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Open Heart Articles & Analysis

17 news found

1st Successful Heart Tumor Removal Without Open Heart Surgery

1st Successful Heart Tumor Removal Without Open Heart Surgery

Cloud Hospital with the first team to remove a heart tumor without invasive open heart surgery using the novel AlphaVac catheter. ...

ByEchoPixel, Inc.


Deborah Heart and Lung Center Introduces the Ivenix Infusion System to the Hospital

Deborah Heart and Lung Center Introduces the Ivenix Infusion System to the Hospital

Deborah Heart and Lung Center announces its successful hospital-wide go live with Ivenix, a modern smart infusion pump system. ...

ByIvenix, Inc.


JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited

JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited

“Currently, there are no transfemoral TAVR devices approved for aortic regurgitation in China; however, some patients with severe aortic regurgitation have to be treated by off-label use of TAVR devices as they are not eligible for open-heart surgery. The Trilogy TM System provides a new treatment option to doctors and brings hope to aortic regurgitation ...

ByJenaValve Technology, Inc.


Impulse Dynamics Receives FDA Approval to Modify Labeling for Optimizer Smart Medical Devices

Impulse Dynamics Receives FDA Approval to Modify Labeling for Optimizer Smart Medical Devices

“We applaud the FDA’s decision based on clinical evidence provided to remove the previous barrier to CCM therapy concerned with heart rhythm, opening it up to additional patients in need,” said Jason Spees, President and Chief Commercial Officer of Impulse Dynamics. ...

ByImpulse Dynamics


First Patient Enrolled in U.S. STAR-T Pivotal Trial Evaluating the DrugSorb-ATR Antithrombotic Removal System to Remove Ticagrelor During Cardiothoracic Surgery

First Patient Enrolled in U.S. STAR-T Pivotal Trial Evaluating the DrugSorb-ATR Antithrombotic Removal System to Remove Ticagrelor During Cardiothoracic Surgery

Each year, ticagrelor is prescribed to millions of cardiovascular patients worldwide to reduce the risk of recurrent heart attack, stroke, or cardiovascular death. Ticagrelor is frequently preferred as first-line therapy in patients presenting to hospitals with an acute coronary syndrome in preparation of percutaneous coronary intervention (PCI) and stent placement. However, up ...

ByCytoSorbents Corporation


JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System

JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System

The Trilogy Heart Valve System is the first and only transfemoral TAVR system in the world indicated for the treatment of aortic regurgitation. ...

ByJenaValve Technology, Inc.


CytoSorbents Receives Full FDA Investigational Device Exemption (IDE) Approval to Begin U.S. STAR-D Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR Antithrombotic Removal System During Urgent Cardiothoracic Surgery

CytoSorbents Receives Full FDA Investigational Device Exemption (IDE) Approval to Begin U.S. STAR-D Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR Antithrombotic Removal System During Urgent Cardiothoracic Surgery

FDA marketing approval for the intraoperative removal of the key blockbuster antithrombotic drugs Brilinta®, Eliquis® and Xarelto® during open heart surgery to reduce the risk of perioperative bleeding. If successful, we intend to establish DrugSorb-ATR as the go-to, easy-to-use, potential standard of care single treatment for this application in the ...

ByCytoSorbents Corporation


CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference

CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference

A summary of the abstracts are as follows: The REMOVE (“Revealing Mechanisms and Investigating Efficiency Of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients with Infective Endocarditis“) investigator initiated randomized, controlled trial enrolled 288 patients with documented infective endocarditis with a EuroSCORE II (European System for Cardiac ...

ByCytoSorbents Corporation


JenaValve Receives IDE Approval to Initiate The ALIGN-AR Pivotal PMA Trial

JenaValve Receives IDE Approval to Initiate The ALIGN-AR Pivotal PMA Trial

The current treatment for high surgical risk patients who are not candidates for open-heart surgery consists predominantly of medical management and off-label TAVR. “We are pleased the FDA granted this IDE approval allowing us to continue our pursuit of an aortic regurgitation indication for the Trilogy Heart Valve System,” said John ...

ByJenaValve Technology, Inc.


JenaValve Technology Receives CE Mark for its Trilogy TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis

JenaValve Technology Receives CE Mark for its Trilogy TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis

The Trilogy Heart Valve System is the first transfemoral device of its kind to receive CE mark approval for the treatment of both severe symptomatic aortic regurgitation and aortic stenosis. ...

ByJenaValve Technology, Inc.


JenaValve Technology Welcomes Jane Metcalf as Vice President, Regulatory Affairs and Quality

JenaValve Technology Welcomes Jane Metcalf as Vice President, Regulatory Affairs and Quality

“I am excited Jane is joining us at this pivotal time as we continue to enroll patients into our ALIGN-ARclinical trial and move forward in our efforts to commercialize our TrilogyTM heart valve for the treatment of aortic regurgitation. Herleadership will be critical to the success of JenaValve and our ability to expand patient and physician ...

ByJenaValve Technology, Inc.


Spotlight from Canada Economic Development on Puzzle Medical`s journey

Spotlight from Canada Economic Development on Puzzle Medical`s journey

Together, they observed that current treatments for heart failure are not optimal, are very costly and are invasive for the patient. ...

ByPuzzle Medical Devices Inc.


Advanced Bifurcation Systems Announces First Closing of Series A Financing

Advanced Bifurcation Systems Announces First Closing of Series A Financing

Patients confronting coronary bifurcation lesions are currently left with only two options: either complex stenting procedures with suboptimal and unpredictable results, or higher risk and more expensive, open-heart surgery. The ABS System is specifically designed to efficiently treat coronary bifurcation lesions with predictable results. ...

ByAdvanced Bifurcation Systems


Cardiac Dimensions Announces Australian Therapeutic Goods Administration’s Approval of the Carillon System for the Treatment of Functional Mitral Regurgitation

Cardiac Dimensions Announces Australian Therapeutic Goods Administration’s Approval of the Carillon System for the Treatment of Functional Mitral Regurgitation

Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1:4–25. Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the Impact of Heart Failure in the United States. Circ Heart Fail. 2013;6(3):606-19. ...

ByCardiac Dimensions, Inc.


Colibri Heart Valve Forms a New Entity to Monetize Tissue Processing Technology in Applications Outside of Structural Heart

Colibri Heart Valve Forms a New Entity to Monetize Tissue Processing Technology in Applications Outside of Structural Heart

Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announces the formation of a new company called Colorado Therapeutics LLC. ...

ByColibri Heart Valve LLC


Colibri Heart Valve Forms a New Entity to Monetize Tissue Processing Technology in Applications Outside of Structural Heart

Colibri Heart Valve Forms a New Entity to Monetize Tissue Processing Technology in Applications Outside of Structural Heart

Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announces the formation of a new company called Colorado Therapeutics LLC. ...

ByColibri Heart Valve LLC


Kohl`s Cares(R) scholarship program accepting nominations February 1 - March 15, ten national winners to receive $10,000 each

Kohl`s Cares(R) scholarship program accepting nominations February 1 - March 15, ten national winners to receive $10,000 each

Last year's Kohl's Cares scholarship winners included 9-year-old Lily Toomey who has helped the American Heart Association raise $100,000 by sharing her personal story of a congenital heart defect and open heart surgery, 18-year-old Charles Dewey who started a literacy program for homeless children, and Carolyn Houlahan who ...

ByCSRwire - Corporate Social Responsibility Newswire

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