October 18, 2011 — The U.S. Food and Drug Administration (FDA) issued a proposed rule and draft special controls guidance lowering the risk classification for external pacemaker pulse generators from Class III (high-risk) to Class II (moderate-risk).
October 18, 2011 — Abbott announced the investigational Absorb bioresorbable vascular scaffold (BVS) has been recognized as the winner of the Medical Devices category in the 2011 Wall Street Journal Technology Innovation Awards. Absorb is an implantable device that restores blood flow by opening a blocked artery and providing support to the vessel until the device dissolves.
October 18, 2011 — A U.S. Food and Drug Administration (FDA) committee will discuss and make recommendations to expand Medtronic’s indication for its cardiac resynchronization therapy defibrillator (CRT-D) in Class II heart failure patients. The committee will also review a pre-market approval (PMA) application for CardioMEMS’ Heart Failure Pressure Measurement System (HF system).
Providing exceptional cardiovascular care for patients to achieve the best possible outcomes is the number one goal for ...
October 18, 2011 — Boston Scientific Corp. has begun a phased launch of its Promus Element everolimus-eluting platinum chromium coronary stent system in China. The launch campaign will be expanded within the country based upon receipt of subsequent provincial reimbursement approvals.
October 18, 2011 – New research published in the October issue of the Journal of Hospital Medicine shows hospitals accredited by The Joint Commission (JC) outperformed non-accredited hospitals on a number of nationally standardized quality measures. The measures included acute myocardial infarction (AMI), heart failure, and pneumonia. The research also shows the performance gap between JC accredited and non-accredited hospitals increased over the years of the study.
October 17, 2011 — Maquet Cardiovascular announced it has signed a three-year, dual-source contract with Premier Healthcare Alliance to provide intra-aortic balloon pumps (IABP) to the Premier membership.
Cardiac positron emission tomography (PET) is growing in popularity among cardiologists because it provides the ability ...
October 17, 2011 — New research adds to the mounting evidence that consuming chocolate seems to lower the risk of stroke; and now it appears to be more protective against certain types of stroke. Moreover, women who ate the most chocolate — 66.5 grams each week, which amounts to roughly two chocolate bars — had a 20 percent lower risk of having a stroke. The conclusions are according to a research correspondence report in the Oct. 18 issue of the Journal of the American College of Cardiology (JACC).
October 17, 2011 — The U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have established a pilot program for concurrent review of medical devices. Under the process, certain FDA premarket review submissions and CMS national coverage determinations will be simultaneously reviewed.
October 17, 2011 — The Detroit Medical Center (DMC) Cardiovascular Institute (CVI) has become the first cardiac care facility in Michigan to successfully open a patient's blocked artery with a breakthrough technology similar to an electrically powered "corkscrew drill." The technique painlessly removes the plaque buildup which causes peripheral artery disease (PAD).
When performing radiofrequency (RF) ablation to treat cardiac arrhythmia, medical professionals must balance the safety ...
October 17, 2011 — The Joint Commission and the American Heart Association/American Stroke Association (AHA/ASA) are helping organizations provide more comprehensive care for patients at certified primary stroke centers and heart failure programs nationwide.
October 17, 2011 — The U.S. Food and Drug Administration (FDA) has approved LeGoo, a gel allowing surgeons to temporarily stop blood flow during surgery. This makes it possible to join blood vessels without clamps or elastic loops.
October 17, 2011 – The number of Americans who report they have coronary heart disease – which includes heart attack and angina (chest pain) – continues to decline but rates vary widely from state to state and by race and ethnicity, according to a new report published today in the Morbidity and Mortality Weekly Report of the Centers for Disease Control and Prevention (CDC).
Change Healthcare Cardiology Hemodynamics is an integrated hemodynamic monitoring system for monitoring vital signs and ...
A U.S. Food and Drug Administration (FDA) review panel has given its unanimous recommendation for the market approval of the Zilver PTX stent. It is the first device of its kind on several fronts to go before FDA review. It is the first drug-eluting stent (DES) for peripheral leg vessels, the first self-expanding DES and the first DES that does not use a polymer to load and elute its drug.
October 14, 2011 — GE Healthcare received U.S. Food and Drug Administration (FDA) clearance of the Discovery MR750w wide bore 3.0T system with GEM (Geometry Embracing Method) suite of coils.
October 14, 2011 – CardioFocus Inc., developer of the HeartLight endoscopic ablation system (EAS) for the treatment of atrial fibrillation (AF), announced that its HeartLight EAS was used to achieve successful acute pulmonary vein (PV) isolation and restore sinus rhythm in a persistent AF patient during a live case at the Venice Arrhythmias 2011 conference, Oct. 9-12 in Venice, Italy.