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Cameron Health Submits PMA Application to FDA for the S-ICD System

January 10, 2012 6:33 am | News | Comments

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Cameron Health, Inc. (“Cameron Health”) announced today that it has submitted the Premarket Approval (PMA) application to the Food and Drug Administration (FDA) for the S-ICD System, the world's only completely subcutaneous implantable defibrillator.

US Interventional Cardiology Device Market Will Shrink by Three Percent Per Year Through 2016

January 10, 2012 6:19 am | News | Comments

TORONTO--(BUSINESS WIRE)--According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, interventional cardiology devices in the United States will see a shrinking overall market due to a maturity in procedures and heavy downward pressures...

MedPlast's Pessary Balloon Manufacture Showcases Multi-Function Technical Mastery(2)

January 10, 2012 6:09 am | News | Comments

ELKHORN, Wis. -- MedPlast, Inc.'s ability to craft the pessary balloons that enhance quality of life for many women underscores the company's commitment to premium quality output and complete mastery of many separate - and complex - processes. Today's pessaries are precision-manufactured...

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SANUWAVE Issued U.S. Patent for the Application of Acoustic Shock Waves Utilizing Its PACE Devices

January 9, 2012 5:48 am | News | Comments

ALPHARETTA, Ga.--(BUSINESS WIRE)--SANUWAVE Health, Inc., an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announced that the U.S. Patent and Trademark Office...

MindFrame Inc. Awarded New Patent for Breakthrough Capture LP Thrombectomy Technology

January 6, 2012 5:21 am | News | Comments

IRVINE, Calif.--(BUSINESS WIRE)--MindFrame Inc. today announces the issuance of U.S. Patent No. 8,088,140, bringing the total number of patents awarded for its breakthrough thrombectomy technology to three. The previous two patents, U.S. Patent Nos. 8,066,757 and 8,070,791...

New generation drug-eluting stents associated with lower rates of mortality and restenosis than bare metal stents

January 6, 2012 4:56 am | News | Comments

A registry -which includes every patient in Sweden having percutaneous coronary intervention (PCI) for the treatment of acute and stable coronary artery disease- has found that PCI implantations using a new generation of drug-eluting stents is associated with lower rates of relapse...

An Outside Perspective: Joining Forces to Bring New Technology to Market

January 5, 2012 10:53 am | by John Havard | Articles | Comments

Medical device manufacturers that attempt to handle too many tasks in the product development process without the sufficient level of competency are simply setting themselves up for failure. It is vital for them to maintain a strong expertise in those core competencies and look outside for strategic partners who can aid them. This article examines that for the product design process.

CircuLite Awarded Grant from Cardiovascular Medical Research and Education Fund to Develop Right-Heart Circulatory Support System for Patients with Pulmonary Arterial Hypertension (PAH)

January 5, 2012 5:27 am | News | Comments

SADDLE BROOK, N.J.--(BUSINESS WIRE)--CircuLite®, Inc. today announced that it has received a grant from the Cardiovascular Medical Research and Education Fund, Inc. (CMREF) to fund the development of a right-heart circulatory support system based upon CircuLite's Synergy® Micro-pump...

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Roche and Itamar-Medical Move Forward in Developing EndoPAT for Pre-Clinical Longitudinal Studies

January 5, 2012 5:15 am | News | Comments

CAESAREA, Israel--(BUSINESS WIRE)--Itamar-Medical, the world's leader of non-invasive devices for diagnosis of cardiovascular health, announced achievement of the next milestone of the international pharmaceutical company, Roche, to further develop the EndoPAT technology for pre-clinical trials.

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...

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...

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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...

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...

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.

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