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

Edwards Lifesciences posts mixed bag Q3 earnings
Edwards Lifesciences (NYSE:EW) today posted third quarter earnings that topped earnings per share consensus on Wall Street but missed on revenue expectations. The Irvine, Calif.-based company posted profits of $225.9 million, or $1.08 per share, on sales of $906.6 million for the three months ended September 30, seeing the bottom line grow 32.8% while sales grew 10.4% when compared to the same period during the previous year. Adjusted to exclude one-time items, earnings per share were 1.07¢, just ahead of the $1.02 consensus on The Street, where analysts were looking for sales of $928.2 million, which the co...
Source: Mass Device - October 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Edwards Lifesciences Source Type: news

Early AVR in Asymptomatic Severe Aortic Stenosis: New Support Early AVR in Asymptomatic Severe Aortic Stenosis: New Support
' We think it should be a class I recommendation'that such patients with certain echocardiographic risk markers be considered for surgical or transcatheter aortic valve replacement, said a researcher.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 10, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

‘ Take Action ’ : Dave McGillivray ’s Message To Anyone Ignoring Symptoms Of Heart Disease
BOSTON (CBS) – There aren’t many people who run their age in miles every year. Dave McGillivray does. From the time he was a boy, he’s celebrated his good health and love of running with a personal challenge that obviously gets more challenging with age. His last “full” birthday run was last year: 63 miles. This year, by necessity, he split the effort into 32 miles of running and 32 miles of biking. A feat, to be sure. But this year, he is facing a challenge for which there is no training. McGillivray, arguably one of the most fit people on the planet, has coronary artery disease and is prepa...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - October 9, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Health Seen On WBZ-TV Syndicated Local Watch Listen Dave McGillivray Lisa Hughes Mass General Hospital Source Type: news

Edwards launches US pivotal Centera self-expanding TAVR study
Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Edwards said. The Irvine, Calif.-based company said it hopes to enroll approximately 1,000 patients in the trial, which will include a bicuspid registry. The endpoin...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news

Silent Aortic Stenosis Outcomes Good With Close Surveillance
(MedPage Today) -- Midterm survival rates high with medical management in registry (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - October 3, 2018 Category: Cardiology Source Type: news

One-Year Results from Real-World Study Showed Abbott's Portico ™ Transcatheter Aortic Valve Safely and Successfully Reduced Severe Aortic Stenosis
- Late-breaking data from real-world experience with the first fully repositionable and retrievable valve were consistent with previous results, and support that Portico can be successfully used in various anatomies in a real-world setting (Source: Abbott.com)
Source: Abbott.com - September 25, 2018 Category: Pharmaceuticals Source Type: news

Medtronic Will Study TAVR in Low-Risk Patients with Bicuspid Valves
Indication is to the transcatheter aortic valve replacement (TAVR) market as location is to the real estate business. Although TAVR already represents a $3 billion market globally, the leading TAVR companies say the currently approved indications barely scratches the surface in terms of the true growth potential of the space. This week, just ahead of the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Diego, Medtronic announced that FDA has given the go-ahead for a single-arm study to evaluate the CoreValve Evolut TAVR system in patients with bicuspid aortic valves who are at low risk of s...
Source: MDDI - September 18, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Latest Structural Heart issue features research on TAVR and Mitral VIV and VIR procedures
(Cardiovascular Research Foundation) The Cardiovascular Research Foundation (CRF) is pleased to announce that the latest issue of Structural Heart: The Journal of the Heart Team features original research articles on transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis and left ventricular systolic dysfunction, and the safety and efficacy of percutaneous mitral valve-in-valve and valve-in ring procedures. The full issue is now available online. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 7, 2018 Category: International Medicine & Public Health Source Type: news

A Re-Look at Evaluation of the Severity of Aortic Stenosis A Re-Look at Evaluation of the Severity of Aortic Stenosis
A landmark study with far-reaching implications demonstrates that current methods for evaluating the severity of aortic stenosis may introduce clinically significant error.European Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 4, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Strain May Help in Timing Aortic Stenosis Intervention (CME/CE)
(MedPage Today) -- Registries suggest it reveals early LV dysfunction beyond what LVEF can do (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - August 15, 2018 Category: Cardiology Source Type: news

JenaValve launches feasibility study of next-gen pericardial TAVR system
JenaValve Technology said today it launched an FDA investigational device exemption cleared early feasibility study of its next generation JenaValve pericardial transcatheter aortic valve replacement system. The newly launched trial will explore the use of the device as a minimally invasive treatment for patients with symptomatic, severe aortic stenosis and symptomatic aortic regurgitation in patients who are considered at extreme or high risk for open surgery. “Both myself and my CUMC colleagues, Dr. Susheel Kodali and Dr. Torsten Vahl, are extremely pleased to be the first U.S. physicians to treat patients wit...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves JenaValve Source Type: news

CMS panel votes on volume requirements for TAVR centers
The Center for Medicare and Medicaid Services’ Medicare Evidence Development and Coverage Advisory Committee this week opened itself to comments and voted on volume requirements for new and existing transcatheter aortic valve replacement programs and operators. Panelists heard data from individuals across the healthcare spectrum, and ended up voting in the middle on most of the issues, according to a Medscape report. Voting was done on a one-to-five scale of confidence, with five showing high confidence in the resolution, according to the report. On considering hospitals with no TAVR experience opening new programs, ...
Source: Mass Device - July 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) Source Type: news

Meril Aims for Emerging Markets with its TAVR Device
Yet another company is throwing its hat into the transcatheter aortic valve replacement system (TAVR) market. However, Meril Lifesciences is going a different route than other established firms in the space and is initially targeting emerging markets. Meril has been around for 10 years and has been developing its MyVal TAVR technology for about six of those. The company’s success in TAVR lies around the fact that larger organizations don’t consider emerging markets as the first option. The company said it would seek out approval in India first and eventually make its way to developed markets. “We are posi...
Source: MDDI - July 20, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Aortic Stenosis: Then and Now Aortic Stenosis: Then and Now
Renowned cardiologist Dr. Eugene Braunwald, M.D., highlights the major developments in the assessment and management of severe aortic stenosis during the past half-centuryCirculation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 2, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

CMS Will Reconsider Its Stance on TAVR
Centers for Medicare & Medicaid Services (CMS) took an unprecedented stance in 2012 when it decided to cover transcatheter aortic valve replacement (TAVR) with strict restrictions regarding its use in patients with symptomatic aortic stenosis. One of the key issues regarding that CMS decision is that it included specific procedural volume restrictions, limiting the use of TAVR to high-volume hospitals and medical centers. Some doctors have argued that procedural volume is an outdated metric. To understand just how unprecedented the agency's decision on TAVR was six years ago, we look back at this MD+DI story quoti...
Source: MDDI - June 28, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

JenaValve Keeps Steady Pace in the TAVR Market
JenaValve Technology is making steady progress in the development of its next-generation transcatheter aortic valve replacement (TAVR) system. The Irvine, CA-based company said it has implanted the initial patients in a CE mark study for the treatment of severe aortic regurgitation (AR). The CE mark study is an international, prospective, non-randomized, single-arm trial of the JenaValve Pericardial TAVR System for the treatment of AR in patients who are at increased risk for conventional surgical valve replacement. “Our goal is to enable the treatment of patients with severe aortic regurgitation while avoiding many ...
Source: MDDI - June 21, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

JenaValve launches CE Mark study of next-gen TAVR system
JenaValve Technology said this week it launched a new study of its next-generation pericardial transcatheter aortic valve replacement systems using its Coronatix transfemoral delivery catheter. In the newly launched trial, the Irvine, Calif.-based company will explore the use of the system as a treatment for severe aortic regurgitation in patients who are at high risk for conventional surgical valve replacement. “There is currently no TAVR treatment for severe aortic regurgitation cleared by regulators. These patients do not typically develop calcification at the implant site, so other TAVR valves that rely on t...
Source: Mass Device - June 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves JenaValve Source Type: news

EuroPCR 2018 Roundup: Edwards reportedly pauses Centera valve EU launch
Edwards Lifesciences’ (NYSE:EW) European launch of its Centera valve has been temporarily paused as the company looks to modify the device’s delivery system, according to a Leerink Partner letter to investors highlighting presentations from the EuroPCR 2018 Annual Meeting. Delivery of the unit and its use in clinical cases are slated to resume during the third quarter, according to the letter, with Edwards claiming there will be no impact on its financial guidance for the year. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized deli...
Source: Mass Device - May 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Edwards Lifesciences Source Type: news

MassDevice EuroPCR 2018 Roundup
Valve Tech Roundup – Transcath heart valves getting safer, seeing expanded use   Abbott touts initial data from Portico TAVR study Abbott (NYSE:ABT) today released 30-day data from a study of its Portico transcatheter aortic valve replacement, touting excellent clinical outcomes and low rates of death, disabling stroke and paravalvular leak. The real-world, multicenter, prospective, single-arm Portico I study aimed to explore the safety and efficacy of the Portico valve with independent adjudication of clinical events and independent echocardiography core-lab analysis. Investigators in the study will follo...
Source: Mass Device - May 22, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Edwards Lifesciences Esaote Source Type: news

Treatment with Abbott's Portico ™ Transcatheter Aortic Valve Showed Portico is Safe and Reduces Severe Aortic Stenosis at 30 Days in Real-World Setting
- Data presented at EuroPCR indicated excellent clinical outcomes for Portico in a real-world setting to treat common and life-threatening heart valve disease with minimally invasive option (Source: Abbott.com)
Source: Abbott.com - May 22, 2018 Category: Pharmaceuticals Source Type: news

Detection of the Murmur of Advanced Aortic Stenosis Detection of the Murmur of Advanced Aortic Stenosis
How proficient are physicians at detecting aortic stenosis via ascultation? What role does patient characteristics and clinical context play in their success?Southern Medical Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 26, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news