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Condition: Heart Valve Disease
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MassDevice.com +5 | The top 5 medtech stories for April 13, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Toshiba partners with UCI to study potential brain damage in HS football players
Toshiba said yesterday it is partnering with the University of California, Irvine to study possible brain damage incurred in high school football ...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 5, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
Get this in your inbox everyday by subscribing to our newsletters.
5. Medtronic’s Resolute Integrity tops Abbott’s Xience | ACC 2016 roundup
Results from the Propel all-comers trial comparing Medtronic‘s Resolute Integrity drug-eluting stent showed it to be superior to the Xience stent made...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Edwards Lifesciences hits all-time high on Sapien 3 study
Shares in Edwards Lifesciences (NYSE:EW) hit an all-time high yesterday after the company reported strong 1-year data for its Sapien 3 replacement heart valve over the weekend.
Results from the Partner II trial from 1,077 intermediate-risk patients showed that the Sapien 3 beat surgical valve replacement across a variety of safety endpoints, Irvine, Calif.-based Edwards said at the American College of Cardiology’s annual meeting April 3. The combined all-cause death & disabling stroke rate was 8.4% for TAVR with Sapien 3 and 16.6% for the surgery arm, according to the study, which was also published in The Lan...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves Wall Street Beat American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news
Edwards Lifesciences touts intermediate-risk data for Sapien devices | ACC 2016
Data from a large trial of the Sapien line of replacement heart valves made by Edwards Lifesciences (NYSE:EW) are slated to be used to back bids for expanded indications in intermediate-risk patients.
Presented over the weekend at the American College of Cardiology’s annual meeting in Chicago, results from the Partner II trial involving the Sapien XT and Sapien 3 transcatheter aortic valve replacements compared the TAVR treatments with traditional open surgery in the intermediate-risk cohort (both of the Edwards valves are already approved in the U.S. for high-risk patients).
Sapien XT non-inferior to surgery at 2...
Source: Mass Device - April 4, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news
Medtronic launches CoreValve Evolut R trial in low-risk patients
Medtronic (NYSE:MDT) said yesterday that it launched another clinical trial for its CoreValve Evolut R replacement heart valve, aiming to win an expanded indication for low-risk patients.
The 1,200-patient trial is designed for patients with less than 3% risk of dying from open valve surgery, randomized to either transcatheter aortic valve replacement with the CoreValve device or surgical aortic valve replacement. It’s the 3rd trial for Medtronic’s TAVR offering since February, when the FDA approved the new investigational device exemption study.
The primary endpoint is all-cause mortality or disabling st...
Source: Mass Device - April 1, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Source Type: news
Colibri Heart Valve looks to raise $25m Series C for TAVR device
Colibri Heart Valve is looking to raise a $25 million Series C for the ready-to-use replacement heart valve it’s developing and has already put $1.25 million into its coffers.
Broomfield, Colo.-based Colibri is running a 1st-in-human trial of the transcatheter aortic valve replacement it’s developing, a pre-mounted, pre-crimped and pre-packaged device that’s designed to be shipped ready to use, according to its website.
Colibri has said that patients enrolled in the study showed no observed stroke, no pacemaker implantations, virtually no paravalvular leak and a high retained average effective orifice ...
Source: Mass Device - March 29, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Colibri Heart Valve Source Type: news
Imaging Techniques for Diagnosis of Thoracic Aortic Atherosclerosis.
Authors: Jansen Klomp WW, Brandon Bravo Bruinsma GJ, van 't Hof AW, Grandjean JG, Nierich AP
Abstract
The most severe complications after cardiac surgery are neurological complications including stroke which is often caused by emboli merging from atherosclerosis in the ascending aorta to the brain. Information about the thoracic aorta is crucial in reducing the embolization risk for both surgical open and closed chest procedures such as transaortic heart valve implantation. Several techniques are available to screen the ascending aorta, for example, transesophageal echocardiography (TEE), epiaortic ultrasound, TEE ...
Source: International Journal of Vascular Medicine - March 12, 2016 Category: Cardiology Tags: Int J Vasc Med Source Type: research
Transcatheter Aortic Valve Implantation in Patients at Extremely High Risk of Perioperative Mortality.
CONCLUSION: The data acquired verified that TAVI is a safe procedure, even in patients with an extremely high predicted risk of perioperative mortality and major adverse cardiac and cerebrovascular events. Furthermore, the analysis substantiated the need for individualized risk evaluation.
PMID: 26897844 [PubMed - in process]
Source: Journal of Heart Valve Disease - February 25, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research
A Comprehensive Fluid Dynamic and Geometric Study for an "In-Vitro" Comparison of Four Surgically Implanted Pericardial Stented Valves.
CONCLUSION: The study results combined the fluid dynamic reproducibility of the in-vitro setting and the specificity of surgery. A quantitative comparison of the fluid dynamic performance of the different bioprostheses was feasible.
PMID: 26897839 [PubMed - in process]
Source: Journal of Heart Valve Disease - February 25, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research
A Matched-Paired Comparative Analysis Ot tne Hemodynamics of the Trifecta and Perimount Aortic Bioprostheses.
CONCLUSION: Trifecta valve implantation is associated with a significant improvement in EOA and a decreased incidence of PPM as compared to the Perimount valve. The superior hemodynamic outcomes observed support consideration of this valve for aortic valve replacement, particularly in patients with a small LVOT at risk for PPM.
PMID: 26897822 [PubMed - in process]
Source: Journal of Heart Valve Disease - February 25, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research
Early and Late Outcomes After Minimally Invasive Mitral Valve Repair Surgery.
CONCLUSION: These data are the first from the U.K. demonstrating early and late outcomes after thoracoscopic assisted minimally invasive mitral valve repair surgery. The data establish the safety and efficacy of the technique and, importantly, lend further support towards a prospective randomized comparison of minimally invasive versus conventional mitral valve repair surgery.
PMID: 26897819 [PubMed - in process]
Source: Journal of Heart Valve Disease - February 25, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research
Myocardial and Cardiocirculatory Reserve in Asymptomatic Aortic Stenosis and Preserved Ejection Fraction.
CONCLUSION: Besides SWL and female gender, the EF after dobutamine as well as highest exercise stress intensity reached are helpful in determining the prognosis of asymptomatic patients with moderate-severe AS.
PMID: 26897816 [PubMed - in process]
Source: Journal of Heart Valve Disease - February 25, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research
Valve Replacement for Moderate Aortic Stenosis in Octogenarians Undergoing Revascularization.
CONCLUSION: In-hospital mortality is higher for octogenarians undergoing CABG+AVR compared to those undergoing isolated CABG. In the present study, a 'prophylactic' AVR was justified in patients with moderate AS, and their increased mortality (versus isolated CABG) was congruent with a higher preoperative co-morbid risk profile. Excellent long- term symptom-free survival further justifies 'prophylactic' AVR in octogenarians undergoing CABG with coexistent moderate AS.
PMID: 26897807 [PubMed - in process]
Source: Journal of Heart Valve Disease - February 25, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research
Mitral valve repair using robotic technology: Safe, effective, and durable
The most recent American College of Cardiology/American Heart Association heart valve guidelines recommend that prompt surgical correction of severe degenerative mitral valve regurgitation, ideally mitral valve repair, should be performed to decrease the risks of long-term mortality and heart failure risks associated with this condition. Mitral valve repair performed using a minimally invasive robotic approach can now be successfully carried out in nearly all cases of degenerative disease with very low risks of stroke or death.
Source: The Journal of Thoracic and Cardiovascular Surgery - February 22, 2016 Category: Cardiovascular & Thoracic Surgery Authors: Rakesh M. Suri, Joseph A. Dearani, Tomislav Mihaljevic, W. Randolph Chitwood, Douglas A. Murphy, Alfredo Trento, Hoda Javadikasgari, Harold M. Burkhart, Wiley L. Nifong, Richard C. Daly, A. Marc Gillinov Tags: Expert opinion Source Type: research
FDA approves trial for low-risk patients with MDT’s CoreValve Evolut R
This study is an important next step in developing robust clinical evidence to help heart teams understand the potential benefits of TAVR in a broader patient population.”
Earlier this month, the FDA granted an expanded indication for the CoreValve devices for patients with end-stage renal disease and low-grade, low-flow aortic stenosis.
The post FDA approves trial for low-risk patients with MDT’s CoreValve Evolut R appeared first on MassDevice.
Source: Mass Device - February 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
