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Implantable Pulse Generators ‘Stimulate’ Medical Device Industry

January 4, 2012 11:46 am | by Chris Vaillancourt | Articles | Comments

In recent years, there has been great excitement about the use of neuromodulation to treat a wide array of medical conditions and diseases. The technology uses electrical signals to stimulate or block different nerve impulses in the body and is adapted from technology used in cardiac rhythm management. Advanced ceramic materials are playing an important role in the technology and are poised to play an even greater one as these medical devices flood onto the market to treat an increasing number of ailments.

SeptRx reports first 20 patients have been enrolled in its “InterSEPT" CE Mark trial of the SeptRx Intrapocket PFO Occluder

January 4, 2012 5:44 am | News | Comments

FREMONT, Calif.--(BUSINESS WIRE)--SeptRx, an emerging medical device company that has developed the SeptRx® Intrapocket PFO Occluder (IPO) - a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO) - reported today that it has completed...

BioLineRx Announces Initiation of CE Mark Registration Trial for BCM (BL-1040), a Novel Medical Device for Prevention of Cardiac Remodeling Following Acute Myocardial Infarction

January 4, 2012 5:35 am | News | Comments

JERUSALEM--(BUSINESS WIRE)--BioLineRx, a biopharmaceutical development company, announced today the commencement of the PRESERVATION I clinical trial, a CE Mark registration trial of BCM (BL-1040), a novel medical device intended for the prevention of cardiac remodeling...

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Presage® ST2 Assay Enters Routine Use for Heart Failure Patient Care

January 3, 2012 4:34 am | News | Comments

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 company's Presage® ST2 Assay for routine care...

Bard Acquires Lutonix, Inc.

December 22, 2011 5:45 am | News | Comments

MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. today announced that it has acquired Lutonix, Inc. for a purchase price of approximately $225 million paid at closing, with an additional $100 million to be paid upon PMA approval of Lutonix's drug-coated percutaneous transluminal angioplasty (PTA) balloon.

Tryton Announces DRG Reimbursement Code for Side Branch Stent in Germany

December 21, 2011 6:39 am | News | Comments

DURHAM, N.C.--(BUSINESS WIRE)--Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, announced that the German Institute for Medical Documentation and Information (DIMDI, Cologne) has revised the procedure code for the treatment of coronary bifurcations lesions...

CADD-Solis VIP Ambulatory Infusion System Launches in Additional European Markets

December 21, 2011 6:34 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Smiths Medical, a leading global medical device manufacturer, announced today it launched the CADD®-Solis VIP ambulatory infusion system with CADD™-Solis medication safety software in France, Germany, Switzerland and the Netherlands.

AtriCure's Synergy Ablation System Receives FDA Approval for the Treatment of Atrial Fibrillation

December 20, 2011 4:51 am | News | Comments

WEST CHESTER, Ohio--(BUSINESS WIRE)--AtriCure, Inc., a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, today announced that the U.S. Food and Drug Administration (FDA) has approved...

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Berlin Heart's EXCOR Pediatric Ventricular Assist Device (VAD) Receives FDA Approval

December 20, 2011 4:46 am | News | Comments

THE WOODLANDS, Texas & BERLIN--(BUSINESS WIRE)--The Berlin Heart Group announced today that the FDA has granted “Humanitarian Device Exemption” (HDE) approval of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD). The Berlin Heart EXCOR® Pediatric VAD...

AngioScore Announces Successful Initiation of Enrollment in Drug-Coated AngioSculpt Scoring Balloon Catheter First-in-Human Study

December 15, 2011 5:49 am | News | Comments

FREMONT, Calif.--(BUSINESS WIRE)--AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, today announced the successful initiation of enrollment in the Drug-Coated AngioSculpt Scoring Balloon Catheter First-in-Human (FIH) Study.

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

December 15, 2011 5:44 am | News | Comments

CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--CardioNet, Inc., 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 Announces First Implant in European Clinical Trial Studying Portico Transcatheter Aortic Heart Valve

December 14, 2011 4:14 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first implant of its Porticoâ„¢ transcatheter aortic valve implant (TAVI) in a European clinical trial to support CE Mark approval. The trial will study the safety and effectiveness...

Cardiovascular Systems' Stealth 360° PAD System Honored as a New Technology of the Year by LifeScience Alley

December 14, 2011 4:12 am | News | Comments

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...

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Study Determines FFR Can Improve Health while Reducing Economic Burden to Belgian Health Care System

December 14, 2011 4:03 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc., 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...

Aptus Endosystems Completes First HeliFX Procedures in U.S.

December 13, 2011 5:27 am | News | Comments

SUNNYVALE, Calif.--(BUSINESS WIRE)--Aptus Endosystems Inc., a medical device company developing advanced technology for endovascular aneurysm repair (EVAR), announced the successful treatment of the first series of patients in the United States with the HeliFXTM Aortic Securement System...

Phase One Medical Announces Second Patent Issuance For Their Distal Locking Hemodialysis Catheter System

December 13, 2011 5:23 am | News | Comments

HINGHAM, Mass.--(BUSINESS WIRE)--Phase One Medical, L.L.C. a privately held medical device research and development company announced today that the U.S. Patent and Trademark Office has issued a second patent covering their Distal Locking Hemodialysis Catheter Technology.

Nonin Medical GO2 Finger Pulse Oximeter to be Featured on The Balancing Act TV Show on Lifetime Television

December 12, 2011 3:40 pm | by Bio-Medicine.Org | News | Comments

MINNEAPOLIS, Dec. 12, 2011 /- Nonin Medical, Inc., the inventor of finger pulse oximetry and a leader in noninvasive medical monitoring, today announced that the GO2™ Personal Finger Pulse Oximeter will be featured on "The Balancing Act" TV Show on Lifetime Television,...

Bluegrass Vascular Technologies Begins First Clinical Study of the Surfacer Inside-Out Access Catheter System

December 12, 2011 4:23 am | News | Comments

LEXINGTON, Ky.--(BUSINESS WIRE)--Bluegrass Vascular Technologies, a medical technology company focused on life-saving devices and methods for vascular access procedures, has announced patient enrollment in the first clinical study of its Surfacerâ„¢ Inside-Out Access Catheter System...

FDA Advisory Panel Recommends Expanded Indication for Medtronic Cardiac Resynchronization Therapy with Defibrillator (CRT-D) Devices

December 9, 2011 5:35 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration's (FDA) Circulatory Systems Devices Advisory Panel determined that the overall clinical benefits of Medtronic cardiac resynchronization therapy...

COMPAS Trial Results Demonstrate the Safety and Efficacy of Daily Remote Monitoring with BIOTRONIK Home Monitoring in Pacemaker Patients

December 8, 2011 4:42 am | News | Comments

BERLIN--(BUSINESS WIRE)--BIOTRONIK today announced the publication of the COMPAS clinical trial results in the European Heart Journal1. COMPAS is the first large-scale, prospective, multi-center, randomized clinical trial to demonstrate the safety and efficacy of remote monitoring...

Cook Medical is Awarded New Contract with Novation for Cook Central Venous Catheters

December 5, 2011 4:24 am | News | Comments

Bloomington, Ind., December 5, 2011 – Beginning January 1, 2012, Cook Medical's central venous catheters (CVCs) will be available to the members served by Novation, the supply contracting company for more than 30,000 members of VHA Inc., UHC, and Provista. This expands nationwide access...

Covidien's Embolic Protection Device Receives FDA Clearance

December 2, 2011 4:35 am | News | Comments

MANSFIELD, Mass.--(BUSINESS WIRE)--Covidien, a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has cleared SpiderFX® for the treatment of severely calcified lesions used in conjunction with plaque excision...

St. Jude Medical Announces FDA Approval of Industry's First Quadripolar Pacing System

December 1, 2011 6:07 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc., a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) approval of its Unify Quadra® cardiac resynchronization therapy defibrillator (CRT-D) and Quartet® Left Ventricular Quadripolar Pacing Lead.

Emboline receives U.S. allowance for key piece of its seminal patent portfolio of aortic embolic protection technologies for percutaneous heart valve procedures such as TAVR

December 1, 2011 5:54 am | News | Comments

FREMONT, Calif.--(BUSINESS WIRE)--Emboline, Inc., an emerging medical device company, has received Notice of Allowance from the United States Patent and Trademark Office (USPTO) related to its aortic embolic protection devices for percutaneous heart valve repair and replacement.

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

November 17, 2011 5:39 am | News | Comments

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...

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