November 3, 2010 – The first patient has been enrolled into a study comparing a left atrial appendage (LAA) closure device to warfarin therapy in those with atrial fibrillation. The PREVAIL study...
The first-in-man use of the Coherex WaveCrest left atrial appendage (LAA) occluder system was successfully performed recently in New Zealand, launching the WAVECREST 1 trial to evaluate the device...
October 25, 2010 – The Hague, Netherlands ruled in favor of Occlutech, a transcatheter structural heart occluder device maker, in the ongoing patent litigation with AGA Medical. The lawsuit stems...
St. Jude Medical Inc. said it plans to acquire AGA Medical Holdings Inc. for about $1.3 billion. The purchase will expand St. Jude’s cardiac device offerings with a portfolio of transcatheter...
October 15, 2010 – An investigational trial of Medtronic’s CoreValve transcatheter aortic valve has been approved by the U.S. Food and Drug Administration (FDA) today. The investigational device...
October 5, 2010 – Edwards Lifesciences has opened a new 300,000-square-foot facility in Draper, Utah, allowing the company to significantly expand its manufacturing and development capabilities,...
October 4, 2010 – Germany will reimburse patients who have a left atrial appendage closure procedure in 2011. The 2011 G-DRG (German Diagnosis Related Group) catalog, recently published on the...
September 29, 2010 – Physicians from the Cedars-Sinai Heart Institute will lead a clinical trial evaluating transcatheter aortic valve implantation (TAVI) for patients who experience severe aortic...
Transcatheter valve therapies were among the hottest topics at the 2010 Transcatheter Cardiovascular Therapeutics (TCT) symposium and the key presentation was the very positive first release of...
September 28, 2010 – The Transcatheter Cardiovascular Therapeutics (TCT) 2010 symposium featured a live case broadcast of a physician implanting a new device to treat refractory angina.
September 24, 2010 - The U.S. Food and Drug Administration (FDA) has granted conditional approval to start a trial testing a new treatment to reduce the incidence of new onset postoperative atrial...
September 23, 2010 – The U.S. Food and Drug Administration (FDA) has conditionally approved the first part of a trial testing a new transcatheter heart valve.
September 23, 2010 - The first-in-human procedure to use ultrasound therapy to treat mitral regurgitation (MR) has been successfully completed. The data from the study, which used ReCor Medical’s...
September 23, 2010 – The first consensus document for treating structural heart disease has been published by the Society for Cardiovascular Angiography and Interventions (SCAI).
September 17, 2010 - An aortic valve has been successfully implanted in the acute porcine model by Transcatheter Technologies GmbH (TT) using its Trinity system.
September 16, 2010 – A new collection of software applications for structural heart treatment under angiography will be highlighted by GE Healthcare during the 2010 Transcatheter Cardiovascular...
September 15, 2010 – Results from the PARTNER Trial Cohort B will be presented at 11 a.m. on Thursday, Sept. 23, at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 scientific symposium in...
September 14, 2010 – Transcatheter valves, drug-eluting balloons and the latest stent comparison trial data are among the top three trends at Transcatheter Cardiovascular Therapeutics (TCT) 2010...
September 7, 2010 – European CE mark approval was granted for a new Medtronic CoreValve delivery system with AccuTrak Stability Layer for transcatheter aortic valve implantation (TAVI). AccuTrak...
September 2, 2010 - The STAR-heart study, which was presented at the European Society of Cardiology 2010 Congress in August 2010, reported that the intracoronary injection of autologous stem cells...
August 25, 2010 – Alleging infringement of a patent for its transcatheter cardiac septal occluder devices, AGA Medical Holdings Inc. said it filed a lawsuit against W.L. Gore & Associates.
August 25, 2010 – There will be special tracks available for nurses and technologists and for the transcatheter treatment of patent foramen ovale (PFO) during the Transcatheter Cardiovascular...
August 19, 2010 – The 12-month follow-up results from the TITAN trial of the Carillon Mitral Contour System will be presented Aug. 29 at the European Society of Cardiology 2010 Congress (ESC) in...
August 12, 2010 – A 52-year-old male heart failure patient in Krakow, Poland, became the first human to receive the PliCath HF System for an epicardial catheter-based ventricular reconstruction (...
August 11, 2010 – New sizes of the SoloPath TransFemoral Endovascular Access Catheter were recently cleared by the U.S. Food and Drug Administration (FDA). The new sizes provide the potential to...
August 9, 2010 – A merger is being finalized between Medtronic and cardiac surgery device maker ATS Medical. The company develops and manufactures products and services for the treatment of...
Heart failure is a progressively debilitating disease that dramatically decreases the life expectancy and quality of life of affected patients. Nearly 5.8 million Americans are diagnosed with...
July 16, 2010 – A new extracellular matrix (ECM) biomaterial device recently received a CE mark, meaning it can now be marketed in European Union countries. The CorMatrix ECM for Cardiac Tissue...
July 14, 2010 – A Belgian biotechnology company recently announced positive safety data and preliminary efficacy results from a clinical trial of its new stem cell therapy for heart failure.
July 9, 2010 – W. L. Gore and Associates announced today that they are confident in the design and anticipated results of the Gore REDUCE Clinical Study, which was designed to test the safety and...
June 17, 2010 – AGA Medical Holdings Inc. this week announced first patient enrollment in the feasibility phase of the prospective, multicenter, randomized Amplatzer Cardiac Plug clinical trial....
June 16, 2010 – A new surgical device for excluding the left atrial appendage has received clearance from the U.S. Food and Drug Administration (FDA). AtriCure Inc. announced this week that it...
June 4, 2010 – One-year mortality rates were very low for 1,038 high-risk patients, many of whom were too sick to undergo traditional open-heart surgery, who received the Sapien transcatheter...
May 27, 2010 – New European data from five national clinical registries presented this week at EuroPCR in Paris report positive clinical outcomes for the transcatheter aortic valve implantation...
May 21, 2010 – The first successful transcatheter mitral valve implantation (TMVI) for a new mitral valve technology will be highlighted at the EuroPCR 2010 scientific meeting in Paris. A...
May 20, 2010 – An aortic embolic protection device, which acts as a protective shield to reduce the incidence of embolization to the brain, was granted CE mark approval this week in Europe. The...
May 10, 2010 – A catheter-based procedure is providing relief to patients who suffer from shortness of breath and fluid overload as the result of a severely leaky heart valve, but who are too sick...
April 2, 2010 – A federal jury yesterday found Medtronic’s CoreValve transcatheter aortic valve willfully infringes on patents owned by Edwards Lifesciences.
March 29, 2010 – A lawsuit was settled between Medtronic and AGA Medical Corp. for the alleged infringement of patents concerning the use of stress to restrain self-expanding nitinol medical...
March 25, 2010 – The FDA this week granted permission for a conditional investigational device exemption (IDE) to evaluate the safety and efficacy of a transcatheter plug to seal the left atrial...
March 16, 2010 — Several new initiatives in a robust international clinical program for a transcatheter aortic valve system have been set in motion with the goal of expanding the evidence base for...
March 14, 2010 — Late-breaking data presented at the American College of Cardiology's 59th annual scientific session from the landmark EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy)...
March 2, 2010 — A surgical valve has earned the European market clearance nod, marking the manufacturer's launch into the market for pericardial aortic stented tissue valves.
February 11, 2010 — An appeals court in Germany found the CoreValve transcatheter aortic valve system does not infringe Edwards Lifesciences’ German Andersen patent used in its SAPIEN aortic valve...
Jan. 25, 2010 — The first commercial implants of the ATS 3f Enable Aortic Bioprosthesis were recently performed at the University of Berne Hospital, Berne, Switzerland by Lars Englberger, M.D.,...
January 25, 2010 - In a significant development in treating congenital heart disease, the Medtronic Melody Transcatheter Pulmonary Valve today became the first transcatheter valve approved for use...
January 25, 2010 – First-in-man procedures and a feasibility study in Europe were recently initiated for a new minimally invasive aortic valve surgery system.
January 21, 2010 – The Federal Patent Court in Munich, Germany upheld the validity of Edward Lifesciences' patent for transcatheter valve technology and dismissed invalidity claims by competitor...
January 19, 2010 – A new simulator released today provides physicians with an opportunity to practice transcatheter heart valve implantation using a new module for the ANGIO Mentor simulator – the...
January 13, 2010 – Transcatheter heart valve development company CardiAQ Valve Technologies (CVT) closed a $6.5 million funding deal to clinically validate its technology and carry the company...
January 5, 2010 – St. Paul’s Hospital in Vancouver, Canada recently was the first to use the Embrella Embolic Deflector cerebral protection system. The device uses a porous membrane to deflect...
January 4, 2010 – The FDA's permission is sought to allow a safety and feasibility trial for the PHOENIX System, which allows tissue stimulation and injections of biologic or pharmacologic agents...
December 16, 2009 – Patient enrollment was recently completed for a study evaluating the ability of cardiopoietic cells to restore cardiac function in heart failure patients.
December 10, 2009 – An exclusive license agreement between On-X Life Technologies and the Cleveland Clinic will create a system of products intended to improve and simplify the replacement of...
November 21, 2009 — A drug used to treat erectile dysfunction may improve heart function in children and young adults with single ventricle congenital heart disease, according to researchers from...
November 13, 2009 – A 48-patient IDE clinical trial conducted at seven sites in the U.S. and one site in India using the Harvest Technologies’ Bone Marrow Aspiration Concentrate (BMAC) System to...
November 6, 2009 – Edwards Lifesciences Corp. today announced the first successful Japanese implants of a transcatheter aortic heart valve using its Edwards SAPIEN valve.
November 2, 2009 — Clinical trial results published in this week’s Journal of the American College of Cardiology (JACC) describe six-month outcomes for patients using the Melody Transcatheter...
October 22, 2009 – A study in the Oct. 27 issue of the Journal of the American College of Cardiology reports early positive results of implanting the Melody transcatheter pulmonary valve through a...
October 19, 2009 – iMobileHealth yesterday launched the iAorticValve Web site and iPhone application to allow doctors and patients to access and use critical aortic valve information and have it...
October 16, 2009 – The Clinical Center of Serbia, Institute for Cardiovascular Diseases today said it treated its first patient with a revolutionary cell-based therapy for heart failure.
October 13, 2009 – By mimicking the way embryonic stem cells develop into heart muscle in a lab, Duke University bioengineers believe they have taken an important first step toward growing a...
October 8, 2009 – A five-judge panel in the German Federal Patent Court in Munich upheld the validity of an AGA Medical Holdings’ patent for its AMPLATZER occlusion devices and the manufacturing...
October 6, 2009 – Direct Flow Medical Inc. released its One-year data from the initial clinical trial for its transcatheter prosthetic aortic valve during the recent Transcatheter Cardiovascular...
October 1, 2009 – Transcatheter heart valve company CardiAQ Valve Technologies (CVT), which is developing the world’s first self-conforming and self-anchoring technology for transcatheter mitral...
September 29, 2009 – Mardil Inc. last week at TCT 2009 announced positive interim data from a pilot study investigating the safety and efficacy of its novel cardiac device – BACE (Basal...
September 21, 2009 – Edwards Lifesciences Corp. today announced new clinical data demonstrating 100 percent freedom from structural deterioration of the Edwards SAPIEN valve at 18 months, as well...
September 17, 2009 – NMT Medical Inc. said yesterday it will commence data analysis for its landmark STARFlex patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) clinical trial,...
September 17, 2009 – One of the activities at TCT 2009 is the Hearts in Hand Collection, a library of physical heart models in a variety of structural disease states, which allow physicians to...
September 16, 2009 – Guided Delivery Systems Inc. (GDS) announced the first successful percutaneous implantation of the GDS Accucinch System for mitral valve repair.
