News

April 17, 2014 — Medtronic announced the U.S. Food and Drug Administration (FDA) approved an expanded indication for biventricular (BiV) pacing with Medtronic cardiac resynchronization therapy-...

Biotronik Iforia ICD ProMRI Clinical Trail U.S.

Biotronik announced that the first patients across the United States have received implants of the new Iforia implantable cardioverter-defibrillators (ICDs).

April 15, 2014 — The Spectranetics Corp. announced U.S. Food and Drug Administration (FDA) clearance of two new mechanical lead extraction platforms that expand physicians' options for the safe...

April 14, 2014 — Biotronik recently announced CE approval for its new Eluna pacemaker series. The new generation of pacemakers includes single- and dual-chamber as well as cardiac...

April 11, 2014 — Medtronic announced CE mark and European launch of the Evera MRI SureScan implantable cardioverter-defibrillator (ICD) system, the first and only ICD system approved for...

April 11, 2014 — Boston Scientific Corp. has expanded the launch of its S-ICD (subcutaneous implantable cardioverter-defibrillator) system into parts of Asia. The first implant of the S-ICD...

Cardiologists at Arnold Palmer Hospital for Children performed Florida’s first pediatric implant of a new device to prevent sudden cardiac arrest.

April 10, 2014 — The 2014 Guideline for the Management of Patients With Atrial Fibrillation includes recommendations for an increased use of radio frequency (RF) ablation in the treatment of non-...

Cardinal Health AccessClosure Acquisition Vascular Closure Devices Cath Lab

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

ICD, MADIT-CRT trial, long-term followup, ACC.14

Patients in mild heart failure who receive a cardiac resynchronization therapy defibrillator (CRT-D) device may live longer than those implanted with a traditional implantable...

I had become accustomed to making the necessary tradeoffs when choosing the appropriate defibrillator for my patients and until recently thought that these choices were ones that I would always...

April 3, 2014 — The new app-driven Seer 1000 Holter recorder from GE Healthcare utilizes new technology to simplify Holter monitor management.

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...

March 31, 2014 — Biotronik announced new results from a sub-analysis of the TRUST trial, published in the European Heart Journal. This analysis examined recommended ICD (implantable...

eCardio Diagnostics will highlight its expertise for integrating its services with customers' existing electronic medical records (EMR) systems at upcoming conferences.

St. Jude Medical Optisure Defibrillation Lead

St. Jude Medical Inc. announced the global launch of the Optisure defibrillation lead.

defibrillator, heart study

Medtronic, Inc. announced the first patients were enrolled in the Improve SCA Clinical Study, a first-of-its-kind study that will identify patients in developing countries at high risk for sudden...

St. Jude Medical Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P), which...

biotronik, MRI safe ICD

Biotronik has announced the Food and Drug Administration (FDA) has approved the expansion of Biotronik’s ongoing ProMRI clinical trial. The new phase of the trial (Phase C) will study...

BioTelemetry Inc. entered into a definitive agreement to acquire the cardiac patient services business of Biomedical Systems Corp. (BMS) for aggregate consideration of $8.65 million at closing.

Sorin Group has purchased Oscor Inc. lead business, including a lead manufacturing facility in the Dominican Republic for a value of approximately $20 million.

atrial fibrillation, LARIAT

Doctors at the Stony Brook Heart Institute Electrophysiology Lab are using a new nonsurgical technique called the Lariat Suture Delivery Device to treat patients with atrial fibrillation who...

Boston Scientific Ingevity Leads MRI Systems Pacemakers CRT EP Lab

Boston Scientific Corp. received CE marking and launched in Europe the Ingevity family of magnetic resonance imaging...

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 ...

St. Jude Medical Nanostim Leadless Pacemaker EP Lab Clinical Trial

St. Jude Medical Inc. announced the first enrollments in the company’s LEADLESS Pacemaker Observational Study ...

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, ...

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 ...

Medtronic Reveal Linq Insertable Cardiac Monitor Implantable ECG Wireless EP Lab

The Valley Hospital is among a few hospitals in the nation to implant a tiny wireless heart monitor expected to...

Biotronik Home Monitoring CRT Leads, Implantable Devices EP Lab

Biotronik announced the first implantations of the Sentus ProMRI lead. Biotronik’s bipolar cardiac resynchronization therapy (CRT) lead is the first MR conditional lead with a 4 French...

Medtronic SureSan EP Lab Pacemaker MRI Systems Pacing Revo Advisa

The Medtronic SureScan pacing systems are now approved for MRI scans positioned on any region of the body....

Medtronic Scripps Reveal Linq Insertable Cardiac Monitor ICM EP Lab ECG Remote

Scripps Green Hospital has become the first hospital in the United States to implant the world's smallest implantable cardiac monitoring device. Scripps Clinic cardiologist John Rogers, M.D.,...

Biosense Webster Thermocool Smarttouch Catheter Atrial Fibrillation Ablation EP

The U.S. Food and Drug Administration (FDA) approved Biosense Webster Inc.’s Thermocool Smarttouch Catheter. The therapeutic catheter enables direct and real-time measurement of contact force...

February 28, 2014 — Igor Efimov, Ph.D., from the School of Engineering & Applied Science at Washington University in St. Louis, and an international team of biomedical engineers and materials...

Approximately one in two patients with atrial fibrillation (Afib) do not optimally reduce their risk of stroke...

Ablation Systems Balloon Atrial Fibrillation Therapies EP Lab Apama Shifamed

Apama Medical is a privately held medical device company formed by Shifamed's medical incubator. It received Chinese notice of allowance for claims covering their low profile electrode assembly...

Medtronic Reveal Linq Insertable Cardiac Monitor Implantable Holter ECG Wireless

Medtronic Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance, CE marking and the global launch of its Reveal Linq Insertable Cardiac Monitor (ICM) System. Medtronic...

Medtronic Micra Transcatheter Pacing System TPS EP Lab Clinical Trial Study

Medtronic Inc. announced the first U.S. implant of the Micra Transcatheter Pacing System (TPS). The device was successfully implanted at NYU Langone Medical Center by Larry Chinitz, M.D., director...

St. Jude Medical Nanostim Leadless Pacemaker EP Lab Clinical Trial

St. Jude Medical selected Dignity Health Sequoia Hospital's Heart and Vascular Institute and Silicon Valley Cardiology to participate in a ...

LAPTOP-HF Telecardiology Remote Patient Monitoring ICM EP Lab Heart Failure ECG

A new treatment option for heart disease is being tested at The University of Kansas Hospital that could be...

AliveCor Heart Monitor FDA EP Lab ECG Cardiac Diagnostics Mobile Remote

The U.S. Food and Drug Administration (FDA) granted AliveCor Inc. over-the-counter (OTC) clearance for the AliveCor Heart Monitor, a single-channel ...

Biotronik, a manufacturer of implantable cardiac devices and wireless remote monitoring technologies, has been...

Vascular Solutions ThrombiDisc Topical Hemostat Introducer Sheaths Cath Lab

Vascular Solutions Inc. launched the ThrombiDisc topical hemostat designed for use around...

DECAFF MRI Atrial Fibrillation Therapies Ablation Systems EP Lab Clinical Study

A University of Utah-led study for treatment of patients with atrial fibrillation (A-fib) provides strong...

eCardio Diagnostics is opening its second Independent Diagnostic Testing Facility (IDTF) in San...

American College of Cardiology Clinical Trial Cath Lab EP Cardiac Diagnostics

Results from several late breaking clinical trials will be presented during  the American College of...

St. Jude Medical Nanostim Leadless Pacemaker EP Lab

The first U.S. implant was announced for St. Jude Medical’s LEADLESS II pivotal trial, designed to evaluate the...

therapeutic hypothermia, Philips InnerCool

Use of therapeutic hypothermia is used to prevent neurological damage in patients who suffer sudden cardiac arrest (SCA), and there are many advocates suggesting a similar approach can...

Biotronik ProMRI Clinical Study Pacemaker EP Lab Magnetic Resonance Imaging

Biotronik enrolled the first patients in an expansion of their ongoing ProMRI trial to test its ...

Pressure Products SafeSept Needle Free Transseptal Guidewire EP Cath Lab

The U.S. Food and Drug Administration (FDA) approved Pressure Products Inc.’s SafeSept Needle Free Transseptal ...

St. Jude Medical Nanostim Leadless Pacemaker EP Lab

Prof. Richard Schilling implanted St. Jude Medical Inc.’s Nanostim retrievable leadless pacemaker at St....

Biotronik Home Monitoring Remote Monitoring Systems ECG Wireless EP Lab

An Effectiveness and Cost of ICD Follow-Up Schedule with Telecardiology (ECOST) study indicated the Biotronik Home Monitoring may reduce follow-up costs in patients with implantable...

FDA Premarket Approval PMA Clinical Study EP Lab Cath Leads Implantable Devices

The U.S. Food and Drug Administration (FDA) has approved many cardiac implantable electronic device...

Irvine Biomedical Therapy Cool Flex Ablation Catheter St. Jude Medical

The U.S. Food and Drug Administration (FDA) gave market clearance to Irvine Biomedical Inc., a St. Jude Medical company, for its Therapy Cool Flex Ablation Catheter and IBI 1500T9-CP v.1.7 Cardiac...

The Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) 2013 offers many new insights about the latest cardiovascular technologies and treatment techniques. These...

boston scientific s-icd implantable cardioverter defibrillator ICD ep lab

A new internal defibrillator that treats patients with major heart risks, is...

A clinical trial found that Xa inhibitor edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin for the prevention of stroke or systemic embolic events (SEE) in...

topera 3-d 3d mapping system firmap rhythmview EP lab mapping fibrillation

Topera Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for the latest generation of its 3D Mapping System.

clinical trial study irhythm holter monitors zio report patch ecg ep lab

iRhythm Technologies announced that a prospective study by Scripps Translational Science Institute (STSI) has found that use of...

ACC, iPad cardiology apps

DAIC readers chose the following stories as the most popular content in 2013, based on website analytics.

Boston scientific autogen x4 crt-d crt ICD heart failure cardiac

Boston Scientific Corp. has received CE mark approval of its X4 line of quadripolar ...

AtriCure Inc., an atrial fibrillation (AF) medical device provider, and Endoscopic Technologies Inc, doing...

Atrial fibrillation (AF), long considered the most common condition leading to an irregular heartbeat, is a growing and...

CSL Behring announced that Kcentra (Prothrombin Complex Concentrate [Human]) has received U.S. Food and Drug Administration (FDA) approval for an expanded indication — urgent reversal of acquired...

Watchman, LAA occluder, atrial fibrillation

The U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably Dec. 11 in a 13-1 vote that the benefits of the Watchman...

rhinochill, RhinoChill, benechill, BeneChill

With the benefits of conventional strategies for therapeutic hypothermia following cardiac arrest being called in to question following the publication of two new studies, brain...

topera 3-d ep lab atrial fibrillation therapies mapping/imaging systems

Topera Inc. shared the results of an independent evaluation of its diagnostic system’s ability to improve atrial...

Combining genetic data with clinical information to determine the initial dosage of the blood thinner warfarin, used to prevent blood clots in the circulatory system, was no more effective in...

cd leycom inca blood pressure monitor cardiac diagnostics ep lab heart failure

Millar Inc. and CD Leycom announced the appointment of Millar as the exclusive U.S. distributor of CD Leycom’s clinical Inca in pressure-volume (PV) loop system and disposable clinical PV loop...

clinical trial study cath lab ep heart failure treatments cardiofit biocontrol

A multidisciplinary team of experts in heart failure, cardiac arrhythmia and neurosurgery at Mount Sinai Hospital in New York City are testing nerve stimulation in the neck as a therapy for heart...

laa occluders structural heart atrial fibrillation atricure atriclip exclusion

AtriCure Inc., a developer of solutions to treat atrial fibrillation, announced the U.S. Food and Drug Administration’s (FDA’s) approval to begin enrollment in a clinical study of AtriCure’s...

nanostim pacemaker, SJM

The tiny device, about the size of the head of a pen, can be delivered via a delivery catheter through the venous system and placed directly into the myocardium of the right ventricle. 

cardiac diagnostics clinical trial s tudy atrial fibrillation therapies ep lab

Doctors have known for years that atrial fibrillation (AF) increases the risk for stroke, but now researchers...

cath lab navigation aids robotic systems corindus tct corpath

Corindus Vascular Robotics presented a live percutaneous coronary intervention (PCI) during the Transcatheter...

catheters cath lab ep laa occluders baylis medical torflex transseptal sheath

The U.S. Food and Drug Administration (FDA) announced a Class I recall of Baylis Medical’s TorFlex Transseptal Guiding Sheath Kit device designed for ...

LAA occluder, Watchman

According to Millennium Research Group (MRG), the anticipated Food and Drug Administration (FDA) approval of Boston Scientific's Watchman device will drive rapid growth in the market for...