News

Biotronik, CRT-D, Itrevia 7 HF-T QP, CLS algorithm, first U.S. implantations

Biotronik announced the first patients have been successfully implanted with Itrevia HF-T QP cardiac resynchronization defibrillator (CRT-D) devices. Itrevia HF-T QP includes the Closed Loop...

Boston Scientific, Safari2 pre-shaped guidewire, cath lab, TAVI, TAVR, FDA, CE

Boston Scientific announced CE Mark and U.S. Food and Drug Administration (FDA) clearance for the Safari2 Pre-Shaped Guidewire. Safari2 is an enhanced version of the  Safari Guidewire,...

FDA, gadolinium, MRI, contrast agents, GBCAs, safety, brain deposits

The U.S. Food and Drug Administration (FDA) is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI)....

ScImage, PicomWebLink, secure sharing portal, remote viewing, PACS, PICOM365

ScImage, announced the release of PicomWebLink, which provides facilities an alternative to burning unsecured CDs containing confidential patient information. The technology uses ScImage’s...

anticoagulation therapy, pulmonary embolism, Couturaud, discontinuation

Among patients with a first episode of pulmonary embolism who received six months of anticoagulant treatment, an additional 18 months of treatment with warfarin reduced the risk of additional...

GE, Aurora St. Luke's, cSound, 4-D software, cardiovascular ultrasound

Aurora St. Luke's Medical Center in Milwaukee became the first hospital in the world to implement a new 4-D cardiovascular ultrasound technology. The software allows cardiologists to see chambers...

The Medicines Company, Angiomax, generic launch, Sandoz Inc.

The Medicines Company announced an agreement July 9 with Sandoz Inc. for the distribution of an authorized generic of Angiomax (bivalirudin) for injection in the United States.

Galectin-3, Architect Galectin-3 assay, BG Medicine, Abbott, heart failure, HF

BG Medicine Inc., developer of the BGM Galectin-3 Test, announced that the Architect Galectin-3 assay is now available. This automated blood test was cleared by the United States Food and Drug...

CSI, ViperWire Advance Peripheral Guide Wire with Flex Tip, Stealth, Diamondback

Cardiovascular Systems Inc. announced that it has received U.S. Food and Drug Administration (FDA) clearance for its new ViperWire Advance Peripheral Guide Wire with Flex Tip for their peripheral...

heart failure, Adaptive CRT trial, AdaptivCRT algorithm, readmissions

Heart failure patients had a significantly lower chance of being readmitted within 30 days of discharge when treated with a cardiac resynchronization therapy device (CRT) equipped with an...

Direct Flow Medical, Transcatheter Aortic Valve System, SALUS Trial, FDA

Direct Flow Medical Inc. received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in April to broaden its SALUS Trial. The expansion includes the...

The Medicines Company, bivalirudin, Angiomax, litigation, Hospira Inc.

The Medicines Company announced the U.S. Court of Appeals for the Federal Circuit Court has ruled against the company in its bivalirudin (Angiomax) patent litigation with Hospira Inc.

HeartMate PHP, percutaneous heart pump, St. Jude Medical, Thoratec

St. Jude Medical and Thoratec announced that the boards of directors of both companies have unanimously approved a definitive agreement under which St. Jude Medical will acquire all of the...

GlobalData, TAVR, Edwards, Medtronic, CoreValve Evolut R, Sapien 3

The recent U.S. Food and Drug Administration (FDA) approvals of two next-generation transcatheter aortic valve replacements (TAVR) devices will transform the U.S. market for TAVR procedures over...

Xarelto, anticoagulant protocol, discharge, outcomes, DVT, PE

Two companion papers published in Academic Emergency Medicine  address the question of when it is appropriate to discharge patients experiencing a potentially fatal blood clot....

UNC, biomarkers, severe heart disease, fructosamine, LDL cholesterol, Nichols

Insulin resistance affects tens of millions of Americans and is a big risk factor for heart disease. Yet, some people with the condition never develop heart disease, while some experience moderate...

A new study proves race and gender-related disparities exist in care for patients who have recently been diagnosed with atrial fibrillation (AF). The study, published in the July edition of Heart...

Boston Scientific, fully absorbable scaffold, FAST study, resorbable

Boston Scientific has initiated a study of the company's first fully resorbable drug-eluting scaffold system. The Fully Absorbable Scaffold Feasibility Study (FAST) is a prospective, single-arm...

Veryan Medical, BioMimics 3D femoropopliteal stent, MIMICS-2 study, PAD

Veryan Medical announced that the first subject has been enrolled in their MIMICS-2 study at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany by the European principal investigator,...

cardiac rehab after angioplasty, rehabilitation, ACC, Randal J. Thomas, referral

Hospitals in the Midwest were more likely than others to refer patients for guideline-recommended cardiac rehabilitation following angioplasty, according to new original research. This is...