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Biotronik Lands Euro Approval for MRI-Friendly Heart Implants

February 22, 2013 9:29 am | by Mass Device | News | Comments

German medical device maker Biotronik won European regulatory approval for its Ilesto 7 line of MRI-friendly heart implants. The Ilesto 7 line includes cardiac resynchronization therapy defibrillator and one of the world's smallest implantable cardioverter-defibrillators, according to Biotronik.

NMMC Physicians Implant State's First Vagal Nerve Stimulator for Heart Failure

February 21, 2013 3:39 pm | by The Associated Press | News | Comments

Doctors at North Mississippi Medical Center recently implanted the state's first vagal nerve stimulator as part of a clinical research study to treat heart failure through nerve stimulation in the neck. According to cardiac electrophysiologist Karl Crossen, M.D., and neurosurgeon Louis...

OrbusNeich Rides Patent Win Over Boston Scientific to Germany, Netherlands

February 21, 2013 12:24 pm | by Mass Device | News | Comments

OrbusNeich is taking a recent patent infringement win against Boston Scientific even further, filing lawsuits in both Germany and the Netherlands to allege patent infringement over stent technology. OrbusNeich claims Boston Scientific's Promus Element, Promus Element Plus, Taxus, and other stents are infringing on a pair of patents.

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Covidien Closes Enrollment in Iliac Stent Studies

February 21, 2013 11:38 am | by Mass Device | News | Comments

Covidien said it closed enrollment in a pair of its Visibility and Durability iliac stent clinical studies. The prospective, multinational studies are designed to compare balloon stents with self-expanding stents in the iliac arteries for treating peripheral artery disease.

SynCardia Total Artificial Heart Patient with End-Stage Renal Failure Recovers Kidney Function after Two Months of Support

February 21, 2013 5:51 am | by Bio-Medicine.Org | News | Comments

TUCSON, Ariz. , Feb. 21, 2013 /- At only 20 years old, Tiernee Gonzalez has been battling two major diseases for most of her young life: heart failure and kidney failure. When she became the first patient at Cincinnati Children's Hospital Medical Center to receive the SynCardia temporary Total Artificial Heart on Nov. 9, her doctors hoped it would bring her one step closer...

AngioLight Lands Strategic Partnership with Medical Technologies Innovation Asia, Names Gary Saxton President

February 20, 2013 7:00 am | by The Associated Press | News | Comments

MEDFORD, Mass.--(BUSINESS WIRE)--Feb 20, 2013--Interventional cardiology medical device company AngioLight has engaged in a strategic partnership with Medical Technologies Innovation Asia (MTIA), Hong Kong, under which MTIA will complete safety, animal and clinical studies of AngioLight’s...

Covidien Completes Patient Enrollment in Iliac Stent Clinical Study Series

February 20, 2013 7:00 am | by The Associated Press | News | Comments

MANSFIELD, Mass.--(BUSINESS WIRE)--Feb 20, 2013--Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the completion of patient enrollment in its iliac stent clinical study series. The series is composed of two prospective, multinational, multicenter studies -...

Cardiovascular Systems Sponsoring Orbital Atherectomy Sessions at iCON 2013

February 19, 2013 3:00 pm | by The Associated Press | News | Comments

ST. PAUL, Minn. & SCOTTSDALE, Ariz.--(BUSINESS WIRE)--Feb 19, 2013--Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announced today it is sponsoring a challenging case presentation featuring its peripheral orbital atherectomy system, and co-hosting an office-based lab presentation and...

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Medtronic Announces FDA Approval and Launch of Its Advisa MRI Pacemaker System

February 19, 2013 2:22 pm | by Medtronic | News | Comments

Showcasing its leadership position in pacing technologies, Medtronic, Inc. announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of its Advisa DR MRI SureScan pacing system. The Advisa MRI system is Medtronic’s second-generation MR-Conditional pacemaker and is the first system to combine the most advanced pacing technology with proven MRI access.

New Handheld ECG Device Helps Physicians Identify Risks for Sudden Cardiac Arrest in Young Athletes

February 19, 2013 11:51 am | by The Associated Press | News | Comments

SEATTLE--(BUSINESS WIRE)--Feb 19, 2013--Cardea Associates, a company dedicated to improving heart health through product innovation and research, announces the launch of its new electrocardiographic (ECG) device, CardeaScreen. Specifically in-tune with normal conditions for the athletic heart,...

Cardiovascular Systems to Present Three-Year Orbit I Coronary Data at 2013 Cardiovascular Research Technologies Conference

February 19, 2013 9:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn., & WASHINGTON--(BUSINESS WIRE)--Feb 19, 2013--Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII), will present three-year data from its ORBIT I study of coronary artery disease (CAD) in a poster session at the 2013 Cardiovascular Research Technologies (CRT) conference in...

Terumo Medical Corporation Files Patent Infringement Lawsuit Against Vascular Solutions And Lepu Medical Technology Company

February 19, 2013 7:31 am | by The Associated Press | News | Comments

Terumo Medical Corporation (Terumo), today announced that it has filed a patent infringement lawsuit against Vascular Solutions Inc. and Lepu Medical Technology (Beijing) Co., Ltd in the U.S. District Court of New Jersey. The complaint alleges that R BandT Radial Hemostasis Device ...

Sorin Group Announces the Acquisition of Alcard

February 19, 2013 3:30 am | by The Associated Press | News | Comments

MILAN--(BUSINESS WIRE)--Feb 19, 2013--Sorin Group (MIL:SRN) (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the acquisition of Alcard Industria Mecanica Ltda (“Alcard”), a Brazilian leading manufacturer of medical...

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AtriCure to Announce Fourth Quarter and Full Year 2012 Financial Results

February 18, 2013 5:23 pm | by The Associated Press | News | Comments

WEST CHESTER, Ohio--(BUSINESS WIRE)--Feb 18, 2013--AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, will release its financial results for the fourth quarter and full year 2012 on...

Turnabout is Fair Play for Boston Scientific in Guidant Lawsuit

February 18, 2013 11:44 am | by Mass Device | News | Comments

For Boston Scientific and its ongoing legal woes over the blockbuster acquisition of Guidant Corp. , you win some and you lose some. The Natick, Mass.-based medical device company won a bid in December to compel the release of Medicare documents in a whistleblower lawsuit accusing Guidant and its corporate parent of concealing problems with Guidant's implantable cardiac defibrillators.

Abbott's MitraClip Gets a Date with the FDA

February 15, 2013 2:28 pm | by Mass Device | News | Comments

The FDA's Circulatory System Devices Panel will review data and make recommendations on Abbott's MitraClip aortic valve repair system. Abbott (NYSE:ABT) landed an FDA panel date to review its MitraClip aortic valve repair system, according to an FDA notice.

FDA Approvies Lombard Med. Tech.'s Aorfix Stent Graft for Treating Highest Neck Angulation

February 15, 2013 1:24 pm | by Mass Device | News | Comments

British medical device maker Lombard Medical Technologies won premarket approval from the FDA to market its Aorfix flexible stent graft in the U.S. The FDA win gives Lombard permission to market the Aorfix device in treatment of challenging neck angulations from the range of 0 to 90 degrees.

Hypertension: ReCor Launches Post-Market Study of Next-Gen Paradise System

February 15, 2013 12:26 pm | by Mass Device | News | Comments

California medical device startup ReCor Medical launched a post-market study of its next-generation Paradise renal denervation system in treatment of patients with resistant high blood pressure. The 50-patient study has already enrolled patients at a participating facility in the Netherlands with the Paradise device.

St. Jude Looks Beyond Blood Pressure for Benefits of Renal Denervation

February 15, 2013 12:06 pm | by Mass Device | News | Comments

St. Jude Medical is aiming to take its renal denervation therapy a step further, looking for signs that the minimally invasive treatment improves health beyond lowering high blood pressure in patients with uncontrolled hypertension. The company's new Enlightnment trial is looking for long-term effects of renal denervation therapy...

St. Jude Medical Initiates Landmark Study of Renal Denervation for Reduction of Heart Attack, Stroke and Death

February 15, 2013 8:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Feb 15, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced plans for a new landmark study that will evaluate whether renal denervation and medication can provide health benefits to patients beyond lowering high blood...

BIOTRONIK Ilesto 7 ICD/CRT-D Series With ProMRI(R) Technology Gains CE Approval

February 15, 2013 4:00 am | by The Associated Press | News | Comments

BIOTRONIK, the leading manufacturer of cardiovascular medical technology that is celebrating its 50th anniversary in 2013, announced today that the Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series has received CE...

Meeting Announcement: March 20, 2013 Circulatory System Devices Panel of the Medical Devices Advisory Committee

February 15, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On March 20, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists of three major components: the delivery catheter, the steerable sleeve, and the MitraClip device.

Bard to Present at Citi 2013 Global Healthcare Conference

February 14, 2013 4:21 pm | by The Associated Press | News | Comments

MURRAY HILL, N.J.--(BUSINESS WIRE)--Feb 14, 2013--C. R. Bard, Inc. (NYSE: BCR) today announced that it will present at the Citi 2013 Global Healthcare Conference in New York City on February 27, 2013. Timothy M. Ring, chairman and chief executive officer, will discuss the Company in a presentation...

Tigre Becomes First Heart Safe City in Argentina by Implementing ZOLL AED Plus

February 13, 2013 2:59 pm | by The Associated Press | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--Feb 13, 2013--ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that the city of Tigre in the Province of Buenos Aires, has installed ZOLL AED Plus ® units in public areas throughout this popular tourist...

Medtronic Announces FDA Approval and Launch of Its Advisa MRI Pacemaker System

February 13, 2013 9:06 am | by The Associated Press | News | Comments

Second-generation MR-Conditional Pacemaker Combines Advanced Pacing Technology with MRI Access MINNEAPOLIS - February 13, 2013 - Showcasing its leadership position in pacing technologies, Medtronic, Inc. (NYSE: MDT), today announced the...

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