www. Clinical trial results.org History of Angioplasty and PCI Devices 3000 B.C. – Ultra-thin metal pipes employed by Egyptians to perform bladder catheterizations 400 B.C. – Hollow reeds and pipes used as catheters to study function of cardiac valves in cadavers 1711 – Hales performs the first cardiac catheterization on a horse using brass pipes, a glass tube and the trachea of a goose 1844 – French physiologist Bernard coins the term “cardiac catheterization” and employs catheters to record intra-cardiac pressures in animals 1929 – Dr. Werner Forssmann performs the first documented human cardiac catheterization in Germany 1941 – Two physicians at Columbia University, André Cournand and Dickinson Richards, use the cardiac catheter as a diagnostic tool to measure cardiac output 1956 – Forssmann, Richards and Cournand receive the Nobel Prize with Cournand noting that the “cardiac catheter was... the key in the lock.” 1958 – Dr. Mason Sones of the Cleveland Clinic conducts an imaging procedure of a child’s aortic valve, accidentally engaging the right coronary artery and injecting dye. When the patient’s heart did not display the expected fibrillation, Sones realized he had discovered the key to selective imaging of the heart – the diagnostic coronary angiogram B.C. – Ultra-thin metal pipes employed by Egyptians to perform bladder catheterizations 400 B.C. – Hollow reeds and pipes used as catheters to study function of cardiac valves in cadavers 1711 – Hales performs the first cardiac catheterization on a horse using brass pipes, a glass tube and the trachea of a goose 1844 – French physiologist Bernard coins the term “cardiac catheterization” and employs catheters to record intra-cardiac pressures in animals 1929 – Dr. Werner Forssmann performs the first documented human cardiac catheterization in Germany 1941 – Two physicians at Columbia University, André Cournand and Dickinson Richards, use the cardiac catheter as a diagnostic tool to measure cardiac output 1956 – Forssmann, Richards and Cournand receive the Nobel Prize with Cournand noting that the “cardiac catheter was... the key in the lock.” 1958 – Dr. Mason Sones of the Cleveland Clinic conducts an imaging procedure of a child’s aortic valve, accidentally engaging the right coronary artery and injecting dye. When the patient’s heart did not display the expected fibrillation, Sones realized he had discovered the key to selective imaging of the heart – the diagnostic coronary angiogram. Diagnostic Advancements

www. Clinical trial results.org History of Angioplasty and PCI Devices 1964 – Dr. Charles Dotter with Dr. Melvin Judkins introduces the concept of remodeling arteries, known as transluminal angioplasty, by applying the earlier findings to open blocked peripheral arteries with atherosclerosis 1967 – Dr. Rene Favaloro performs the first saphenous vein graft (bypass) surgery 1967 – Judkins creates his own system of diagnostic imaging, introducing a series of specialized catheters and perfecting the transfemoral approach (introducing the catheter via a groin puncture rather than the more complex procedure used by Sones of introducing the catheter via surgical opening of the brachial artery in the arm) 1974 – Dr. Andreas Gruentzig performs the first human peripheral balloon angioplasty 1976 – Gruentzig presents the results of animal studies involving coronary angioplasty at the American Heart Association meeting 1977 – Gruentzig with Dr. Richard Myler performs the first human coronary angioplasty intraoperatively during bypass surgery in San Francisco 1977 – First cath lab balloon angioplasty performed on an awake patient by Gruentzig in Zurich, and the first case entered into a worldwide registry 1978 – Myler and Stertzer perform the first US PTCA cases 1964 – Dr. Charles Dotter with Dr. Melvin Judkins introduces the concept of remodeling arteries, known as transluminal angioplasty, by applying the earlier findings to open blocked peripheral arteries with atherosclerosis 1967 – Dr. Rene Favaloro performs the first saphenous vein graft (bypass) surgery 1967 – Judkins creates his own system of diagnostic imaging, introducing a series of specialized catheters and perfecting the transfemoral approach (introducing the catheter via a groin puncture rather than the more complex procedure used by Sones of introducing the catheter via surgical opening of the brachial artery in the arm) 1974 – Dr. Andreas Gruentzig performs the first human peripheral balloon angioplasty 1976 – Gruentzig presents the results of animal studies involving coronary angioplasty at the American Heart Association meeting 1977 – Gruentzig with Dr. Richard Myler performs the first human coronary angioplasty intraoperatively during bypass surgery in San Francisco 1977 – First cath lab balloon angioplasty performed on an awake patient by Gruentzig in Zurich, and the first case entered into a worldwide registry 1978 – Myler and Stertzer perform the first US PTCA cases Interventional Advancements

www. Clinical trial results.org History of Angioplasty and PCI Devices 1980 – Guiding catheters are introduced 1982 – Over-the-wire coaxial balloon systems are introduced and brachial guiding catheters and steerable guide wires are developed 1986 – Coronary atherectomy devices are introduced; Puel and Sigwart implant the first coronary Wallstent in France – A large number of new interventional devices are invented and perfected as well as several others approved and used worldwide, including rotational atherectomy devices (Rotablator), intravascular ultrasound (IVUS) and stents 1994 – Palmaz-Schatz stent is approved by the FDA for use in the US – Stents are used commonly, eliminating many complications 1997 – Over one million angioplasties performed worldwide, making it the most common medical intervention in the world 2001 – Almost 2 million angioplasties were performed worldwide, with an estimated 8% increase annually – The first drug-eluting stent, the Cypher, is approved by the F.D.A – Taxus drug-eluting stent approved; many published studies demonstrate the vastly improved outcomes from drug-eluting stents 1980 – Guiding catheters are introduced 1982 – Over-the-wire coaxial balloon systems are introduced and brachial guiding catheters and steerable guide wires are developed 1986 – Coronary atherectomy devices are introduced; Puel and Sigwart implant the first coronary Wallstent in France – A large number of new interventional devices are invented and perfected as well as several others approved and used worldwide, including rotational atherectomy devices (Rotablator), intravascular ultrasound (IVUS) and stents 1994 – Palmaz-Schatz stent is approved by the FDA for use in the US – Stents are used commonly, eliminating many complications 1997 – Over one million angioplasties performed worldwide, making it the most common medical intervention in the world 2001 – Almost 2 million angioplasties were performed worldwide, with an estimated 8% increase annually – The first drug-eluting stent, the Cypher, is approved by the F.D.A – Taxus drug-eluting stent approved; many published studies demonstrate the vastly improved outcomes from drug-eluting stents Interventional Advancements