Medtronic, Inc. (NYSE: MDT) yesterday announced that enrollment has begun in its ENDEAVOR IV Clinical Trial, the final phase of its ENDEAVOR Clinical Program to be used in support of U.S. Pre-Market Approval (PMA) approval. The first patient implant in the trial was performed yesterday by Charles O’Shaughnessy, M.D., at EMH Regional Medical Center, Elyria, Ohio.

The ENDEAVOR I Clinical Trial was a 100-patient, prospective, multi-center trial studying the safety and efficacy of the Endeavor Drug Eluting Stent for the treatment of de novo coronary lesions in native coronary arteries. The trial was conducted at sites in Australia and New Zealand. The Endeavor stent demonstrated positive 12-month clinical results, including a MACE rate of only 2.0 percent; a Target Lesion Revascularization (TLR) rate of only 1.0 percent, and an Angiographic Binary Restenosis (ABR) rate of 5.4 percent.

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by Ever D. Grech

Synopsis
(BMJ Books) Northern General Hospital, Sheffield, UK. Describes and illustrates various methods of interventional cardiology. Includes the pathophysiology and investigation of coronary artery disease, percutaneous coronary intervention, chronic stable angina, interventional pharmacotherapy, implantable devices, and more. Softcover.

Product Information:
ISBN: 0727915460
Publisher: BMJ PUBLISHING GROUP
Format: Paperback, 51 pages
Pub Date: 01/2004
Edition Number: 1
ABC of Interventional Cardiology

AIMS: To evaluate the outcomes of sirolimus-eluting stent (SES) implantation for the treatment of chronic total occlusion (CTO).

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Formation of coronary aneurysm is a rare complication of stenting with bare metal stents, but based on experimental studies drug-eluting stents may induce toxic effects on the vessel wall with incomplete stent apposition, aneurysm formation and with the potential of stent thrombosis or vessel rupture.

Abstract

Keywords: coronary aneurysm, drug‐eluting stent, intravascular ultrasound, paclitaxel, stent malapposition

Cook Inc. has started safety trials on patients of a drug-coated stent for the femoral artery in the leg, hoping to become the first company to sell coated stents for nonheart uses.

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Treatment of bifurcation lesions is associated with high procedural complications and restenosis rate due to plaque shift, suboptimal angiographic results, difficulty in crossing the stent struts, and incomplete coverage of the side-branch ostium. The simultaneous kissing stent (SKS) technique involves two stents, one in main vessel (MV) and one in the side branch (SB) with overlapping stents in the MV proximally, extending proximally the carina of bifurcation.

PubMed abstract

Abbott Park, Illinois, April, 11, 2005 — Abbott Vascular, a division of Abbott and a market leader in vessel closure, today announced the submission of a Premarket Approval application to the U.S. Food and Drug Administration (FDA) for its StarClose™ Vascular Closure System, a next–generation vessel closure system specifically designed for the simple, quick and secure mechanical closure of femoral arteries following catheterization procedures, such as angioplasty and stent placement.

Full press releases

By Deepak L. Bhatt

Reviews the current knowledge of interventional cardiology and covers such key topics as cardiac and peripheral intervention, case and equipment selection, adjunctive pharmacology, and device selection. Material is presented in concise, question/answer format. For physicians and residents.

Product Information:
ISBN: 1901346609
Publisher: REMEDICA PUBLISHING
Format: Paperback, 181 pages
Pub Date: 01/2004

Essential Concepts in Cardiovascular Intervention

This retrospective observational review compares patient characteristics and in-hospital and long-term outcomes of cohorts of patients undergoing percutaneous coronary intervention (PCI) for cardiogenic shock complicating acute myocardial infarction (MI) prior to the use of stents (as well as glycoprotein IIb/IIIa inhibitor and dual-antiplatelet therapy) with PCI in the stent era.

PubMed abstract

The purpose of the Euro Heart Survey Programme of the European Society of Cardiology is to evaluate to which extent clinical practice endorses existing guidelines as well as to identify differences in population profiles, patient management, and outcome across Europe. The current survey focuses on the invasive diagnosis and treatment of patients with established coronary artery disease (CAD).

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In-stent restenosis (ISR) represents the major limitation of stent implantation. Treatment, although of relative technical ease, is unsatisfactory due to a high incidence of recurrent restenosis. Vascular brachytherapy (VBT) has emerged as a powerful adjunct therapeutic modality to treat ISR. Inhibition of neointima formation has been regarded as the relevant mechanism of action.

Abstract

Key words Coronary artery disease – in-stent restenosis – vascular brachytherapy – intima hyperplasia – remodelling

Paclitaxel In-Stent Controlled Elution Study

PPT Presentation

Principal Clinical and Angiographic Results from the TAXUS-V Pivotal Randomized Trial, by GW Stone

Presentation

By Robert D. Safian

Synopsis

William Beaumont Hospital, Royal Oak, MI. Instructional atlas presenting more than 200 common and uncommon problems faced by interventional clinicians daily. Features the decision-making processes and opinions of the contributors. 36 contributors, 26 U.S.

Product Information:
ISBN: 1890114278
Publisher: Physicians Press
Format: Paperback, 713 pages
Pub Date: 01/1997

Tough Calls In Interventional Cardiology: An Instructional Atlas

Secretory phospholipase A2 type IIA (sPLA2) may actively contribute to atherogenesis, acting either within the arterial wall or in plasma. Proinflammatory eicosanoids and lysophospholipids, generated through hydrolysis of cell membrane phospho-lipids by sPLA2, initiate and prolong the inflammatory process. In the present study we examined the possible involvement of sPLA2 in development of restenosis in patients undergoing percutaneous transluminal coronary angioplasty (PTCA).

PubMed Abstract