChB, MD, FACC; Dean J Kereiakes, MD, FACC
The Heart & Vascular Service Line and The Lindner Center for Research and Education, The Christ Hospital Health Network, Cincinnati, Ohio The evolution of percutaneous coronary intervention (PCI) from plain old balloon angioplasty (POBA) in 1977, to bare metal stents (BMS) in 1986, through the revolutionary introduction of drug-eluting stents (DES) in 2003 which successfully

bout of gastroenteritis. She has made a full recovery and is about to be discharged. You took a medication history from her when she was admitted and recorded that she was taking aspirin 100mg daily and clopidogrel 75mg daily after having had a drug eluting stent inserted 6 months previously. Her other admission medications include metformin 1g daily, perindopril 5mg daily. Mrs JL’s discharge script includes all the medications on admission except the clopidogrel. Is it Ok to cease the clopidogrel in

structure, a bare-metal stent (BMS) is an elaborate mesh-like tube having a thin wall (stent platform) without a drug coating. The first stents that were licensed were made up of bare metal (316L stainless steel). The second generation of stents was composed of cobalt chromium alloy. There is another stent which called A drug-eluting stent (DES) that involves a stent platform with the drug to help the patient prevent from having the abnormally narrowed arteries again. The stent platform is an expandable

2014 1. a. Bare-metal stents (BMS) and drug eluding stents (DES) essentially have the same tube like structure and generally consist of the same metal alloy composition of the wires. However, unlike the bare metal stents (BMS), the drug eluting stents (DES) are coated with a polymer which holds and eludes a drug such as paclitaxel or sirolimus which aids in the inhibition of restenosis. http://en.wikipedia.org/wiki/Drug-eluting_stent b. “Off-label” use of drug eluding stents (DES) constitutes the

(“Balloon Angioplasty and Stents”, 2015). Angioplasty involves using a balloon to compress the plaque against the arterial wall in order to clear the blockage, but there is debate as to which procedure is optimal in minimizing risk of complications after the procedure (“Balloon Angioplasty and Stents”, 2015). According to “Balloon Angioplasty and Stents” (2015) these two procedures often go hand in hand, in fact, “about 80% of patients who have balloon angioplasty will have a stent placed as well.” This

with a ballon catheter and an endeavor drug eluting stent was deployed in the blood vessel. The patient left without any complications on a medical therapy. Ten months later, the angiogram of the patient revealed a Grade IV Stent Fracture and a substantial in-stent restenosis (Appendix 1). Problem Description: We believe that the endeavor stent failed and led to a substantial in-stent restenosis because the 316L stainless steel material used in the stent, wasn’t strong enough to bear the radial