The FDA has issued a Class I recall of AngioSculpt’s EX Percutaneous Transluminal Coronary Angioplasty (PTCA) scoring balloon catheters, after it was found that the devices may fragment and become lodged in a patient’s coronary arteries, resulting in serious injuries and even death.   Read more...

The European Union (EU) has granted Medtronic a CE mark for its CoreValve delivery system with AccuTrak Stability layer, which is used during transcatheter aortic valve implantation.   Read more...

AtheroMed has begun enrolling patients into the EASE (Endovascular Atherectomy Safety and Effectiveness) trial that will evaluate the safety and effectiveness of the Phoenix Atherectomy catheter, a device used to treat peripheral arterial disease (PAD).   Read more...

This year, 221 U.S. cardiac surgery sites publicly reported the results and outcomes of CABG procedures performed, and only five reported ratings that were below average or rated one star on the three-star scale used. But, the system of accountability continues to fuel much debate and leaves policymakers questioning whether or not it assists patients in “discriminating among sites of care,” Timothy G. Ferris, MD, and David F. Torchiana, MD, wrote in a perspective in the Sept. 7 issue of the New England Journal of Medicine.   Read more...

Accumetrics has raised an additional $7 million in the first round of capital financing and has secured $24 million total in new capital.   Read more...

A five-year $11.6 million contract from the National Heart, Lung and Blood Institute for the University of Texas Health Science Center at San Antonio will focus on research pertaining to a blood test that may have the ability to diagnose MI survivors who suffer from heart failure (HF).   Read more...

Discrepancies exist between how patients and cardiologists perceive the benefits of PCI, and while many cardiologists understand the procedural benefits, many patients misjudge them and believe the procedure is used to prevent death or MI, according to a study published in the Sept. 6 edition of the Annals of Internal Medicine. The informed consent process at hospitals is laced with flaws, and should be revised, Alicia Fernandez, MD, of the University of California, San Francisco, told Cardiovascular Business News.
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Stentys has selected Stanislas Piot to serve as its new chief financial officer (CFO).   Read more...

Patients with a history of cardiovascular (CV) conditions treated with sibutramine (Meridia, Abbott Laboratories) saw an increased risk of MI and nonfatal stroke, but not CV death, according to the results of a study published Sept. 2 in New England Journal of Medicine.   Read more...

Current screening recommendations for abdominal aortic aneurysms (AAAs) fail to target some people, including women and nonsmokers, in which a large number of ruptures and deaths occur, according to a study published in the September issue of the Journal of Vascular Surgery. Use of a new high-yield screening algorithm can expand the target population for screening and help to increase the detection of AAAs, senior study author Giampaolo Greco, PhD, told Cardiovascular Business News.   Read more...

Control of atrial fibrillation (AF) was not achieved in more than 40 percent of the AF patients included in a 10,000 patient REALISE-AF registry, according to a study presented Sept. 1 at the European Society of Cardiology (ESC) congress in Stockholm.   Read more...

African-Americans may have more of a risk of developing life-threatening thrombosis after receiving drug-eluting stents (DES); however, socioeconomic status was independent of stent thrombosis, according to the results of a study published in the Aug. 31 issue of Circulation.   Read more...

The FDA has granted 510(k) clearance for the LipiScan near-infrared (NIR) and intravascular ultrasound (IVUS) coronary imaging system from InfraReDx.   Read more...

The use of a seven-day, double-dose of clopidogrel reduced cardiovascular events and stent thrombosis in patients with acute coronary syndromes undergoing PCI, but resulted in higher bleeding rates, according to a substudy of the CURRENT-OASIS 7 trial presented at the European Society of Cardiology (ESC) congress in Stockholm and simultaneously published in the Lancet.
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A low-dose regimen of unfractionalted heparin compared with standard dose did not reduce the risk of major peri-PCI bleeding or vascular access site complications in patients receiving the anticoagulant fondaparinux, which had previously been found to cut bleeding by half, according to the results of the FUTURA/OASIS-8 trial presented at the European Society of Cardiology (ESC) congress in Stockholm, and simultaneously published in the Journal of the American Medical Association.   Read more...

Aptus Endosystems has completed $15 million in Series AA financing, which will be used to advance the development of its Aptus EndoStapling system, part of the Aptus Endovascular abdominal aortic aneurysm (AAA) repair system, throughout Europe and the U.S.   Read more...

Clinical descriptors can assist clinicians in identifying high-risk patients within the range of risk for outpatients with atherothrombosis, according to a substudy of the REACH trial, presented this week at the European Society of Cardiology (ESC) conference in Stockholm, and simultaneously published in the Journal of the American Medical Association.   Read more...

Among patients with acute coronary syndromes (ACS) or atrial fibrillation (AF), the effect of clopidogrel as compared with placebo is consistent, irrespective of CYP2C19 loss-of-function carrier status, according to substudies of the CURE and the ACTIVE A trials presented this week at the European Society of Cardiology (ESC) conference in Stockholm, and simultaneously published online Aug. 29 in the New England Journal of Medicine.   Read more...

Medtronic has launched in Europe its Resolute Integrity drug-eluting stent (DES) system for the treatment of coronary artery disease, after receiving the CE mark.   Read more...

Administering low-dose supplements of n-3 fatty acids—eicosapentaenoic acid and docosahexaenoic acid or alpha-linolenic acid—did not significantly alter the rates of major cardiovascular (CV) events among MI patients, according to the results of the Alpha Omega trial presented this week at the European Society of Cardiology (ESC) meeting in Stockholm, and simultaneously published online Aug. 29 in the New England Journal of Medicine.   Read more...