The U.S. Food and Drug Administration (FDA) approved revised instructions for use (IFU) for the CYPHER® Sirolimus-eluting Coronary Stent. The labeling now reflects FDA’s review of clinical trial data that suggests there is no increased risk of myocardial infarction (heart attack) with the use of overlapping CYPHER® Stents in comparison to bare metal stents. This labeling change is based on a retrospective analysis of several clinical studies of overlapping CYPHER® Stents examining more than 900 patients.

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Guidant Corporation (NYSE: GDT) today announced that the company has received Conformité Européene (CE) Mark approval for the XIENCE™ V Everolimus Eluting Coronary Stent System. This regulatory certification allows Guidant to begin marketing the drug eluting stent in the 25 countries of the European Union. In addition, the CE Mark Approval is used to support market registrations in other regulated countries including those within Asia, Latin America and Eastern Europe.

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Radiation skin injuries have been reported as a result of various procedures, so in the present study the patients’ entrance skin dose (ESD) during percutaneous coronary intervention (PCI) was evaluated.

Published in the Circulation Journal

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Early reperfusion with angioplasty and stenting is established as a central, effective treatment for acute myocardial infarction (AMI). The role of thrombectomy prior to angioplasty remains to be elucidated. To evaluate its feasibility, safety, and efficacy, thrombectomy using a TVAC aspiration catheter system was attempted prior to angioplasty and stenting in 40 consecutive patients with AMI.

Abstract

Key words:  Acute myocardial infarction - Primary angioplasty - Thrombectomy - ST resolution

edited by Patrick W. Serruys and Anthony H. Gershlick

Over the past few years, the focus in interventional cardiology research has centered on reducing restenosis with the use of antiproliferative pharmacological agents.

The use of these drugs, hitherto, has failed, most probably because of low active drug levels at the target site.

This problem led to the development of local drug delivery using stents, since they can serve as a reservoir for local drug administration and are in immediate contract with the coronary artery wall, thus ensuring maximum delivery of the pharmacological agent.

Drug-eluting stents provide an entirely new spectrum of potential therapies for restenosis.

Drug Eluting Stents Handbook provides the reader with up-to-date information on which stents and pharmacological agents in use or about to be launched, the kinetics of the drugs involved, and what the future may hold

Handbook of Drug-Eluting Stents

Contents:

1. Historical Notes of Early Failures and Later Successes with Local Drug Delivery
2. The Clinical Problem of Restenosis
3. Histopathology of Restenosis Cellular Mechanism of Restenosis, with Conventional Dogma And Novel Therapies
4. Molecular Basis of Restenosis: Potential Target and Agents for Local Drug Delivery
5. Principles and Kinetics of Stent-Based Drug Elution
6. Importance of the Toxic/Therapeutic Window
7. Importance of the Polymer
8. The Importance of the Drug Platform: Coated, Uncoated, Sleeves, and New Concepts
9. Cypher Programme of Cordis/Johnson & Johnson
10. Rapamycin Structures and Mechanism of Action
11. Rapamycin: Preclinical Studies
12. Non-Randomized Registries for De Novo Lesion (FIM) and Instent Restenosis
13. Randomized Trial (RAVEL) and Further Clinical Developments (SIRIUS)
14. Quanam Programme with Taxol Derivative (PILOT Study and SCORE Trial)
15. Taxus Programme of Boston Scientific
16. Paclitaxel Structures and Mechanism of Action
17. Preclinical Studies for the Taxus Programme
18. Non-Randomized Registries for De Novo Lesion (TAXUS I) and Instent Restenosis (TAXUSIII)
19. Randomized Trial (TAXUS II And IV) and Further Clinical Developments
20. The Cook Inc Paclitaxel Programme
21. Preclinical Studies
22. Clinical Programme
23. Aspect Patency Elutes and Future Studies
24. VEGF
25. The Guidant Actinomycin-D/Pharmalink Programme
26. Actinomycin Structures and Mechanisms of Action
27. Actinomycin: Preclinical Studies
28. Randomized Trial (ACTION, Europe; and OPEN USA) and Further Clinical Developments
29. The Biodivisio Programme
30. Angiopeptin: Mode of Action, Preclinical and Clinical Studies (SWAN)
31. Batimastat: Mode of Action, Preclinical and Clinical Studies (BRILLIANT)(BATMAN)(ROBIN)(DISTINCT)
32. Matrix Compounds
33. Dexamethasone: Mode of Action, Preclinical and Clinical Studies (STRIDE)
34. 17-Beta-Estradiol
35. Medtronic Programme
36. Antisense Oligonucleotides Against C-Myc (AVI4126 Biopharma): Current Status and Future
37. Developments
38. Orbus Programme of Eluting Stents
39. Igaki Tamai Programme
40. Biodegradable Stent (Tranilast and Inhibitors of Tyrosine Kinase)
41. Terumo Programme
42. Terumo Statin Releasing Stent (Preclinical Results)
43. JOMED Programme
44. Potential Agents in Development
45. Halofuginone, a Collagen Inhibitor

The pharmaceutical giant lost the bidding battle for Guidant, meaning it has plenty of cash for acquisitions. There are quite a few possibilities.

Johnson & Johnson (JNJ) finally blinked. After weeks of a bidding war, J&J walked away from its $71-a-share deal to acquire device maker Guidant (GDT). Guidant will now be bought by J&J rival Boston Scientific (BSX), which has agreed to pay $80 a share, or $27 billion, for the company. J&J’s consolation prize: a breakup fee of $705 million.

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Federal regulators said Thursday that inspections at Boston Scientific Corp. plants found companywide problems in the medical device maker’s quality control, a finding that could block new product approvals as the company tries to conclude its biggest acquisition ever.

“We are directing them to resolve these serious violations promptly, and to do it not as it relates to specific products … but rather to do it on a corporate-wide basis,” said Daniel G. Schultz, director of the Food and Drug Administration office that regulates medical devices.

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Aims To evaluate the pre-clinical feasibility of real-time magnetic resonance imaging (rtMRI) to guide stent-graft placement for experimental aortic dissection (AD) and to alleviate disadvantages of ionising radiation and nephrotoxic contrast media. Endovascular stent-graft placement for thoracic aortic disease is usually performed under X-ray guidance. The feasibility of rtMRI-guided stent-graft placement is currently not known.

Abstract

Keywords: Magnetic resonance imaging; Endovascular aortic dissection; Stent-graft intervention.

From patient selection and monitoring to follow-up care, Carotid Interventions is the first source to offer a practical how-to approach to carotid angioplasty and stenting-providing maneuvers and strategies for difficult situations, as well as step-by-step guidance on specific surgical procedures, equipment selection and instrumentation, protection devices, and room/facility layout.

Carotid Interventions

An increasingly common and effective method for the treatment of atherosclerotic disease in the coronary arteries is percutaneous transluminal coronary angioplasty (PTCA) and stenting. The stents are made of different metals. An increased rate of restenosis when using gold-plated stents has been shown. Contact allergy to gold is common in many countries. Recently, a study has shown an increased rate of contact allergy to nickel among patients with restenosis and a nickel-containing stent.

Abstract

Success of coronary stenting is limited by in-stent restenosis. Authors aimed to determine whether circulating levels of the cytokines, which have anti-inflammatory properties such as adiponectin or interleukin-10, could be associated with the occurrence of coronary in-stent restenosis in patients with end-stage renal disease (ESRD).

PubMed abstract

MIAMI, Jan. 24 (UPI) — Researchers said Tuesday that applying drug coating to an angioplasty balloon might remove the need for a stent.

At this week’s Endovascular Therapy Symposium in Miami, researchers said they successfully used drug-coated angioplasty balloons to open narrowed and blocked blood vessels in the legs.

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Abbott ABT today announced financial results for the fourth quarter and full year ended Dec. 31, 2005.

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An interactive website that showcases the marvel of the cardiovascular system, why and how medical problems arise, and treatment and lifestyle options that promote a heart health.

http://www.invisionguide.com

The U.S. Food and Drug Administration (FDA) approved revised instructions for use (IFU) for the CYPHER(R) Sirolimus-eluting Coronary Stent. The labeling now reflects FDA’s review of clinical trial data that suggests there is no increased risk of myocardial infarction (heart attack) with the use of overlapping CYPHER(R) Stents in comparison to bare metal stents. This labeling change is based on a retrospective analysis of several clinical studies of overlapping CYPHER(R) Stents examining more than 900 patients.

The CYPHER(R) Stent is the only drug-eluting stent with this new label.

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