News

ICD Heart Failure Treatments VAD California Boston Scientific

Three weeks after delivering her first child, Amanda began to suffer from extreme fatigue, headaches, a tight chest and stomach pain. An initial diagnosis of pneumonia changed for the worse:...

Interim results from The Chocolate Bar Registry conducted in the United States demonstrate that use of the Chocolate PTA balloon achieved high rates of treatment success and limb preservation in...

Corevalve, FDA, Edwards, TAVR, TAVI, lawsuit, injunction

The Federal Circuit Court of Appeals granted a request from Medtronic Inc. to postpone the implementation of an injunction that would have prevented the company from selling its CoreValve System...

FDA Clearnace Volcano Corp. iFR Modality FFR Catheter Cath Lab

Volcano Corp. announced U.S. Food and Drug Administration (FDA) clearance of its proprietary Instant Wave-Free Ratio (iFR) modality.

April 21, 2014 — Cardiologists and cancer experts at the Mount Sinai Hospital in Manhattan have joined forces to establish its first cardio-oncology clinic at the Tisch Cancer...

Treatment options for high-risk heart patients with severely calcified coronary artery disease (CAD) have been limited for more than 20 years. Now, Robert Wood Johnson University Hospital (RWJUH)...

Tendyne Holdings Inc. has secured $25 million in an oversubscribed Series C financing led by Apple Tree Partners, along with Boulle Group members and other existing investors. 

April 18, 2014 — New research presented at the 34th annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) demonstrated the CorMatrix particulate extracellular...

April 18, 2014 — A University of California, San Diego scientist has developed a new biomaterial that could potentially treat heart attacks. Karen Christman, Ph.D., associate professor of...

The webinar will focus on implementation of different strategies to help clinicians reduce radiation exposure during interventional cardiology procedures, both for patient and operators. It will...

April 16, 2014 — Covidien announced it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline embolization device and Alligator retrieval device, where...

April 16, 2014 — Abbott announced it has completed enrollment of three clinical trials to support approvals of the company's Absorb bioresorbable vascular scaffold (BVS) in the United States,...

IN.PACT Drug-eluting Balloon Angioplasty IN.PACT SFA Clinical Trial

Patients with peripheral artery disease in the upper leg experienced significantly better outcomes at 12 months after treatment with the IN.PACT Admiral drug-coated balloon from Medtronic Inc....

Corevalve beats surgery, ACC 2014, TAVR vs surgery, Edwards lawsuit

The U.S. District Court for the District of Delaware granted a preliminary injunction limiting the sale of Medtronic's CoreValve transcatheter aortic valve replacement (TAVR) system in the United...

April 14, 2014 — CardiacAssist announced it has received a Class 4 medical device license for its TandemHeart system from Health Canada. The TandemHeart system is now licensed to provide up to 10...

 Mitralign Inc. has completed enrollment in a study in Europe investigating its lead device, the Mitralign System, in patients with functional mitral regurgitation (FMR).

April 10, 2014 — The largest single-center study of patients implanted with a total artificial heart found the device may help patients in severe heart failure survive until they can receive a...

Cardiac Ultrasound Blood Clots Heart Brain ACC.14

A study with a new ultrasonic scanning technique shows that scanning of the carotid arteries can reveal who is at high risk of being hit by a blood clot. 

Cardinal Health AccessClosure Acquisition Vascular Closure Devices Cath Lab

Cardinal Health announced an agreement to acquire privately held AccessClosure Inc. for $320 million. 

SCAI ACC.14 Choosing Wisely Campaign Tests Treatments to Avoid Cath Lab

The Society for Cardiovascular Angiography & Interventions (SCAI) issued a list of five specific, evidence-based recommendations that should be avoided in the care of patients who have, or are...

Philips Healthcare presented new imaging and informatics solutions at the American College of Cardiology Conference (ACC) Annual Meeting. 

GE Healthcare showcased a new suite of connected cardiovascular technologies, including several for advanced imaging and new software capabilities, at ACC 2014. New innovations included advances...

Merge, CVIS, cardiac PACS

Patients do not have to be the only beneficiaries of technological innovation. Indeed, many technological hardware and software solutions are emerging to help cardiac care providers negotiate...

In a comparison of two blood-thinning medications, heparin was associated with significantly fewer major cardiovascular events at 28 days than bivalirudin in patients receiving primary...

Epsilon Imaging EchoInsight Cardio Oncology Echo Cardiac Ultrasound

Epsilon Imaging Inc. has expanded its EchoInsight automated measurement suite for improved analysis and interpretation in echo.

April 7, 2014 — A first-ever randomized head-to-head comparison of two devices commonly used to treat aortic stenosis finds balloon-expandable transcatheter valves (such as the Edwards Sapien)...

Medtronic, SYMPLICITY, SYMPLICITY HTN-3 trial, renal denervation, ACC.14

A major disappointment earlier this year was the announcement by Medtronic that its renal denervation system failed to meet its primary endpoint for efficacy in the U.S. SYMPLICITY HTN-3 trial....

Iodixanol Iopamidol Contrast Media Peripheral Arteriography ACC.14 Clinical Stud

GE Healthcare announced results from a new clinical study, which showed that patients receiving iodixanol (Visipaque) 320mg I/ml reported less discomfort, characterized by heat or cold sensation...

Biolimus Everolimus Stent Clinical Trial ACC.14

A new stent covered with biodegradable coating continues to show statistical equivalence to Japan’s market leader in cumulative second-year data and subgroup analyses, according to research from...

Corevalve beats surgery, ACC 2014, TAVR vs surgery

The key trial presented at the 2014 American College of Cardiology (ACC) that will likely be the one attendees will remember “they were there for” in the years to come was data showing...

April 2, 2014 — At the 63rd annual scientific session of the American College of Cardiology (ACC), Esaote premiered its new CrystaLine imaging technology that improves ultrasound’s diagnostic...

Acist RXi Rapid Exchange FFR System April 2014 ACC.14

Acist Medical Systems Inc. announced at the American College of Cardiology's 63rd Annual Scientific Session in Washington, D.C., the global introduction of the new Acist|RXi Rapid Exchange...

April 1, 2014 — Citing accelerating healthcare costs and finite resources, the American College of Cardiology (ACC) and the American Heart Association (AHA) announced they will begin incorporating...

April 1, 2014 — Medtronic Inc. announced the one-year results of the Melody transcatheter pulmonary valve (TPV) U.S. post-approval study, which found that real-world use of the Melody TPV was...

AccessClosure Next-Generation Vascular Closure Device ACC.14 March 2014

AccessClosure Inc. commercially launched itsMynx Ace vascular closure device, a safe and secure vascular closure product that provides consistent results with a new, easy-to-use deployment system...

FDA Abbott Supera Self-Expanding Stent Peripheral Artery Disease

The U.S. Food and Drug Administration (FDA) approved Abbott’s Supera Peripheral Stent System to treat people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD...

March 31, 2014 — BioCardia Inc. announced it received CE mark for its Morph AccessPro steerable introducer, designed for easier navigation through the vasculature during delivery of...

March 31, 2014 — Led by members of the American College of Cardiology (ACC), American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI), 14 professional...

Terumo Corp. Arterial Remodeling Technologies Bioresorbable Coronary Stent

Privately held Arterial Remodeling Technologies (ART) signed a structured buyout agreement with Terumo Corp. Under the agreement, ART and Terumo Corp. will collaborate in the development of a drug...

At the 63rd Annual Scientific Session of the American College of Cardiology (ACC), March 29-31 at the Walter E. Washington Convention Center in Washington, D.C., Siemens Healthcare will deliver...

CBSET Renal Denervation Hypertension Therapies Symplicity-3 Trial

Scientists at CBSET are reminding thought leaders in renal denervation that there is a seminal experimental and computational template for the more rational, comprehensive preclinical evaluation...

Trinias, Shimadzu, angiography systems

The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for three new digital angiography systems...

InspireMD Inc. has enrolled the first patient into the CARENET (CARotid Embolic protection study using microNET) multi-center European...

AccessClosure Mynx Ace Vascular Closure Device Hemostasis Management Cath Lab

AccessClosure plans to launch the Mynx Ace Vascular Closure Device at the 2014 American College of Cardiology meeting, March 29-31. It is an upgrade of the company’s Mynx mechanical ...

Surgeons in France have successfully replaced the aortic valve in two patients without opening the chest during surgery....

PVAD, percutaneous VAD, hemodynamic support, aortix

Percutaneous ventricular assist (pVAD) devices offer more hemodynamic support than the 40-year-old gold standard of intra-aortic balloon pumps (IABPs), but their cost and...

I have watched a trend in medical technology grow from a small ripple a couple years ago into what I expect will be a tidal wave in 2014 due to growing concern over patient radiation dose levels...

Thoratec HeartMate II LVAS Pocket System Controller Heart Failure Devices VAD

Thoratec Corp. initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II LVAS Pocket System Controller. The following...

The increasing number of percutaneous coronary interventions (PCIs) being performed at low-volume centers without on-site cardiac surgery backup has driven the need for new safety and quality...

Cath Lab Clinical Trial Study Cardiovascular Surgery

National Institutes of Health researchers have identified a biological pathway that contributes to the high rate of vein graft failure following ...

Boston Scientific Rebel Platinum Chromium Coronary Stent System Bare Metal

Boston Scientific Corp. received CE marking for the Rebel Platinum Chromium Coronary Stent System, the company's latest generation ...

Privately held On-X Life Technologies Inc. (On-X LTI) launched its European marketing campaign for the On-X Plus 1.5 Aortic Heart Valve in concert with its Great Britain distributor Vascutek Corp...

Corindus CorPath Robotic Navigation Telemedicine Telecardiology Cath Lab

For patients living in rural areas, life-saving procedures such as an angioplasty may only be available at a facility more than 200 miles away. To bridge this distance, ...

The U.S. Food and Drug Administration (FDA) cleared Cardiovascular Systems Inc.’s Diamondback 360 60 cm Peripheral Orbital Atherectomy Systems (OAS) for the treatment of peripheral arterial...

ImaCor ClariTEE Zura EVO hTEE Ultrasound transesophageal TEE Cardiac

ImaCor Inc., the developer of hemodynamic transesophageal echocardiography (hTEE) technology, announced four...

Society of Interventional Radiology SIR Deep Vein Thrombosis DVT PTS Venous

Deep vein thrombosis (DVT) often brings with it the risk of post-thrombotic syndrome (PTS), an under-recognized but...

Spectranetics Excite ISR Atherectomy Systems Cath Lab Clinical Trial Study

The Spectranetics Corp. announced that the Excite ISR trial achieved the statistical endpoints of the adjunct analysis...

Radial Access Interventional Radiology Fibroids

Interventional radiologists have devised a way to access a woman's fibroids by ...

Quail Digital Communications Wireless Headsets Cath Lab EP Lab

Memorial Hospital in Carbondale, Ill., has chosen Quail Digital’s healthcare wireless headset system. It will be used in ...

Infraredx Inc. TVC Imaging System Intravascular Ultrasound IVUS Clinical Study

MedStar Heart Institute of Washington, D.C., and Infraredx Inc. enrolled the first participant in the Lipid-Rich Plaque (LRP) Study. The LRP Study is a prospective,...

Edwards Lifesciences Fortis Mitral Transcatheter Valve System Heart Valve Repair

Edwards Lifesciences Corp. announced the successful completion of the first three human implants of its Fortis mitral transcatheter ...

Gore Excluder AAA Stent Graft

W. L. Gore & Associates’ Gore Excluder Iliac Branch Endoprosthesis is a complete, fully engineered system intended for endovascular treatment of common iliac artery aneurysms or aortoiliac...

Drug-eluting Balloon Angioplasty Clinical Study Trial Diabetes Restenosis

Despite good immediate results, in up to 40 percent of patients, obstructed arteries in the leg treated with a stent will again become blocked. This in-stent restenosis is typically treated with...

TAVR Heart valve repair Hybrid OR Edwards Lifesciences Sapien

At age 88, Lena M. Smith visited her doctor, Larry Hunt, M.D., at the University of Alabama at Birmingham to find out why her energy level had diminished. 

Boston Scientific Lotus Aortic Valve Repair Heart Hybrid OR Cath Lab

Boston Scientific’s Lotus transcatheter aortic valve repair (TAVR) system was implanted for the first...

Carotid Artery MRI Systems Clinical Study Trial Cath Lab Cardiac Diagnostics

Noninvasive imaging of carotid artery plaque with magnetic resonance imaging (MRI) can accurately predict future...

March 5, 2014 — Esaote has launched CrystaLine, a significant evolution of its ultrasound technology that delivers new levels of accuracy, quality, versatility and value. Esaote...

March 4, 2014 — The U.S. Food and Drug Administration (FDA) has sent out a Class 1 recall notice regarding various convenience kits containing Acme Monaco Guidewire .035x150 3 MMJ TCFC, item...

March 3, 2014 — Biotronik announced the release of its Passeo-18 Lux drug-releasing balloon (DRB) in all countries...

March 3, 2014 — OrbusNeich announced that patient enrollment has initiated in Japan in the pivotal clinical trial of the Combo dual-therapy stent, employing a single Japan-U.S. protocol conducted...

Evena Eyes-On Glasses Cath Lab Hybrid OR Vascular Access

Evena Medical, a developer of high-definition imaging for precision venous access, announced an agreement with a...

Cordis Trieme Chocolate PTA Balloon Catheter Peripheral Artery Disease PAD

Cordis Corp. announced an agreement with TriReme Medical Inc. that grants the company exclusive distribution rights for the Chocolate PTA Balloon Catheter. 

CT Systems Cardiac Ultrasound MRI Nuclear Imaging

Determining the appropriate use of cardiovascular imaging requires analyzing the “complex interplay” among care...

February 28, 2014 — Mercator MedSystems released pilot study data from a single-arm, open label study of 20 patients suffering with peripheral artery disease (PAD), which reveal sustained,...

IMRIS Visius Surgical Theatre MRI Systems Angiography Hybrid OR

The U.S. Food and Drug Administration (FDA) cleared IMRIS Inc.’s upgraded Visius Surgical Theatre, which integrates Siemens' high-field MR scanners. The core imaging technology based on Siemens...