PTCA.us – Angioplasty and stenting digest.

Archive for December, 2005

RX ACCULINKâ„¢ Carotid Stent System by Guidant

December 20, 2005   Categories: Devices  Posted by admin

The RX ACCULINK™ Carotid Stent System is designed to provide easy and accurate stent placement in patients who have carotid atherosclerosis and are at high risk for conventional surgery.  

RX ACCULINK Carotid Stent System Product Specifications (PDF)

Instructions for Use – US Only (PDF)

FDA approval documents

Guidant device page

 


Some stents may cause allergic reactions

   Categories: New articles  Posted by admin

Northwestern Memorial Hospital researchers in Chicago say they’ve discovered some drug-eluting stents can cause serious allergic reactions.

News here


Japanese device maker Terumo ends 15-year pact with Boston Scientific

   Categories: Uncategorized  Posted by admin

Terumo Corp. said Monday it will end its 15-year partnership with Boston Scientific Corp. and begin its own sales, marketing and distribution of wires used to deliver medical treatments through blood vessels.

News


Is there any place for oral anti-restenotic treatment in the era of drug eluting stents?

December 19, 2005   Categories: New articles  Posted by admin

Are drug eluting stents destined to become the standard of care for all patients undergoing percutaneous coronary intervention, or are alternative therapeutic approaches preferable under certain circumstances?

Published in the Heart 2005;91:1377-1379;

Abbreviations: CABG, coronary artery bypass graft surgery; DES, drug eluting stents; MACE, major adverse cardiac events; PCI, percutaneous coronary intervention; TLR, target lesion revascularisation; TVR, target vessel revascularisation
Keywords: drug eluting stents; percutaneous coronary intervention; rapamycin

 


Monitoring Device Safety in Interventional Cardiology

   Categories: New articles  Posted by admin

A variety of post-marketing surveillance strategies to monitor the safety of medical devices have been supported by the Food and Drug Administration, but there are few systems to automate surveillance. Authors objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques.

First published December 15, 2005 as JAMIA PrePrint


Angioplasty catheters: manufacturing and material problems addressed

   Categories: Devices  Posted by admin

This article describes a project to determine the causes of a high failure rate in one manufacturer’s percutaneous transluminal coronary angioplasty catheters. Recommendations for optimal production are outlined.

Full text PDF


Peristent Remodeling and Neointimal Suppression 2 Years After Polymer-Based, Paclitaxel-Eluting Stent Implantation. Insights From Serial Intravascular Ultrasound Analysis in the TAXUS II Study

   Categories: New articles  Posted by admin

The purpose of this study was to evaluate long-term vascular responses as long as 2 years after implantation of polymer-based, paclitaxel-eluting stents in contrast to uncoated stents.

Conclusions–The 2-year follow-up demonstrates that neointimal suppression was dose independent and that this effect was still sustained at 2 years. However, the increase in area outside the stent seen at 6 months regressed to different extents in a dose-dependent manner at 2 years.

Key words: stents • remodeling • restenosis

Published in the Circulation


Cost-benefit of drug eluting stents-time for a reality check

December 16, 2005   Categories: New articles  Posted by admin

Drug-eluting stents (DES) are currently being used in preference to bare stents in the public hospital system in ‘high risk’ lesions on the basis of cost-effectiveness analyses using data from trials which exaggerate their impact and do not include several categories of ‘high risk’. This study aimed to assess the real cost-effectiveness of DES using prospectively collected outcome data from consecutive patients in the immediate pre-DES era.

PubMed abstract


ntracoronary brachytherapy: Initial Australasian experience with the Novoste Beta-Cath system

   Categories: New articles  Posted by admin

In this paper authors describe the initial Australasian experience with the Novoste Beta-Cath device, designed specifically for the delivery of beta radiation to the coronary artery.

PubMed abstract

 


SMT joins Big League of Drug Eluting Stent Manufacturers

December 15, 2005   Categories: Uncategorized  Posted by admin

Sahajanand Medical Technologies Pvt. Ltd. (SMT), the world’s third-largest maker of drug-eluting stents, has just been granted the prestigious CE (“Conformite Europeenne”) Mark — approval from the European Community’s Medicine Evaluation Board (MEB) in the Netherlands — for one of their lead drug eluting stents, the “Infinnium(TM) Paclitaxel System”.

Full news


Percutaneous Coronary Intervention (PCI): 2005 Guideline Update for Percutaneous Coronary Intervention

   Categories: For professionals  Posted by admin

AReport of the American College of Cardiology/American Heart Association Task
Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001
Guidelines for Percutaneous Coronary Intervention)

Percutaneous Coronary Intervention (PCI): 2005 Guideline Update for Percutaneous Coronary Intervention

Full document in PDF (121 pages)


Drug Insight: bleeding after percutaneous coronary intervention-risks, measures and impact of anticoagulant treatment options

   Categories: New articles  Posted by admin

In Europe, the use of interventional cardiology, including percutaneous coronary intervention (PCI), is increasing rapidly. The use of anticoagulation agents in PCI procedures is essential, but despite technical improvements, a significant associated bleeding risk still exists: more than 5% of patients are estimated to require transfusion, and around a further 13% experience minor bleeding. The methods used to detect and measure blood loss following PCI, however, vary widely between institutions and clinical trials.

Review published in the Nature Clinical Practice Cardiovascular Medicine (2005) 2, 465-474–


Medtronic Announces First Clinical Trial Experience With Next-Generation Drug-Eluting Coronary Stent System.

December 14, 2005   Categories: For professionals  Posted by admin

This next-generation drug-eluting stent will use the popular Driver™ bare metal cobalt alloy stent platform and the drug Zotarolimus (ABT-578), along with the proprietary, biocompatible drug delivery polymer developed by Medtronic. Prof. Ian Meredith, Monash Medical Centre, is the principal investigator of the Medtronic RESOLUTE clinical study evaluating the new stent. This first-in-man study will enroll up to 100 patients at 12 clinical sites in Australia and New Zealand.

Full news


CoreValve Successfully Initiates First North American Clinical Trial

   Categories: Uncategorized  Posted by admin

CoreValve Uses its Novel ReValving(TM) System at Montreal Heart Institute to Non-Surgically Replace Diseased Aortic Heart Valve of 64-Year-Old Female Patient Not Eligible for Open-Heart Surgery.

Revalving

 

Graphic by Ed. Wiederer

Full news


Singapore’s Biosensors sued by Boston Scientific/Angiotech over patent

December 13, 2005   Categories: Uncategorized  Posted by admin

Biosensors Group Ltd said it is being sued in the Netherlands by US-based Boston Scientific Corp and Angiotech Pharmaceuticals Inc of Canada over an alleged patent infringement with the sale of its drug-eluting stent (DES) product called Axxion.

Full news