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Study of the Use of Control Catheters with the Sensei X Robotic System for the Treatment of Atrial Fibrillation

May 29, 2013 8:00 am | by The Associated Press | News | Comments

Hansen Medical, Inc., a global leader in intravascular robotics, today announced that it has received conditional approval from the U.S. Food and Drug Administration to change the study design of its ARTISAN-AF Trial, a pivotal clinical trial evaluating the use of Hansen Medical's Artisan® family of Control Catheters with its Sensei® X Robotic Catheter System for treatment of Atrial Fibrillation, the most common cardiac arrhythmia.

Teleflex Announces European Market Clearance for its Arrow® GPSCath® Balloon Dilatation Catheter

May 29, 2013 7:30 am | by Business Wire | News | Comments

Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, has announced that its subsidiary Hotspur Technologies, Inc., which Teleflex acquired in June 2012, completed CE marking requirements to market the company’s Arrow ® GPSCath ® Balloon Dilatation Catheters to the European Union.

FDA Approves Blood Test to Diagnose Diabetes

May 28, 2013 10:56 am | by The Associated Press | News | Comments

The Food and Drug Administration said Thursday it approved a new blood test from Roche to help doctors diagnose diabetes. The Cobas Integra 800 is a blood test that measures a patient's average blood sugar level over the previous three months. In particular, the test measures an oxygen-carrying blood component known as hemoglobin.

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Heli-FX™ Guide Designed to Treat Wide Neck Abdominal Aortic Aneurysms Receives FDA Clearance

May 28, 2013 8:15 am | by Business Wire | News | Comments

Aptus Endosystems, Inc. announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 28mm Tip Reach Heli-FX™ Guide. A line extension of the original Heli-FX System, the new product enhances treatment of wide neck abdominal aortic aneurysms (AAA).

OrbusNeich Launches World's First Dual Therapy Stent That Addresses Challenges of Delayed Coronary Artery Healing Associated with Monotherapy Drug Eluting Stents

May 27, 2013 3:00 am | by The Associated Press | News | Comments

OrbusNeich today launched the world's first dual therapy stent - the COMBO Dual Therapy Stent - to address the challenges of delayed healing of the coronary artery associated with monotherapy drug eluting stents (DES), the current standard of care for the treatment of coronary artery disease...

Biosensors Completes Spectrum Dynamics Assets Acquisition

May 26, 2013 8:02 am | by The Associated Press | News | Comments

Biosensors International Group, Ltd., a developer, manufacturer and marketer of innovative medical devices, today announced the completion of its acquisition of substantially all assets of Spectrum Dynamics, a leader in advanced functional assessment technologies, including those used to evaluate patients for cardiac interventions.

Feasibility Trial Reports Deployment of New Device for TAVI in Aortic Insufficiency

May 24, 2013 11:09 am | by European Society of Cardiology | News | Comments

A new investigational device—the Helio System (TF-FA) —being developed for use with the Sapien XT Transcatheter Heart Valve was successfully deployed in all four patients in a small, first-in-human feasibility study of its use in high-risk aortic insufficiency reported at EuroPCR 2013.

Registry Confirms TAVI Efficacy and Safety in Asian Patients

May 24, 2013 11:05 am | by European Society of Cardiology | News | Comments

Transcatheter aortic valve implantation is effective and safe in Asian patients, according to early experience based on first results from a multicentre Asian registry reported at EuroPCR 2013. "TAVI has become a treatment option for selected patients with symptomatic severe aortic stenosis. But current data are virtually all from North American or European centres," Paul Chiam told the conference.

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CardioKinetix Announces Successful Parachute Live Case Transmission at 2013 EuroPCR Conference

May 24, 2013 8:27 am | by Business Wire | News | Comments

PARIS & MENLO PARK, Calif.--(BUSINESS WIRE)--May 24, 2013--CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced the transmission of a live satellite feed of a clinical case using the first-of-its-kind catheter-based Parachute ®...

Class I Medical Device Recall: Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent

May 24, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Cook Medical received a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Potential adverse events that may occur in cases where the inner deliver catheter breakage...

Hansen Medical to Exhibit Magellan Robotic System at 2013 Vascular Annual Meeting of the Society for Vascular Surgery

May 23, 2013 4:03 pm | by The Associated Press | News | Comments

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that it will exhibit its Magellan™ Robotic System at the 2013 Vascular Annual Meeting® of the Society for Vascular Surgery from May 30 - June 1 at the Moscone West Convention Center in San...

Cardiovascular Systems Presents New Late-Breaking Coronary Results at EuroPCR Conference

May 23, 2013 10:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--May 23, 2013--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), presented 30-day results from its ORBIT II study of coronary artery disease in a late-breaking presentation at the 2013 European Association of Percutaneous Cardiovascular Interventions (EuroPCR)...

Medtronic Completes Enrollment in Landmark U.S. Study of Symplicity Renal Denervation System for Treatment-Resistant Hypertension

May 23, 2013 6:06 am | by The Associated Press | News | Comments

Medtronic, Inc., today announced it has finished randomizing Symplicity HTN-3, the company's pivotal U.S. clinical trial of the Symplicity renal denervation system for treatment-resistant hypertension. Renal denervation is a minimally invasive, catheter-based procedure to reduce activity of the renal (kidney) nerves, which are part of the sympathetic nervous system and help regulate blood pressure.

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InspireMD's MGuard Embolic Protection Stent (EPS) Shows Lower Mortality Rate in STEMI Patients at Six Months Compared to Control Group

May 23, 2013 6:00 am | by PR Newswire | News | Comments

InspireMD, Inc., the leader in embolic protection stents, today announced new 6-month results from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial demonstrating that the MGuard Embolic Protection Stent (EPS) outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients.   

Volcano Announces Preliminary Results from the ADVISE II Study and Inclusion in the SYNTAX2 Trial During Hot Line Late Breaking Clinical Trial Sessions at EuroPCR 2013

May 23, 2013 4:30 am | by PR Newswire | News | Comments

SAN DIEGO and PARIS, May 23, 2013 /PRNewswire/ -- Volcano Corporation (NASDAQ: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced preliminary...

One Year Data from St. Jude Medical Study Demonstrates Safe, Rapid and Sustained Blood Pressure Reduction with EnligHTN Renal Denervation Technology

May 23, 2013 4:15 am | by The Associated Press | News | Comments

ST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--May 23, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the company’s EnligHTN ™ Multi-Electrode Renal Denervation System provides a safe, rapid and sustained reduction in blood pressure measurements after...

New Data Demonstrate Significant And Sustained Blood Pressure Reduction With Boston Scientific Vessix™ Renal Denervation System

May 22, 2013 12:20 pm | by PR Newswire | News | Comments

PARIS, May 22, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today reported interim data from the REDUCE-HTN clinical program, which demonstrated a significant and sustained reduction in the blood pressure of patients treated with the Vessix™ Renal Denervation...

CardioKinetix Announces Positive Clinical Data Showing Consistent Compelling Positive Results for Patients Treated with Minimally Invasive Structural Heart Device for Heart Failure

May 22, 2013 11:00 am | by The Associated Press | News | Comments

PARIS & MENLO PARK, Calif.--(BUSINESS WIRE)--May 22, 2013--CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced results of a meta-analysis study of the first-of-its-kind catheter-based Parachute ® Ventricular Partitioning Device....

Evaluating a New Way to Open Clogged Arteries

May 22, 2013 10:42 am | by Anne Trafton, MIT News Office | News | Comments

Over the past few decades, scientists have developed many devices that can reopen clogged arteries, including angioplasty balloons and metallic stents. While generally effective, each of these treatments has drawbacks, including the risk of side effects. A new study from MIT analyzes the potential usefulness of a new treatment that combines the benefits of angioplasty balloons and drug-releasing stents, but may pose fewer risks.

BioVentrix to Exhibit Revivent™ System, which Surpasses Survival Benefit Threshold for Heart Failure Treatment, at European Heart Failure Congress

May 22, 2013 8:30 am | by The Associated Press | News | Comments

LISBON, Portugal--(BUSINESS WIRE)--May 22, 2013--BioVentrix, pioneer of the Less Invasive Ventricular Enhancement™ (LIVE™) procedure for the treatment of heart failure (HF), announced today that it will showcase its Revivent™ Myocardial Anchoring System at the European Heart Failure Congress (HFC)...

St. Jude Medical EnligHTNment Study Highlighted at EuroPCR During Trials That May Change Clinical Practice Session

May 21, 2013 9:52 am | by The Associated Press | News | Comments

ST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--May 21, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the start of its landmark EnligHTNment clinical study. This is the largest randomized, prospective trial to determine whether renal denervation and...

Economic Model of the Life-time Cost Impact of Heart Valve Prosthetic Choice to be Presented at ISPOR Meeting

May 21, 2013 9:00 am | by The Associated Press | News | Comments

AUSTIN, Texas--(BUSINESS WIRE)--May 21, 2013--On-X® Life Technologies, Inc. (On-X LTI) announced today that a cost analysis entitled, “Initial Heart Valve Replacement Prosthetic Choice Has Long-Term Complications and Cost Impact: A Comparative Analysis,” will be presented in poster form at the...

MAQUET Cardiovascular Acquires LAAx Inc. and Its TigerPaw System II Occlusion Device to Expand Cardiac Surgery Offering

May 21, 2013 8:00 am | by The Associated Press | News | Comments

MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced that it has acquired LAAx Inc., a privately held company that has developed a unique mechanical occlusion device called the TigerPaw@ System II ("TigerPaw II"). When implanted, TigerPaw II safely and...

VerrataT Pressure Guide Wire and iFR@ (Instant Wave-Free RatioT) Software Modality will be on display at EuroPCR 2013[1]

May 21, 2013 4:40 am | by The Associated Press | News | Comments

Volcano Corporation (NASDAQ: VOLC) a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced that it will demonstrate the VerrataT Pressure Guide Wire and the iFR@ (Instant...

Medtronic Finds TAVI with CoreValve System Cost Effective for Treating Patients with Severe Aortic Stenosis

May 21, 2013 4:06 am | by The Associated Press | News | Comments

Focused on offering devices that provide both clinical and economic value, Medtronic, Inc. unveiled the results of a cost-effectiveness model comparing transcatheter aortic valve implantation with the CoreValve System to medical management. Presented at EuroPCR 2013, the United Kingdom-based analysis compared the "real world" Medtronic CoreValve ADVANCE study to the medical management cohort of the PARTNER B study.

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