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...
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...
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 (...
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...
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.
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...
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,...
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...
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...
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...
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.
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...
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...
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...
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...
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...
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...
June 20, 2012 — Echocardiography is playing a key role in both the assessment and guidance of transcatheter aortic valve replacement (TAVR). Attendees at the American Society of...
June 15, 2012 — Cardiosolutions Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Dexterity Steerable Introducer, a next-generation...
June 15, 2012 — CardiAQ Valve Technologies (CardiAQ), which has developed the world’s first self-conforming and self-anchoring technology for nonsurgical transcatheter mitral valve implantation (...
June 14, 2012 — A U.S. Food and Drug Administration (FDA) advisory panel voted in favor of recommending expanding the indication for the Edwards Lifesciences Sapien...
June 4, 2012 — MitrAssist Medical Ltd., a developer of minimally invasive products for treating heart disease, announced today it received ISO 13485:2003 certification for the design and...
May 23, 2012 — Edwards Lifesciences Corp. announced that data from its post-approval study involving 94 European centers performing transcatheter aortic valve replacement (TAVR) demonstrated...
May 21, 2012 -- Boston Scientific Corp. announces results from the REPRISE I feasibility trial, which evaluated the acute safety of the Lotus Aortic Valve System in patients with severe...
May 15, 2012 — In a keynote Founders’ Lecture at the Society for Cardiovascular Angiography and Interventions (SCAI) 2012 Scientific Session on May 10, Ted Feldman, M.D., FSCAI, highlighted how...
May 4, 2012 - Edwards Lifesciences Corp. announced that new data from the European multi-center Triton trial studying the Edwards Intuity valve system highlights the promise of several important...
May 4, 2012 - SMT Research & Development Ltd. (SMT) announced the addition of three key executives to its management team, including a new CEO, CFO and chief medical officer, plus two...
May 1, 2012 – The Centers for Medicare and Medicaid Services (CMS) announced today it will now cover transcatheter aortic valve replacement (TAVR) for Medicare...
April 23, 2012 - Boston Scientific Corp. announces that it has completed enrollment in the REPRISE I clinical trial, which is designed to evaluate the acute safety of the Lotus Aortic Valve System...
April 20, 2012 — VasoStitch will be featuring its technology at EuroPCR, Europe’s largest interventional cardiology scientific meeting, May 17, in Paris.
April 19, 2012 - St. Jude Medical Inc., a global medical device company, announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and the launch of the Trifecta...
April 12, 2012 - Edwards Lifesciences Corp. said a U.S. Food and Drug Administration (FDA) advisory panel will review the company's request to expand the indication for the Sapien transcatheter...
April 4, 2012 — Edwards Lifesciences Corp. reported that longer-term results (≥ 2 years) from the high-risk Cohort A of the PARTNER Trial – a randomized comparison of patients treated with either...
Patients who underwent transcatheter aortic valve implantation (TAVI) at experienced medical centers had significant improvement in valve function as well as low mortality and stroke rates at 30...
March 29, 2012 — Non-cardiac co-morbidities such as chronic obstructive pulmonary disease, chronic kidney disease and frailty are the main predictors of late mortality after transcatheter aortic...
The American College of Cardiology (ACC) 2012 Scientific Session, held March 24-27 in Chicago, was the first major cardiology show this year for vendors to display their latest innovations. A...
GE Healthcare unveiled two recently U.S. Food and Drug Administration (FDA)-cleared angiography systems offering mobility and advanced imaging for interventional cardiology at the American College...
March 8, 2012 — Edwards Lifesciences Corp. reported March 3 it filed its official response to the Centers for Medicare and Medicaid Services (CMS) on its proposed national coverage determination (...
March 7, 2012 — Four leading heart organizations representing cardiologists and cardiothoracic surgeons released initial recommendations for creating and maintaining transcatheter aortic valve...
