History of Angioplasty and PCI Devices

1. History of Angioplasty and PCI Devices Diagnostic Advancements • 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.

2. History of Angioplasty and PCI Devices Interventional Advancements • 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

3. History of Angioplasty and PCI Devices Interventional Advancements • 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 • 1987-1993– 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 • 1994-1997– 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. • 2003– The first drug-eluting stent, the Cypher, is approved by the F.D.A. • 2004– Taxus drug-eluting stent approved; many published studies demonstrate the vastly improved outcomes from drug-eluting stents