Sorin Group has received U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application and clinical trial protocol to begin evaluating its Perceval S...
The development of 3-D transesophageal echo (TEE) just a few years ago has enabled a new generation of interventional procedures to be performed, which otherwise...
Live demonstration, transmission or recording of transcatheter aortic valve replacement (TAVR) has been found feasible and safe, even for the typically high-risk patients who undergo the procedure...
Multi-detector computed tomography (MDCT) is a better way to measure annular size in patients with aortic stenosis who are candidates for transcatheter aortic valve implantation (TAVI) than two...
Colibri Heart Valve LLC has successfully completed the first clinical use of the company's proprietary transcatheter aortic heart valve. The Colibri transcatheter aortic valve implantation (TAVI)...
NeoChord has received CE-mark for its technology that allows the implantation of artificial chordae tendinae, a proven technique for the repair of mitral valve prolapse, via a ...
An RTI International-developed prototype catheter that can generate live, streaming 3-D ultrasound images from inside the heart received a Cardiovascular Innovation Award at the 2013...
The Heart Failure 2013 LA meeting will include a showcase of several startup companies offering innovative new approaches to address heart and cardiovascular disease.
Abbott announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted by majority (Yes: 5, No: 3) that the benefits...
The three-year results of a pivotal clinical study comparing the Edwards Sapien transcatheter heart valve and open-heart surgery demonstrated comparable outcomes. These new data from The PARTNER...
Edwards Lifesciences Corporation announced that preliminary results from The PARTNER II Trial demonstrated similar one-year outcomes in mortality and major clinical events between the Edwards...
Boston Scientific reports preliminary data in the PREVAIL clinical trial met two out of three co-primary endpoints. The data was supposed to be presented during the 2013 American College of...
March 13, 2013 — St. Jude Medical Inc. announced the first patient implant in a new pivotal trial evaluating the company’s Amplatzer cardiac plug (ACP) for the prevention of stroke.
March 7, 2013 — A newly identified genetic variant doubles the risk of calcium buildup in the heart’s aortic valve. Calcium buildup is the most common cause of aortic stenosis, a narrowing of the...
March 7, 2013 — Philips Healthcare announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EchoNavigator live image-guidance tool.
Medtronic Inc. announced European CE (Conformité Européenne) mark approval for its Engager Transcatheter Aortic Valve Implantation (TAVI) System with transapical delivery catheter. The system...
Medtronic Inc. announced it received U.S. Food and Drug Administration (FDA) approval to conduct an early feasibility study using the Medtronic Native Outflow Tract Transcatheter Pulmonary Valve (...
The American Heart Association (AHA) is focusing its advocacy efforts across the Midwest on the use of pulse oximetry screening (pulse ox) to detect congenital heart defects in newborns.
CardioLogical Solutions is an emerging cardiovascular device company formed by the merger of Emboline and VasoStitch and its breakthrough platform of accessory devices for transcatheter aortic...
St. Jude Medical Inc announced the first patient implant of its 25 mm Portico Transcatheter Aortic Heart Valve using the Transfemoral Delivery System in its ongoing European trial. The Portico...
St. Jude Medical has issued a Class I recall for its Amplatzer TorqVue FX Delivery System used in transcatheter closure of atrial septal defects (ASDs). The company said in a small number of cases...
The Centers for Medicare and Medicaid Services (CMS) announced that more than 500 organizations will begin participating in the Bundled Payments for Care Improvement initiative. Through this new...
Direct Flow Medical Inc. has received CE mark for its distinctive transcatheter aortic heart valve with metal-free frame and low-profile transfemoral delivery system.
January 31, 2013 — Belgian biotechnology company Cardio3 BioSciences (C3BS) announced it has received authorization to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-...
St. Jude Medical Inc. announced European CE mark approval of its Amplatzer Amulet Left Atrial Appendage Occluder. The Amulet device is used to close the left atrial appendage (LAA) in patients...
To help identify trends and find out what DAIC readers are interested in, the magazine takes note of what they click on when visiting the website. Below are the top 25 stories from 2012, and the...
January 21, 2013 — ECRI Institute, a nonprofit organization that researches the best approaches to improving patient care, recently evaluated evidence behind the use of the only transcatheter...
CardioKinetix Inc. announced the enrollment of the first patients in PARACHUTE IV, the randomized pivotal U.S. trial of the minimally invasive Parachute Ventricular Partitioning Device for the...
Open heart surgery may be a dying art, as new valve replacement techniques offer life-changing treatment without the need for invasive procedures, states a new report by healthcare experts...
January 16, 2013 — CardioLogical Solutions, a new cardiovascular device company, announced it has initiated operations. CardioLogical Solutions represents the merger of two independent companies,...
April 27, 2012 — GE Healthcare, a unit of General Electric Company, announced the U.S. Food and Drug Administration (FDA) clearance and availability of the latest version of its Vivid E9...
CardiAQValve Technologies Inc. received $37.3 million in funding in its second round of equity financing. OrbiMed led the round and was joined by Versant Ventures, Advent Life Sciences and...
January 3, 2013 — BioVentrix announced it has received CE mark for its Revivent myocardial anchoring system, which makes possible Less Invasive Ventricular Enhancement (LIVE), a procedure...
The Society of Cardiovascular Computed Tomography (SCCT) announced the publication of the SCCT Expert Consensus Document on Computed Tomography Imaging Before Transcatheter Aortic Valve...
According to Millennium Research Group (MRG), approximately 80 percent of transcatheter aortic valve replacement (TAVR) procedures are being performed on high-risk patients who are ineligible for...
The past year in cardiology has continued to see progress and innovation in medicine. As the year comes to an end, the American College of Cardiology (ACC) identified some of the top...
Resuscitation, cell regeneration, a new high blood pressure treatment and developments in devices for treating stroke are among the key scientific findings that make up this year's top...
According to Millennium Research Group (MRG), a company focused on global medical technology market intelligence, approximately 80 percent of transcatheter aortic valve replacement (TAVR)...
The annual Transcatheter Cardiovascular Therapeutics (TCT) meeting brings many cutting-edge technologies to the forefront during its five days of clinical sessions. This is my editor’s choice of...
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that the anticoagulant Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke...
For functional mitral valve regurgitation, the results of open repair are poor, but the next generation of transcatheter heart valve repair technologies in development may offer new hope for these...
More than a million adult congenital heart disease patients in the United States will soon be able to choose a specialist who has demonstrated the unique knowledge and skills their care requires...
December 13, 2012 — St. Jude Medical Inc. announced the first patient implant of its 23 mm Portico transcatheter aortic heart valve using the transapical delivery system.
TeraRecon previewed a flexible new pay-as-you-go billing option for it cloud and laptop users of its iNtuition advanced visualization tools. The software supports physicians involved in TAVI/TAVR...
Medtronic Inc. announced the first treatment of a U.S. patient in its global, multicenter, randomized clinical trial comparing the Medtronic CoreValve system with surgical aortic valve replacement...
The U.S. Court of Appeals for the Federal Circuit affirmed an April 2010 federal jury decision that Medtronic CoreValve LLC is willfully infringing Edwards Lifesciences' U.S. Andersen...
Hospitals constantly try to predict what the future holds when planning new facilities and equipment purchases that need to last for the next decade. Martin Leon, M.D., attempted to answer that...
Medtronic Inc. announced new findings from the Medtronic CoreValve ADVANCE Study for one-year survival and health-related quality of life (HRQoL). The findings were presented at Transcatheter...
Edwards Lifesciences Corporation announced three-year results of a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards Sapien transcatheter heart...
Direct Flow Medical Inc. announced that its DISCOVER CE mark trial met its primary mortality endpoint. The study also demonstrated that greater than 95 percent of patients had mild or less aortic...
November 2, 2012 – A clinical trial that compared catheter-based PFO closure using an investigational device found that there was no significant reduction in ischemic and bleeding events compared...
Medtronic Inc. announced promising data from the Engager European Pivotal Trial for the investigational Medtronic Engager transcatheter aortic valve implantation (TAVI) system. The first results...
W. L. Gore & Associates (Gore) responded to initial results reported in St. Jude Medical Inc.’s RESPECT clinical trial. The RESPECT study investigated whether transcatheter closure of patent...
The Transcatheter Cardiovascular Therapeutics (TCT) conference showcases key advancements being made in interventional cardiology, focusing this year on the next generation of drug-eluting stents...
Edwards Lifesciences announced today it received approval from the United States Food and Drug Administration (FDA) to treat high-risk aortic stenosis patients with the Edwards Sapien...
October 12, 2012 — Boston Scientific announced it has enrolled the first patient in the REPRISE II clinical trial to evaluate the safety and performance of the Lotus valve system in up to 120...
Researchers at the University of Maryland School of Medicine, who are exploring novel ways to treat serious heart problems in children, have conducted the first direct comparison of the...
Medtronic Inc. announced it has received CE mark for its Medtronic CoreValve Evolut 23 mm valve, its latest self-expanding transcatheter aortic valve implantation (TAVI) system.
September 19, 2012 — In response to criticism by physicians about the restrictiveness of conditions put forth by the Center for Medicare and Medicaid Services (CMS) for reimbursement for...
September 18, 2012 — Neovasc Inc. announced that acute results from preclinical studies of its Tiara valve for the transcatheter treatment of mitral regurgitation were published in the ...
Cardiologists are restricting the use of transcatheter aortic valve implantation (TAVI) to very old or very sick patients at high surgical risk, according to research presented at the European...
The Cardiovascular Research Foundation (CRF) announced the late-breaking trials and first report investigations that will be presented at next month's...
Medtronic has reached two clinical program milestones for its CoreValve system in the United States. It completed enrollment in its study of high-risk patients in its CoreValve U.S. Pivotal...
August 17, 2012 —Xeridiem, a vertically integrated OEM that designs, develops and manufactures complex single-use medical devices, announced it will provide LoneStar Heart Inc. with...
Due to the increasing number of transcatheter aortic valve replacements (TAVR) and endovascular aneurysm repair (EVAR), a new startup company has developed a transfemoral combined access and...
Interventional procedures are growing rapidly and becoming more specialized in diverse areas of care. In the next decade, the number of people living in the United States who have heart...
Trends and new technology for cardiac computed tomography angiography (CCTA) were highlighted during the 2012 Society of Cardiovascular CT (SCCT) annual scientific meeting in July in Baltimore, Md...
July 23, 2012 — Medtronic Inc. announced the first patient enrollment in a clinical trial comparing the CoreValve system with surgical aortic valve replacement in patients with severe aortic...
July 16, 2012 — Cardiosolutions Inc., an early-stage company focused on the development of an innovative percutaneous system to treat patients with moderate to severe...
