Persistent Mitral Regurgitation After TAVR Bodes Ill in Some Persistent Mitral Regurgitation After TAVR Bodes Ill in Some
Patients with low-flow, low-gradient aortic stenosis (LFLG-AS) who don't show improvement in mitral regurgitation following transcatheter aortic-valve replacement (TAVR) face an increased risk of mortality, according to a substudy of a multicenter registry.Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - February 26, 2020 Category: Radiology Tags: Cardiology News Source Type: news

Five-Year Outcomes Comparable for TAVR, Surgical AVR
TUESDAY, Feb. 4, 2020 -- There is no significant difference in the incidence of death or disabling stroke at five years among patients with aortic stenosis at intermediate surgical risk who undergo transcatheter aortic valve replacement (TAVR) or... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 4, 2020 Category: Pharmaceuticals Source Type: news

RECOVERY: Early Surgery Best in Severe Asymptomatic AS? RECOVERY: Early Surgery Best in Severe Asymptomatic AS?
In asymptomatic patients with very severe aortic stenosis, early aortic valve replacement surgery was associated with lower mortality than a more conservative course.Medscape Medical News (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - November 19, 2019 Category: Intensive Care Tags: Cardiology News Source Type: news

Mandrola Previews 2019 AHA and the ISCHEMIA Trial Mandrola Previews 2019 AHA and the ISCHEMIA Trial
All eyes will be on ISCHEMIA in Philadelphia, but a study on asymptomatic aortic stenosis as well as trials in heart failure and cardiogenic shock also piqued Dr John Mandrola's interest.theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 12, 2019 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news

Edwards SAPIEN 3 TAVI Receives Expanded Approval In Europe
Superior TAVI Valve Indicated for All Patients Diagnosed with Aortic Stenosis IRVINE, Calif., Nov. 6, 2019 -- (Healthcare Sales & Marketing Network) -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for st... Devices, Interventional, Cardiology, Regulatory Edwards Lifesciences, SAPIEN 3, transcatheter, heart valve, aortic valve (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 6, 2019 Category: Pharmaceuticals Source Type: news

TAVR-Surgery Parity at 5 Years, Good Echo Result Key: PARTNER 2A TAVR-Surgery Parity at 5 Years, Good Echo Result Key: PARTNER 2A
Late outcomes were similar to 2-year results; worse-than-mild paravalvular leaks after either procedure meant a much worse prognosis in these intermediate-risk patients with severe aortic stenosis.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - October 3, 2019 Category: Cardiology Tags: Cardiology News Source Type: news

Medtronic Wins Nod for TAVR System Ahead of TCT 2019
Medtronic has won a nod from FDA for the Evolut PRO+ TAVR System – a next-generation transcatheter aortic valve replacement system. The agency’s approval of the device comes just a few days before – TCT 2019. Plans call for the Dublin-based company to launch the product, which builds off the self-expanding, supra-annular Evolut TAVR platform. The Evolut PRO+ TAVR System can treat the broadest annulus range and offers the lowest delivery profile on the market (the 23, 26- and 29-mm valves can treat vessels down to 5.0 mm). Evolut PRO+ features four-valve sizes â...
Source: MDDI - September 24, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

New Expanded Indication Could Change the TAVR Narrative
The transcatheter aortic valve replacement market received one of the biggest jolts of the year when FDA expanded indications of both Edwards Lifesciences and Medtronic’s valves. FDA’s measure would open up the valves to be used in younger and low-risk patients. The agency said these transcatheter valves – Edwards’ Sapien 3, and Sapien 3 Ultra, with Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications duri...
Source: MDDI - August 20, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news

How 2019 Will Define TAVR for Years to Come
There have been some pretty significant developments in the transcatheter aortic valve replacement market over the past few months. It’s safe to say it’s not going to be business as usual for TAVR in the coming years. One of the biggest developments in the market was FDA’s approval of Boston Scientific’s Lotus Edge valve in April. The approval did not come as a shock as the Marlborough, MA-based company communicated in August of 2018 that the nod from FDA would come near the middle of 2019. The approval was truly a game-changer because it meant there w...
Source: MDDI - August 6, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

TAVI with SAPIEN 3 cost effective vs surgery for aortic stenosis
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - August 1, 2019 Category: Drugs & Pharmacology Source Type: news

Edwards Drops Centera to Focus on Sapien 3 Ultra
Edwards Lifesciences said it is discontinuing work on its Centera Transcatheter Aortic Valve system. The Irvine, CA-based company said it will instead turn its attention and energy to the Sapien 3 Ultra Valve. The news came during Edwards’ 2Q19 earnings call. The TAVR pioneer said the reason for halting the Centera program was due to the costs associated with expanding its indications to match the Sapien 3 valve. “Given the pending approval for patients at low risk and the continued excellence and versatility of our balloon-expandable platform, we have made the difficult decision to disc...
Source: MDDI - July 25, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

High Systolic BP Causes Valve Disease, Genetic Study Suggests High Systolic BP Causes Valve Disease, Genetic Study Suggests
Going beyond prior observational studies, a Mendelian randomization analysis provides strong evidence that raised systolic blood pressure leads to aortic stenosis and other valve disorders.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - July 18, 2019 Category: Cardiology Tags: Neurology & Neurosurgery News Source Type: news

Eko Employs AI to Help in Detection of Aortic Stenosis
Eko, a digital health company is using artificial intelligence and machine learning to aid in the fight against heart disease. The Berkley, CA-based company recently unveiled its Aortic Stenosis (AS) detection algorithm at the American Society of Echocardiography (ASE) 2019 Scientific Sessions. The algorithm was developed and tested in partnership with the Northwestern Medicine Bluhm Cardiovascular Institute. It is significant and stands to be more objective application than current detection methods for AS. The disease is often initially identified during the physical exam when a provider hears a heart murmur using his or...
Source: MDDI - June 28, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

TAVR Speedier Stenosis Fix Than SAVR in Patients With Prior CABG TAVR Speedier Stenosis Fix Than SAVR in Patients With Prior CABG
In patients who have previously undergone coronary-artery bypass grafting (CABG) and have symptomatic aortic stenosis (AS), transcatheter aortic-valve replacement (TAVR) using the Medtronic Corevalve System may offer advantages over surgical aortic-valve replacement (SAVR).Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - June 28, 2019 Category: Surgery Tags: Cardiology News Source Type: news

Final CMS Decision on TAVR Reimbursement Final CMS Decision on TAVR Reimbursement
CMS revises thresholds set for hospitals to qualify and maintain Medicare payment for TAVR amid rising interest in this approach to aortic stenosis.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 25, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news

Mortality No Different With TAVR for Bicuspid, Tricuspid Stenosis
TUESDAY, June 11, 2019 -- For patients undergoing transcatheter aortic valve replacement (TAVR) for aortic stenosis, there is no significant difference in 30-day or one-year mortality for bicuspid or tricuspid aortic stenosis, according to a study... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 11, 2019 Category: Pharmaceuticals Source Type: news

May 31 2019 This Week in Cardiology May 31 2019 This Week in Cardiology
Tricuspid valve repair, aortic stenosis, His-bundle pacing, deprescribing loop diuretics, and ‘ leakage ’ are covered in this week ’ s podcast.theheart.org on Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - May 31, 2019 Category: Cardiology Tags: Cardiology Commentary Source Type: news

Could a Biomarker Take AVR to the New Aortic Stenosis Frontier? Could a Biomarker Take AVR to the New Aortic Stenosis Frontier?
Mortality climbs for patients with severe aortic stenosis who don't get a valve replacement because they are asymptomatic, especially if their natriuretic peptides are elevated, an analysis suggests.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - May 29, 2019 Category: Cardiology Tags: Cardiology News Source Type: news

PCR statement on evolving indications for transcatheter aortic valve implantation
(PCR) Paris, France, 21 May 2019. Severe symptomatic aortic stenosis, a degenerative disease-causing calcification and immobility of the aortic valve leaflets leading to left ventricular outflow obstruction, is the most common valve lesion leading to intervention in Europe and the USA. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 17, 2019 Category: International Medicine & Public Health Source Type: news

Lp(a) Pegged as Aortic Stenosis Culprit and Treatment Target Lp(a) Pegged as Aortic Stenosis Culprit and Treatment Target
Serial imaging showed it, and a lab experiment nailed it — at least in vitro. Elevations in two biomarkers further the progression of aortic valve calcification, and their inhibition might thwart it.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 3, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news

In Severe, Asymptomatic Aortic Stenosis, Early Surgery May Help
TUESDAY, April 23, 2019 -- Early aortic valve replacement (AVR) may improve survival in patients with severe, asymptomatic aortic stenosis, according to a study published online March 20 in The Annals of Thoracic Surgery. John Campo, M.D., of the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 23, 2019 Category: Pharmaceuticals Source Type: news

TAVR Puts the Swagger Back in Mick Jagger
Rolling Stones frontman Mick Jagger’s recent surgery is putting a huge spotlight on the transcatheter aortic valve replacement (TAVR) market. Late last week, Jagger tweeted that his procedure was a success and thanked fans for their support.   Thank you everyone for all your messages of support, I’m feeling much better now and on the mend - and also a huge thank you to all the hospital staff for doing a superb job. — Mick Jagger (@MickJagger) April 5, 2019 Problems for the 75-year-old began late last month after the rocker fell ill. As a result, the Rolling...
Source: MDDI - April 10, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Mick Jagger is giving TAVR a boost: Here ’ s how
Mick Jagger during a concert in Warsaw, Poland in 2018 [Image by Jerzy Bednarski – Own work, CC BY-SA 4.0]A successful transcatheter aortic valve replacement (TAVR) recovery for rock icon Mick Jagger could be good news for companies such as Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) that make devices for the procedure, according to analysts following the medical device industry. The Rolling Stone frontman tweeted Friday that he was feeling better and on the mend after undergoing the procedure at a New York hospital. “We think Mick Jagger’s TAVR procedure will likely raise awareness of aortic ...
Source: Mass Device - April 8, 2019 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Cardiovascular Featured News Well Edwards Lifesciences Medtronic tavr Source Type: news

What Will a'Historic Day' for TAVR Mean in Clinical Practice? What Will a'Historic Day' for TAVR Mean in Clinical Practice?
Raj Makkar, MD, discusses the PARTNER-3 and Evolut trials of transcatheter aortic valve replacement in low-surgical-risk patients and his registry data on TAVR for bicuspid aortic stenosis at ACC.19.theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 25, 2019 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news

Aortic Stenosis: Watchful Waiting Works Only for So Long
(MedPage Today) -- Study supports timely aortic valve replacement in asymptomatic patients (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - March 23, 2019 Category: Cardiology Source Type: news

ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology. Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine. Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at ...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news

TAVR With Evolut: Interim Results Promising in Low-Risk Patients TAVR With Evolut: Interim Results Promising in Low-Risk Patients
The transcatheter procedure was noninferior to surgery in an interim Bayesian analysis of the primary endpoint -- death from any cause or disabling stroke at 24 months -- in a new trial involving patients with severe aortic stenosis at low surgical risk.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 16, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news

PARTNER 3: TAVR Success in Low-Risk Patients PARTNER 3: TAVR Success in Low-Risk Patients
The procedure using the SAPIEN 3 valve showed a significantly lower rate of death, stroke, and rehospitalization at 1 year vs surgery in patients with severe aortic stenosis at low surgical risk.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 16, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news

Mandrola Previews the 2019 ACC Meeting Mandrola Previews the 2019 ACC Meeting
The Apple Heart Study will hog the spotlight, but trials on TAVR in low-risk aortic stenosis are more likely to affect practice, says digital-health skeptic John Mandrola, MD. Linkstheheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 12, 2019 Category: Consumer Health News Tags: Cardiology Expert Column Source Type: news

Study of Boston Scientific ’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years
Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products. The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system. Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices. Patients, treated between Se...
Source: Mass Device - February 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves Boston Scientific Medtronic Source Type: news

Medical News Today: Study ties arthritis pain reliever to heart valve disease
An analysis of 8,600 electronic medical records has found a specific link between the use of the NSAID celecoxib (Celebrex) and aortic stenosis. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - February 26, 2019 Category: Consumer Health News Tags: Osteoarthritis Source Type: news

Long-term Durability of TAVR Encouraging: NOTION, UK TAVI Long-term Durability of TAVR Encouraging: NOTION, UK TAVI
Transcatheter valve replacement is increasingly being used as an alternative to surgical replacement in severe aortic stenosis, but how durable is it? Two studies provide reassuring findings.Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 13, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news

TAVR for Intermediate-Risk Severe Aortic Stenosis? TAVR for Intermediate-Risk Severe Aortic Stenosis?
Recent data supports a less invasive strategy for aortic valve intervention with a TAVR approach in the majority of intermediate-risk patients with calcific aortic stenosis.Circulation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 5, 2019 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

JenaValve names Kilcoyne as CEO | Personnel Moves – January 15, 2019
JenaValve Technology said today that it named former ReVision Optics prez & CEO John Kilcoyne as its new chief executive officer, effective immediately, replacing Dr. Victoria Carr-Brendell, who has taken up an executive leadership position with Sonova Holding AG (SIX:SOON). Prior to his time at ReVision Optics, Kilcoyne served as prez & CEO at Micrus Endovascular where he led the company through an initial public offering in 2005 and an acquisition by Johnson & Johnson in 2010. He has also held positions at Solace Therapeutics and Endonetics, Irvine, Calif.-based JenaValve said. “I am plea...
Source: Mass Device - January 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured apyxmedical biogennix Cardiac Dimensions Cardiovascular Systems Inc. Coorstek Covidien DaVita Inc. Digirad Corp. Endologix ev3 Inc. Integra LifeSciences Intuitive Surgical InVivo Therapeutics Source Type: news

Jan 4 2019 This Week in Cardiology Jan 4 2019 This Week in Cardiology
The cost of treating high blood pressure, heart-failure readmission policies, abdominal fat, low flow/low gradient aortic stenosis and hypertensive disorders of pregnancy are discussed this week.theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 4, 2019 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news

Edwards' SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval
Irvine, Calif., Dec. 28, 2018 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration (FDA) approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery....This story is related to the following:Surgical Implants (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - January 2, 2019 Category: Medical Devices Source Type: news

FDA gives Edwards ’ Sapien 3 Ultra TAVR the nod
Edwards Lifesciences (NYSE:EW) can now market its Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) device in the United States. The FDA approved the device for severe, symptomatic aortic stenosis patients for whom open-heart surgery is considered an intermediate or greater risk, the Irvine, Calif.-based company said. For the Ultra, Edwards has added a taller skirt with sizes 20, 23 and 26 mm to the Sapien 3 design to eliminate paravalvular leak and improve TAVR outcomes. The Ultra device also introduces an “on balloon” design that the company said does away with the need for valve alignmen...
Source: Mass Device - December 28, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Food & Drug Administration (FDA) News Well Replacement Heart Valves Boston Scientific Edwards Lifesciences Source Type: news

TAVR Helpful Irrespective of LV Dysfunction and Contractile Reserve TAVR Helpful Irrespective of LV Dysfunction and Contractile Reserve
Transcatheter aortic valve replacement (TAVR) is beneficial even in patients with low-flow, low-gradient aortic stenosis and severe left ventricular dysfunction, according to North American and European researchers.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 27, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Edwards Lifesciences, Bay Labs ink cardio-focused collab AI-dev deal
Edwards Lifesciences’ (NYSE:EW) and  cardiovascular artificial intelligence medtech firm Bay Labs, have inked a multi-faceted collaborative cardiovascular-focused development deal, Bay Labs said today. San Francisco-based Bay Labs said that the partnership involves multiple initiatives including the development of new AI-powered algorithms in Bay Labs’ EchoMD software suite and the integration of EchoMD algorithms into Edwards’ CardioCare quality care navigation platform, as well as support for ongoing clinical studies. “Our vision is to improve patient care throughout the continuum from d...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Research & Development baylabs Edwards Lifesciences Source Type: news

Meril Life Sciences wins approval for TAVR in India
Meril Life Sciences’ MyVal TAVR device Indian medtech maker Meril Life Sciences has won regulatory approval for a transcatheter aortic valve replacement (TAVR) developed exclusively in India, according to a published report. The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells offer high radial strength, according to the company’s website. India’s Central Drugs Standard Control Organisation granted the MyVal device approval for commercialization last month, according to a r...
Source: Mass Device - December 7, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Central Drugs  Standard Control Organisation Meril Life Science Source Type: news

Is 2019 Going to Be a Standout Year for TAVR?
JenaValve has won a nod from FDA for expanded IDE enrollment of its transcatheter aortic valve replacement (TAVR) system. The agency’s nod is aimed at feasibility studies for the JenaValve Pericardial TAVR System with the Everdur transcatheter heart valve and expands eligible enrollment from 20 patients to 80 at high or extreme surgical risk. The Irvine, CA-based company said the prospective IDE studies are part of a larger, ongoing CE Mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers of excellence in Europe and New Zealand. Approval for addition...
Source: MDDI - December 4, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Pivotal trial kicks off for Edwards Lifesciences ’ Pascal mitral repair device
A pivotal trial of Edwards Lifesciences’ (NYSE:EW)Pascal mitral valve repair system is now underway, with the first procedure being performed this week at Atlantic Health System’s Morristown Medical Center, the group said. The study, dubbed the Clasp IID trial, will explore the safety and efficacy of Irvine, Calif.-based company’s Pascal TMVR system in treating patients with degenerative mitral valve regurgitation, the research institution said. “As a nationally ranked heart hospital, Morristown Medical Center is proud to be the first hospital in the world to implant this device as part of this...
Source: Mass Device - December 4, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Source Type: news

Lipoprotein(a) Shows Linear Link With Aortic-Stenosis Progression Lipoprotein(a) Shows Linear Link With Aortic-Stenosis Progression
Elevated levels of lipoprotein(a) -Lp(a) - and associated compounds are tied to a higher rate of calcific aortic-valve stenosis (CAVS), according to a secondary analysis of trial data.Reuters Health Information (Source: Medscape Pathology Headlines)
Source: Medscape Pathology Headlines - December 4, 2018 Category: Pathology Tags: Cardiology News Source Type: news

FDA OKs expanded JenaValve study
JenaValve Technology said today that the FDA approved the expansion of its investigational device exemption trials for the transcatheter aortic valve replacement it’s developing. The JenaValve system consists of the Everdur valve and Coronatix delivery catheter. The FDA decision expands the feasibility study from 20 extreme- or high-risk patients to 80 patients with either aortic stenosis or aortic regurgitation, the Irvine, Calif.-based company said. JenaValve said the IDE studies are part of its larger CE Mark program in Europe and New Zealand. “We are extremely pleased with the initial clinica...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Featured Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves JenaValve Source Type: news

Nov 30, 2018 This Week in Cardiology Nov 30, 2018 This Week in Cardiology
TAVR vs surgery for high-risk aortic stenosis, conflicts of interest for physicians and societies, spin in the CV literature, and low-carb diets are discussed in this week ’ s podcast.theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 30, 2018 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news

Asymptomatic Severe Aortic Stenosis in Individuals > 80 Years Asymptomatic Severe Aortic Stenosis in Individuals > 80 Years
Should asymptomatic severe aortic stenosis be treated in the very old?Journal of the American Geriatrics Society (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 29, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Survival and Stroke Similar for TAVR and SAVR at 5 Years Survival and Stroke Similar for TAVR and SAVR at 5 Years
The early mortality benefit seen with transcatheter aortic valve replacement over surgical repair in patients with severe aortic stenosis at high surgical risk is no longer significant at 5 years.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 26, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Edwards & #039; Sapien 3 Ultra Valve Wins CE Mark
As expected, Edwards Lifesciences has secured a CE mark for its Sapien 3 Ultra device, but the company won't be able to release the new transcatheter aortic valve replacement (TAVR) system in Germany due to a recent preliminary injunction from Boston Scientific. The CE mark allows Edwards to market the device in Europe for patients with severe, symptomatic aortic stenosis. "Edwards is disappointed in Boston Scientific's tactic to limit access of this new therapy," the company said in a press release. The Germany case involves a European patent  Boston Scientific acquired in 2017 when it bo...
Source: MDDI - November 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis. Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival Boston Scientific (NYSE:BSX). The company said that “the German court will hold a full hearing on the merits of the dispute” mid-next year, and that it is hopeful it will prevail. The company said it will introduce the Sapien 3 Ultra in the rest of Euro...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

SURTAVI: Fewer Early Strokes, Better QOL With TAVR vs SAVR SURTAVI: Fewer Early Strokes, Better QOL With TAVR vs SAVR
Intermediate-risk patients with aortic stenosis are usually treated with SAVR, but new data suggest TAVR may be more effective in preventing early strokes and improving quality of life.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - October 30, 2018 Category: Neurology Tags: Cardiology News Source Type: news