News

Guardian II Hemostais Valve, recall

The U.S. Food and Drug Administration (FDA) notified healthcare professionals of a Class I recall of the Vascular Solutions Inc. Guardian II and Guardian II NC Hemostasis Valves. The firm is...

March 26, 2013 — According to two different reports from Millennium Research Group (MRG), the overall European market for peripheral vascular devices will grow strongly, reaching $1.3 billion...

NeuroVive announces that the 600th patient has been recruited to a pivotal Phase III European, multi-center clinical trial (CIRCUS trial) assessing CicloMulsion (a special formulation of...

March 26, 2013 — A multicenter analysis, led by Weill Cornell Medical College and published in the Journal of Clinical Gastroenterology, shows the use of temporary "fully covered...

Choosing Wisely ASE Echocardiogram

The American Society of Echocardiography (ASE) released a list of five interventions whose appropriateness physicians and patients should discuss as part of Choosing Wisely, an initiative of the...

March 25, 2013 — W. L. Gore & Associates introduced its Gore DrySeal Sheath with hydrophilic coating in Europe.

Abbot MitraClip

Abbott announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted by majority (Yes: 5, No: 3) that the benefits...

Cordis Corp. announced it has completed the acquisition of Flexible Stenting Solutions Inc., whose technology provides Cordis with the opportunity to evolve the S.M.A.R.T. stent platform to...

Svelte Medical Systems announced treatment of the first patient in the DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) study at Middelheim...

TherOx Inc. IDE Study Supersaturated Oxygen Therapy AMI

TherOx Inc. announced the initiation of its multicenter Investigational Device Exemption (IDE) pilot study of a second generation system that delivers supersaturated oxygen (SSO2) therapy for...

Edwards Sapien, PARTNER, 3 year followup

The three-year results of a pivotal clinical study comparing the Edwards Sapien transcatheter heart valve and open-heart surgery demonstrated comparable outcomes. These new data from The PARTNER...

Terumo Interventional Systems expanded its family of Heartrail III Coronary Guiding Catheters to include a smaller profile 5 French Ikari shape, specifically designed to provide backup support and...

ekos, pulmonary embolism, clot busting

Results of the ULTIMA trial using endovascular therapy to treat submassive pulmonary embolism (PE) were presented at the American College of Cardiology 2013 meeting, The trial is the first...

Edward Structural Heart Valve Repair Clinical Trial Sapien XT Transcatheter

Edwards Lifesciences Corporation announced that preliminary results from The PARTNER II Trial demonstrated similar one-year outcomes in mortality and major clinical events between the Edwards...

GE Healthcare DoseMap Radiation Dose Management Angiography Systems

At the American College of Cardiology (ACC) conference, GE Healthcare unveiled DoseMap to alert interventional cardiologists to patient radiation exposure during longer procedures.

For better treatment planning during cardiac resynchronization therapy (CRT), Toshiba America Medical System Inc.’s Activation Imaging is the company’s latest addition to its 3-D Wall Motion...

March 14, 2013 — Lantheus Medical Imaging Inc. announced the U.S. Food and Drug Administration (FDA) has granted approval of a supplemental new drug application (sNDA) that allows Jubilant...

March 13, 2013 — CircuLite Inc. announced it has received conditional approval from the U.S. Food and Drug Administration (FDA) for an investigational device exemption (IDE) for its lead product,...

Symplicity Renal Denervation System Medtronic Inc. Parallel Review Program

Medtronic Inc. announced the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have accepted the inclusion of the Symplicity renal denervation system...

AHA/ASA Guidelines LifeNet OnePush Stroke Treatment Device

With the recent release of the updated American Heart Association (AHA)/American Stroke Association (ASA) Guidelines for Early Management of Acute Stroke Patients, Physio-Control announced that...