BioSpace.com News

CardioComm Solutions Inc. Announces September Launch of the HeartCheck™ PEN and SMART Monitoring Service

Wed, 05 Sep 2012 12:00:00 AM GMT

TORONTO--(BUSINESS WIRE)--CardioComm Solutions, Inc. (TSX VENTURE:EKG) (CardioComm Solutions or the Company) today announced a three year Enterprise Cloud Services (ECS) agreement with SunGard Availability Services (Canada) Ltd, a subsidiary of SunGard Data Systems Inc. (SunGard). The ECS will give CardioComm Solutions the systems infrastructure to launch the HeartCheckTM SMART Monitoring services...

Medtronic, Inc. Expands Availability of Valiant(R) Captivia(R) Stent Graft in Major Global Markets

Wed, 09 May 2012 12:00:00 AM GMT

MINNEAPOLIS--(BUSINESS WIRE)--Increasing patient access to endovascular repair of aortic aneurysms worldwide, Medtronic, Inc. (NYSE: MDT) is expanding availability of the Valiant Captivia Thoracic Stent Graft System in several countries, including China, Japan and the United States.

Journal of Endovascular Therapy: New Balloon Catheter System Shows Promise to Advance Endovascular Technique

Wed, 02 May 2012 12:00:00 AM GMT

May 5, 2012 -- Journal of Endovascular Therapy A new balloon catheter system could advance the endovascular approach to treating obstructed arteries in the leg, offering an alternative to surgical revascularization. Peripheral artery disease affects about 12 to 14 percent of the general population, and revascularization can be achieved through bypass surgery or a number of minimally invasive endovascular...

Defibtech Introduces TSO-Authorized Aviation Battery for Lifeline??? VIEW AED

Wed, 25 Apr 2012 12:00:00 AM GMT

GUILFORD, Conn.--(BUSINESS WIRE)--Defibtech today introduced the TSO-C142a-authorized aviation battery for the Lifeline VIEW automated external defibrillator (AED). Following rigorous testing, the aviation battery passed the aircraft industrys required safety and performance standards. The long-life battery provides for eight hours of continuous operation to monitor and document a patients ECG during...

St. Jude Medical Cites Insulation Snag in Wires, Shares Fall

Thu, 05 Apr 2012 12:00:00 AM GMT

St. Jude Medical Inc on Wednesday halted sales of two brands of lead wires used in its cardiac resynchronization therapy (CRT) devices due to worn insulation, following similar problems with another type of lead wire recently. No patient injuries or product failures have been reported as a result of the latest insulation problem, which involves its QuickSite and QuickFlex left ventricular leads used...

St. Jude Medical to Stop Selling Another Version of Defibrillator Wires

Wed, 04 Apr 2012 12:00:00 AM GMT

ST. PAUL, Minn., Apr 04, 2012 (BUSINESS WIRE) -- St. Jude Medical, Inc., a global medical device company, today announced it is proactively informing physicians about visual observations of externalized conductors on the silicone end of QuickSite and QuickFlex Left-Ventricular (LV) Leads, used to connect Cardiac Resynchronization Therapy (CRT) devices to the heart.

There have been no reports...

Blue Medical's Drug Eluting Balloons Fly High

Wed, 28 Mar 2012 12:00:00 AM GMT

LONDON, UK (GlobalData), 28 March 2012 - Blue Medical, a company focused on the treatment of cardiovascular diseases, announced last week the launch of their CE approved drug eluting balloon (DEB) Protg. This marks another entry into a new and exciting market within the interventional cardiology industry. Current players with CE approval in the DEB market include B.Braun, Eurocar and Invatec....

Edwards Lifesciences Sapien Safely Replaces Aortic Valves at Two Years

Mon, 26 Mar 2012 12:00:00 AM GMT

CHICAGO, IL--(Marketwire - March 26, 2012) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, reported that longer-term results ( ≥ 2 years) from the high-risk Cohort A of The PARTNER Trial -- a randomized comparison of patients...

Medtronic, Inc. Resolute?? Drug-Eluting Stent Delivers Durable Clinical Outcomes Through Two Years in Major Studies

Mon, 26 Mar 2012 12:00:00 AM GMT

CHICAGO--(BUSINESS WIRE)-- According to new clinical data presented today at ACC.12 the 61st Annual Scientific Session & Expo of the American College of Cardiology (ACC) the Resolute drug-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT - News) maintains a powerful and persistent treatment effect for a wide variety of patients with coronary artery disease, including those with diabetes mellitus...

GE Healthcare Unveils First Intelligent Motion Correction for High Heart Rate Cardiac CT

Mon, 26 Mar 2012 12:00:00 AM GMT

CHICAGO--(BUSINESS WIRE)--Announcing a leap forward in advanced cardiac imaging, GE Healthcare introduces the FDA 510(k)-pending Discovery CT750 HD FREEdom Edition at the opening of this years American College of Cardiology (ACC) Annual Scientific Session & Expo in Chicago. Addressing the main challenges of cardiac imaging coronary motion, high heart rates, calcium blooming, plaque composition...

St. Jude Medical Announces Next-Generation PressureWire for FFR Measurement

Fri, 23 Mar 2012 12:00:00 AM GMT

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) clearance for multiple enhancements to its PressureWire Fractional Flow Reserve (FFR) measurement guidewire. FFR measurement identifies the severity of narrowings in the coronary arteries and allows for a more effective assessment...

GE Healthcare Centricity Cardio Enterprise Unveiled at American College of Cardiology 2012

Thu, 22 Mar 2012 12:00:00 AM GMT

CHICAGO--(BUSINESS WIRE)--At the 61st Meeting of the American College of Cardiology in Chicago next week, GE Healthcare is introducing Centricity* Cardio Enterprise, a new and comprehensive IT solution that offers cardiologists a single point of access to patient data, images and reports across the continuum of care while enhancing physician productivity and improving charge capture accuracy. Centricity...

Stryker Corporation Stent May Not be Worth the Risks of Stroke, FDA Staff Report Says

Wed, 21 Mar 2012 12:00:00 AM GMT

Stryker Corp. (SYK)s Wingspan stent may not be worth the risks because the device has no added benefit over drugs used to prevent stroke in patients with narrowed arteries in the brain, U.S. regulators said today. The brain stent may be inferior in some cases than standard therapy for stroke prevention, including blood thinners, Food and Drug Administration staff wrote in a report today. The agency...

Atherotech Diagnostics Lab Release: VAP?? Cholesterol Test Helps Researchers Study Dyslipidemia, Assess Effectiveness of New Anti-flushing Agent

Thu, 15 Mar 2012 12:00:00 AM GMT

BIRMINGHAM, Ala.--(BUSINESS WIRE)--Researchers using the VAP Cholesterol Test to isolate lipid subfractions and assess a new anti-flushing agent report significant baseline reductions in the cholesterol content of lipoproteins across the entire VLDL to LDL density range in dyslipidemic patients.

PREE Corporation???s Heartfelt is the Only Baby Monitor that Displays an Infant???s Breathing and Heart Rate

Fri, 24 Feb 2012 12:00:00 AM GMT

SAN ANTONIO--(BUSINESS WIRE)--PREE Corporations Heartfelt Infant Vitals and Video Monitoring System is a revolutionary product that will provide parents with the peace of mind knowing their baby is sleeping soundly. Knowing your infants heart and breathing rate is a vital component of the Heartfelt system, stated CEO Rudy W. De La Garza. With video parents can only see an image of their baby...

Teleflex Incorporated Signs New Agreement with for Arrow Intra-Aortic Balloon Pumps and Catheters

Tue, 21 Feb 2012 12:00:00 AM GMT

LIMERICK, Pa.--(BUSINESS WIRE)--Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, has announced a new agreement with HealthTrust Purchasing Group, L.P., (HealthTrust), for its Arrow Intra-Aortic Balloon Pump and Catheter products. The new agreement begins March 1, 2012 and extends through February 28, 2015. HealthTrust is a group purchasing...

4000th Patient Treated With Innovative Tryton Medical, Inc. Side Branch Stent

Wed, 15 Feb 2012 12:00:00 AM GMT

DURHAM, N.C.--(BUSINESS WIRE)--Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced that more than 4000 patients have been treated with the companys Tryton Side Branch Stent in Europe, Russia and the Middle East.

PREE Corporation's Heartfelt Infant Vitals and Video Monitoring System is Now in Pre-Sales

Wed, 15 Feb 2012 12:00:00 AM GMT

SAN ANTONIO--(BUSINESS WIRE)--The Heartfelt Infant Vitals and Video Monitoring System is now available for pre-sale for eager parents wanting greater peace of mind. Recent advances in technology have brought more options than ever for parents searching for the ideal baby monitor. PREE Corporation is anticipating that their heart and breathing rate sensor will be a game changer in the baby monitor...

Sorin Group S.p.A. Launches a New Complete Portfolio of Pacing, Defibrillation and Left Ventricular Leads

Tue, 31 Jan 2012 12:00:00 AM GMT

MILAN--(BUSINESS WIRE)--Sorin Group, (MIL:SRN) (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, announced CE Mark approval and commercial launch for a comprehensive new range of pacing, defibrillation and left ventricular leads. Designed for safety and long term reliability, TILDA pacing leads, VIGILA defibrillation leads and CELERITY left...

TomTec Imaging Systems GmbH Introduces 2D Cardiac Performance Analysis MR??* its Software Solution for Cardiac MR to Analyze Myocardial Function and Deformation

Mon, 30 Jan 2012 12:00:00 AM GMT

MUNICH--(BUSINESS WIRE)--At the upcoming SCMR meeting in Orlando Florida at February 2nd -5th TomTec introduces its 2D Cardiac Performance Analysis MR software product. The tool to quantify myocardial function and deformation based on regular cardiac MRI cine imaging.

Medtronic, Inc. Release: First Patient Enrolled in Medtronic-Supported Head-to-Head Clinical Trial Comparing Cryoballoon Ablation to RF Ablation for Paroxysmal Atrial Fibrillation

Tue, 24 Jan 2012 12:00:00 AM GMT

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) today announced the first patient was enrolled in the FIRE AND ICE clinical trial, which is a prospective, randomized, multinational head-to-head clinical trial comparing the long-term safety, effectiveness and ease of use of the Medtronic Arctic Front Cardiac CryoAblation System compared to the Biosense Webster CARTO System Guided THERMOCOOL...

Medtronic, Inc. Endurant?? II AAA Stent Graft System Launches Internationally with CE Mark

Tue, 17 Jan 2012 12:00:00 AM GMT

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic Inc. (NYSE: MDT) today announced the CE (Conformit Europenne) mark and international launch of the Endurant II AAA Stent Graft System, which meaningfully expands the options physicians outside the United States have to treat patients with abdominal aortic aneurysms through a minimally invasive technique called endovascular aortic repair (EVAR).

Medtronic, Inc. Endurant?? II AAA Stent Graft System Launches Internationally with CE Mark

Tue, 17 Jan 2012 12:00:00 AM GMT

Endosense Launches TactiCath?? 75 Force-Sensing Catheter, Announces New Results of EFFICAS I Clinical Study

Thu, 12 Jan 2012 12:00:00 AM GMT

GENEVA--(BUSINESS WIRE)--Endosense, a pioneer and leader in force-sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, has announced the European launch of the TactiCath 75 force-sensing ablation catheter as well as results of the EFFICAS clinical study of contact force-sensing in catheter ablation procedures.

"Heart-Less" Politician Goes From Short-Term Survival to 5th Term in Office With SynCardia Systems, Inc. Total Artificial Heart

Wed, 11 Jan 2012 12:00:00 AM GMT

Critical Diagnostics Release: Presage?? ST2 Assay Enters Routine Use for Heart Failure Patient Care

Tue, 03 Jan 2012 12:00:00 AM GMT

SAN DIEGO--(BUSINESS WIRE)--Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases, announced today that a major European medical center, Hospital Germans Trias i Pujol in Barcelona Spain, is now using the companys Presage ST2 Assay for routine care and management of their heart failure patients.

MindFrame Inc. Launches Registry to Improve Quality of Care for Patients Experiencing Ischemic Stroke

Wed, 28 Dec 2011 12:00:00 AM GMT

IRVINE, Calif.--(BUSINESS WIRE)--MindFrame Inc. today announces the establishment of an ischemic stroke Registry that will collect real-world clinical and procedural data through a secure web-based portal accessible only to registered clinician members. The goal is to support clinicians in advancing knowledge around the use of mechanical thrombectomy technologies for the treatment of patients suffering...

Cintas Announces 200th Life Save

Mon, 19 Dec 2011 12:00:00 AM GMT

CINCINNATI--(BUSINESS WIRE)--Cintas Corporation (NASDAQ: CTAS) today announced that its ReviveR Automatic External Defibrillator (AED) program has helped save 200 sudden cardiac arrest (SCA) victims. Cintas celebrates the landmark achievement with the recent save of Dave Carlstrom, who suffered from SCA after finishing a racquetball game at a gym in Seattle, Wash.

CMS, Inc. Coverage Reaffirmed for ZOLL Medical Corporation LifeVest Wearable Defibrillator

Thu, 15 Dec 2011 12:00:00 AM GMT

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of medical devices and related software solutions, announced today that the Centers for Medicare and Medicaid Services (CMS) Durable Medical Equipment Medical Administrative Contractors (DME MACs) reaffirmed the current coverage policy across all indications for the LifeVest Wearable Defibrillator.

Positron Corporation's Attrius Receives Health Canada Approval

Thu, 15 Dec 2011 12:00:00 AM GMT

FISHERS, Ind., Dec. 14, 2011 /PRNewswire/ -- Positron Corporation (OTCBB: POSC), a leading molecular imaging company specializing in the field of nuclear cardiology is pleased to announce today that on December 12, 2011, the Company's Positron Emission Tomography Scanner(s) Attrius...

CardioNet, Inc. Announces the Launch of its Next Generation MCOT??? Device

Wed, 14 Dec 2011 12:00:00 AM GMT

CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--CardioNet, Inc. (NASDAQ:BEAT), a leading wireless medical technology company with a current focus on the diagnosis and monitoring of cardiac arrhythmias, today announced the launch of its next generation Mobile Cardiac Outpatient Telemetry device.

St. Jude Medical Release: Study Determines FFR Can Improve Health while Reducing Economic Burden to Belgian Health Care System

Tue, 13 Dec 2011 12:00:00 AM GMT

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that an analysis of the benefits of using a Fractional Flow Reserve (FFR)-guided intervention in Belgium to determine the severity of blood flow blockages in patients coronary arteries can improve patient outcomes while saving millions of Euros.

Cardiovascular Systems, Inc.??? Stealth 360?? PAD System Honored as a New Technology of the Year by LifeScience Alley??

Tue, 13 Dec 2011 12:00:00 AM GMT

ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI; Nasdaq: CSII), Stealth 360 PAD System has been honored as a New Technology of the Year by LifeScience Alley. The annual award is given to the top 10 novel products that address a medical need, demonstrate the ability to improve healthcare and have significant market potential. Expert industry judges selected ground-breaking medical...

Boston Scientific Corporation Launches Charger??? PTA Balloon Catheter

Mon, 12 Dec 2011 12:00:00 AM GMT

NATICK, Mass., Dec. 12, 2011 -- /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces the U.S. launch of its Charger PTA Balloon Catheter, a 0.035" percutaneous transluminal angioplasty (PTA) balloon catheter designed for a wide range of peripheral angioplasty procedures. The Charger PTA Balloon Catheter is Boston Scientific's third new peripheral balloon catheter introduced in 20...

Abiomed Announces Expanded Heart Recovery Strategy with Multi Year Growth Initiatives

Mon, 12 Dec 2011 12:00:00 AM GMT

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today presented its expanded heart recovery strategy along with new initiatives that are expected to enhance strong, multi-year double digit sales and earnings growth. During its annual investor and analyst day in New York City, Abiomed will discuss the recently announced PROTECT...

Medtronic, Inc. Defibrillators Win FDA Panel Backing for Wider Use

Thu, 08 Dec 2011 12:00:00 AM GMT

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administrations (FDA) Circulatory Systems Devices Advisory Panel determined that the overall clinical benefits of Medtronic cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices outweigh the risks in treating certain mildly symptomatic heart failure patients...

Abiomed to Release New Data and Product Updates at Investor & Analyst Day on December 9

Thu, 08 Dec 2011 12:00:00 AM GMT

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, will release new data and product updates at its investor and analyst day on Friday, December 9, 2011, from 2:00 to 4:30 p.m. at the New York Palace in New York City.

Transradial Artery Access on the Rise and Affecting the Global Market for Vascular Closure Devices Through 2015, According to Life Science Intelligence

Wed, 07 Dec 2011 12:00:00 AM GMT

HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--According to a new Life Science Intelligence (LSI) report, Global Markets for Vascular Closure Devices: U.S., Europe, and the Rest of the World, the global market for vascular closure devices (VCDs) will exceed $800 million by 2015.

Sorin Group S.p.A. Announces CE Mark of INSPIRE(TM) New Family of Adult Oxygenators

Mon, 05 Dec 2011 12:00:00 AM GMT

MILAN--(BUSINESS WIRE)--Sorin Group, (MIL:SRN) (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today it has received CE (European Conformity) Mark for INSPIRETM 6, the first model of an entire new family of oxygenator systems for cardiopulmonary bypass procedures in adult patients.

IntriCon Corporation Receives FDA 510(k) Marketing Clearance for Sirona Cardiac Diagnostic Monitor

Thu, 17 Nov 2011 12:00:00 AM GMT

ARDEN HILLS, Minn.--(BUSINESS WIRE)--IntriCon Corporation (NASDAQ: IIN), a designer, developer, manufacturer and distributor of miniature and micro-miniature body-worn devices, today announced it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), for its Sirona Event and Holter Recorder. Sirona is the companys second-generation cardiac diagnostic monitoring ...

Toshiba Medical Systems Corporation???s Dual C-Arm Cath Lab Works Like Two Systems in a Single Room Making Exams Faster and Easier for Patients

Thu, 17 Nov 2011 12:00:00 AM GMT

TUSTIN, Calif.--(BUSINESS WIRE)--In cath lab procedures, the ability to freely move the X-ray system around the patient, clinicians and equipment is crucial to make exams faster, easier and safer. Ochsner Medical Center in New Orleans, La., installed the InfinixTM DP-i from Toshiba America Medical Systems, Inc. as a patient-friendly, single-system solution for both cardiac and peripheral applications...

CardioDx, Inc. Blood-Based Gene Expression Test Demonstrates Superior Performance to Myocardial Perfusion Imaging to Rule Out Obstructive Coronary Artery Disease

Wed, 16 Nov 2011 12:00:00 AM GMT

PALO ALTO, Calif.--(BUSINESS WIRE)--CardioDx, a pioneer in the field of cardiovascular genomic diagnostics, announced results of its COMPASS (Coronary Obstruction Detection by Molecular Personalized Gene Expression) trial, which were presented today at the American Heart Association Scientific Sessions 2011 conference in Orlando, Fla. This prospective, blinded multi-center study was designed to provide...

Clinical Trial Shows Berlin Heart, Inc.???s EXCOR?? Pediatric Ventricular Assist Device (VAD) Successfully Bridged 90% of Children with Severe Heart Failure Who Were Waiting for a Heart Transplant

Wed, 16 Nov 2011 12:00:00 AM GMT

THE WOODLANDS, Texas & BERLIN--(BUSINESS WIRE)--The Berlin Heart Group announced today that clinical trial data were presented this morning at the Scientific Sessions 2011 annual meeting of the American Heart Association (AHA). These data showed that, in a clinical trial of children with severe heart failure who were waiting for a heart transplant, 90% of patients in the primary cohort of the study...

CardiacAssist, Inc. Release: TandemHeart Included in New Treatment Guidelines

Wed, 16 Nov 2011 12:00:00 AM GMT

PITTSBURGH--(BUSINESS WIRE)--The TandemHeart circulatory support system has been added to the 2011 treatment guidelines coauthored by the American College of Cardiology Foundation (ACCF), the American Heart Association (AHA) and the Society for Cardiovascular Angiography & Interventions (SCAI). After extensive review of the body of clinical science and published literature, the societies released updated...

ZOLL Medical Corporation LifeVest Wearable Defibrillator Reduces Total Mortality after Cardiac Revascularization

Tue, 15 Nov 2011 12:00:00 AM GMT

AHA Scientific Sessions 2011

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL Medical Corporation (NASDAQ GS: ZOLL), a manufacturer of medical devices and related software solutions, announced that a study demonstrating a reduction in total mortality after cardiac revascularization in patients prescribed a LifeVest Wearable Defibrillator was presented at the American Heart Associations Scientific...

BioVentrix Completes Enrollment in Pilot Human Clinical Trial of the PliCath HF??? Heart Failure Treatment System