Boston Scientific has submitted to the FDA the final module of the company’s pre-market approval application for its Taxus Liberte paclitaxel-eluting coronary stent system.

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To assess the long-term patency and clinical success of subintimal angioplasty in patients with limb-threatening ischemia. METHODS: From 1999 through 2004, 29 patients with superficial femoral artery (SFA) or popliteal artery occlusion and rest pain or tissue loss underwent subintimal angioplasty. Patients had subintimal wire placement followed by percutaneous transluminal angioplasty and stent placement.

PubMed abstract

Guidant Corporation (NYSE: GDT) March, 9 announced enrollment of the first patient in a first-in-man clinical trial designed to evaluate the safety of a fully bioabsorbable everolimus eluting stent platform for the treatment of coronary artery disease. The trial, called ABSORB, will enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands.

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A new implantable sensor is now providing minimally invasive internal pressure monitoring following endovascular abdominal aortic aneurysm repair (EVAR). Surgeons at the Mount Sinai School of Medicine are leading the way in the testing of internal pressure sensors after EVAR surgery. In a new study published in the Journal of Vascular Surgery, Dr. Sharif H. Ellozy and colleagues at Mount Sinai published their successful breakthrough showing their “continuing clinical experience with the use of a permanently implantable, ultrasound-activated remote pressure transducer.” This development of remote pressure sensing technology and the successful implantation and testing of the device raises the promise of eliminating the need for an invasive measurement technique.

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The purpose of the current study was to evaluate the changes in incidence, clinical characteristics, and indications for emergency coronary artery bypass grafting (CABG) in patients undergoing percutaneous coronary intervention (PCI) from 1979 to 2003.

PubMed abstract

Results from the CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance) trial showed that the combination of the antiplatelet agents clopidogrel and aspirin did not demonstrate a statistically significant reduction in the risk of heart attack, stroke or cardiovascular death compared to placebo and aspirin in a broad population of patients with either established atherothrombotic disease or multiple risk factors for atherothrombotic events. Analysis of the two main patient enrollment subgroups revealed different responses to clopidogrel and aspirin therapy.

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The backup force of a guiding catheter is important for successful percutaneous coronary intervention (PCI), however, no theory has been proposed thus far regarding the factors involved in its generation.

METHODS AND RESULTS: The backup force of guiding catheters was measured in an arterial tree model. In vitro modeling showed that larger-sized guiding catheters had greater backup force (8 Fr > 7 Fr > 6 Fr). Comparing the backup force between transfemoral (TFI) and transradial interventions (TRI), it was found to be 60% greater in TFI with a Judkins L (JL) catheter, and 8% greater in TFI with a backup (EBU/XB) type catheter.

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X-Cell Medical, Inc. announced 8 March that the Company has initiated enrollment in its multinational clinical trial to study the safety and effectiveness of the ETHOS (EsTradiol eluting stents in Humans for restenOSis) II Coronary Stent System.

ETHOS II drug eluting stents (DES) are coated with a second generation formulation of 17(beta)-estradiol, an approved drug used in hormone replacement therapy and other indications. The ETHOS II trial is complimentary to the Company’s ongoing ETHOS I trial, with full 6-month follow-up data to be reported in 2H 2006.

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The aim of the present study was to investigate the prognostic significance of time-delay to peak creatine kinase (CK) after successful direct percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI).

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The CYPHER® Sirolimus-eluting Coronary Stent reduced the risk of target vessel failure (TVF) by almost half in patients who suffered a heart attack (acute myocardial infarction or AMI) compared to those who were treated with the current standard of care (balloon angioplasty and a bare metal stent), according to data presented today during a late-breaking clinical trials session at the 2006 American College of Cardiology Scientific Session.

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To test the feasibility of self-expanding drug-coated nitinol stents for prevention of restenosis in an animal model. Stent implantation in the carotid artery (CA) has been shown to be feasible for treatment of CA stenosis. Even though the restenosis rate in CA is reported to be lower than in the coronary and peripheral arteries, problems may arise with increasing numbers of treated patients and lengthier follow-up.

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Restenosis requiring reintervention limits the long-term success after coronary stent implantation. Thiazolidinediones, like pioglitazone or rosiglitazone, are oral antidiabetic drugs with additional antirestenotic properties. In a randomized, placebo-controlled, double-blind trial, we examined the effect of 6-month pioglitazone therapy on neointima volume after coronary stenting in nondiabetic coronary artery disease patients.

Medline abstract

An American College of Cardiology/American Heart Association (ACC/AHA) Task Force periodically revises and publishes guidelines with evidence-based recommendations for appropriate use of percutaneous coronary intervention (PCI). Some studies have suggested that closer adherence to guidelines can reduce variations in care, can improve quality, and may ultimately result in better outcomes, but this finding is incompletely understood. Guidelines themselves must change to be responsive to continuously evolving clinical practice. Authors goal here was to investigate whether any relationship existed between the most recent ACC/AHA recommended indications for PCI and short term in-hospital outcomes.

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This study aimed to investigate percutaneous coronary intervention patients’ preferences regarding information provision and to identify patient characteristics associated with specific preferences.

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The GENetic DEterminants of Restenosis (GENDER) project is a multicenter prospective study, including 3104 consecutive patients after successful PCI. Forty-eight polymorphisms in 34 genes in pathways possibly involved in the inflammatory process were analyzed.

Abstract