News

Researchers have announced the results of a study which shows that among patients readmitted for congestive heart failure (CHF), a high E/e’ (a measure of elevated left ventricle filling...

Researchers have announced the results of a clinical study that shows a key difference in the patient’s baseline heart size and function following transcatheter valve replacement (TAVR) that may...

Philips Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its AlluraClarity live image guidance system in the United States.

FDA US device innovation

With recent medical device advances have come increasing concerns about the ability of the United States to remain at the forefront of research, especially in light of stringent FDA policies...

cath lab, SYNTAX, SCAI

The year 2013 has brought us several important clinical trials that have changed the way interventional cardiologists approach and treat patients with stable coronary artery disease. These trials...

One-year data from an Italian multicenter randomized controlled trial of the In.Pact Falcon drug-eluting balloon from Medtronic Inc. demonstrate positive and durable clinical results with the...

More than 54 companies will display their latest products and services at the American Society of Echocardiography’s (ASE) 24th Annual Scientific Sessions, planned for June 29-July 2 at...

June 25, 2013 — Zoll Medical Corp. announced that a paper published in Critical Care Medicine reported the likelihood of achieving a return of spontaneous circulation (ROSC)...

June 25, 2013 — Cordis Corp. announced the European CE marking and U.S. Food and Drug Administration (FDA) approval of additional sizes of its Sleek OTW (over-the-wire) platform, a 0.014-inch...

Aptus Endosystems Inc. Heli-FX 28 mm wide neck abdominal aortic aneurysms

Aptus Endosystems Inc. announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 28 mm Tip Reach Heli-FX Guide. A line extension of the original Heli-FX...

Cardiovascular Systems Inc. orbital atherectomy system LIBERTY 360°clinical tria

Cardiovascular Systems Inc. (CSI) announced that the first patient has been enrolled in its post-market clinical study...

Biosensors International Group Ltd. has entered into a licensing agreement with Eurocor GmbH, a group company of Opto Circuits (India) Ltd. for their drug eluting balloon (DEB) technology and...

Valtech Cardio Heart Valve Repair Cardioband Annuloplasty Ring

Valtech Cardio Ltd. announced that two patients diagnosed with severe mitral regurgitation (MR) have been treated successfully with its Transfemoral Cardioband Annuloplasty System.

ACC AHA SCAI Update Clinical Competencies for Quality PCI

Criteria for evaluating operator competency for performing coronary interventions should be expanded beyond procedure volume and include an evaluation of risk-adjusted outcomes, periodic case...

Preliminary results from the ADVISE (Adenosine Vasodilator Independent Stenosis Evaluation) II trial confirm prior retrospective publications and demonstrate the clinical usefulness of an iFR/...

St. Jude Medical Inc. announced U.S. Food and Drug Administration (FDA) approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN Multi-Electrode Renal...

Abbott has announced publication of positive outcomes from two European post-approval studies of the catheter-based MitraClip therapy for the treatment of mitral regurgitation (MR). Results...

Tryton Side Branch Stent Nordic-Baltic Bifurcation Study Group Clinical Trial

Tryton Medical Inc. announced that the Nordic-Baltic Bifurcation Study Group will investigate the Tryton Side Branch Stent. The trial is a prospective, controlled, randomized, multicenter clinical...

New long-term data from the DIVERGE study, presented at EuroPCR 2013 by Principal Investigator Dr. Stefan Verheye, Antwerp Cardiovascular Centre, ZNA Middelheim Hospital, Belgium, has shown that...

Direct Flow Medical Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin the SALUS feasibility...