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

Are the Odds Ever in Edwards & #039; Favor in the TAVR Games?
With competition picking up in the transcatheter aortic valve replacement (TAVR) space, it's easy to wonder if Edwards Lifesciences will continue to be the market victor. The company's stock price dipped this week after Edwards posted first-quarter results that fell short of consensus expectations. But to borrow a popular phrase from Suzanne Collins' Hunger Games trilogy, there is still plenty of reason to believe that the odds may be ever in Edwards' favor. Here are the key takeaways from the company's earnings call, as transcribed by Seeking Alpha, along with analyst comments. 1. Medtronic's royalty payment rat...
Source: MDDI - April 25, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Rapid Deployment Valve for Aortic Stenosis Ups Stroke Risk
FRIDAY, April 13, 2018 -- For patients with aortic valve stenosis, treatment with a rapid deployment valve (RDV) is associated with increased rates of new-onset pacemaker implantation and disabling stroke, compared with conventional biological... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 13, 2018 Category: Pharmaceuticals Source Type: news

JenaValve Is a Growing Force to be Reckoned with in TAVR
It would be a big mistake to leave JenaValve out of the transcatheter aortic valve replacement (TAVR) market conversation. The Munich, Germany-based company has been biding its time and reaching milestones, in the hopes of obtaining some serious market share in the TAVR space. The small company's latest achievement is successfull enrollment in the CE mark study of the next generation of JenaValve Pericardial TAVR system. “It’s very tricky to develop a TAVR system because it can take several iterations before you can get it right,” Victoria Carr-Brendel, JenaValve CEO, told MD+DI. “We think we ...
Source: MDDI - April 11, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

NOTION: 5-Year TAVR vs SAVR Outcomes Similar in Low-Risk Patients NOTION: 5-Year TAVR vs SAVR Outcomes Similar in Low-Risk Patients
All-cause mortality, MI, and stroke were similar in low-risk patients with severe aortic stenosis who had transcatheter aortic valve replacement and those who had surgery, but 42% of TAVR patients needed pacemakers.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 9, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Edwards Eyes Delay for its Sapien 3 Ultra TAVR
Edwards Lifesciences said it is delaying the launch of the Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) System in Europe until later this year. The Irvine, CA-based company said it would refocus on commercialization efforts after it submits data from the 30-patient, single-arm study of the device treating patients at intermediate risk from surgical valve replacement. The study data would help supplement the company’s bid to gain CE mark for the technology. Edwards said the updated timing for the European launch of the Sapien 3 Ultra doesn’t change the company’s sales guidance for 2018...
Source: MDDI - March 22, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Source Type: news

Colibri Course Corrects to be Relevant in TAVR
Colibri Heart Valve LLC has started a feasibility study of its second-generation transcatheter aortic valve replacement system that will treat patients with severe aortic stenosis. The Broomfield, CO-based company said it has treated two patients in the study with its redesigned valve. “We spent the last three years modifying our product because the market has changed so drastically from 2012, in both patient indications and also bicuspid valves,” Joseph Horn, president and CEO of Colibri Heart Valve, told MD+DI. “We decided that the product we had was probably not going to be robust enough to satisfy the...
Source: MDDI - March 19, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Implants Source Type: news

TAVR Reasonable for Low-Flow, Low-Gradient Aortic Stenosis (CME/CE)
(MedPage Today) -- Low 30-day mortality observed in high-risk group (Source: MedPage Today Surgery)
Source: MedPage Today Surgery - March 19, 2018 Category: Surgery Source Type: news

Medtronic and Edwards Duel in TAVR Space
A pair of studies support the long-term use of Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system. The Dublin-based company unveiled results from both the Nordic Aortic Valve Intervention Trial (NOTION) and the CoreValve U.S. Pivotal Extreme Risk Study at the American College of Cardiology 67th Annual Scientific Session (ACC) this past weekend. NOTION is a physician-initiated trial that studied an all-comers population of 280 patients at least 70 years old. Patients in the trial were randomized to either Surgical Aortic Valve Replacement (SAVR) or TAVR procedures. Join us at the BIOM...
Source: MDDI - March 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Edwards Adds Bold New Chapter to TAVR Story
Edwards Lifesciences just might have leaped-frogged over some of its competitors in the burgeoning  TAVR market. The undisputed TAVR pioneer has received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards Centera valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. The company said the device is packaged with the valve fully pre-attached to the delivery system, which helps with simple and rapid device preparation. Network with your colleagues in medtech at ADM&...
Source: MDDI - February 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Medical Device Business Source Type: news

Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. 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 Irvine, Calif.-based company said. “With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-ex...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

The Future of TAVI The Future of TAVI
While TAVI has emerged as the established therapy for patients with severe, symptomatic aortic stenosis, there are still challenges that remain, and improvements that can be made.European Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 25, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Cardiac Amyloid Buildup Not Uncommon In TAVR Patients
(MedPage Today) -- Study opens question of interaction between aortic stenosis, amyloid (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - January 22, 2018 Category: Cardiology Source Type: news

Ashfield are shortlisted for a PM Award
Ashfield Digital & Creative, alongside our colleagues at Watermeadow Medical and our clients at Edwards Lifesciences, are thrilled to announce that we have been shortlisted for a PM Society Award in the Primary Care Campaign category for ‘Listen to the Heart’. A campaign focused on the lifesaving opportunity available to GPs through the early identification of aortic stenosis. Speaking about the collaboration, which led to this campaign, Ashfield Digital & Creative Senior Vice-President Andrew Binns said, “This entry demonstrates the impact that can be achieved when strategic insights and cre...
Source: Ashfield Healthcare News - January 18, 2018 Category: Pharmaceuticals Authors: Daniel Goodwin Tags: Ashfield Source Type: news

Edwards Lifesciences recalls Certitude delivery device for Sapien 3 valve
Edwards Lifesciences (NYSE:EW) is recalling the Certitude delivery device used with its Sapien 3 replacement heart valve on the risk that a molding defect could embolize, the FDA said today. The Sapien 3 is a transcatheter aortic valve replacement designed to treat aortic stenosis. During implantation the valve is crimped to Certitude’s balloon before either transapical or transaortic insertion into the body. The recall, of some lots made between Nov. 22, 2016, and July 10 of last year, is due to a molding overflow defect in the button valve within Certitude’s loader, according to the federal safety watchd...
Source: Mass Device - January 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Recalls Replacement Heart Valves Edwards Lifesciences Source Type: news

3 Reasons TAVR Will Continue to Prosper
The transcatheter aortic valve replacement (TAVR) market has already seen rapid growth, and today represents a $3 billion market globally. But the leading TAVR companies say the current technology and approved indications barely scratches the surface in terms of the true growth potential of the space. Michael Mussallem, CEO of Edwards Lifesciences, told J.P. Morgan Healthcare Conference attendees on Monday that the global TAVR market is expected to exceed $5 billion by 2021, and that number does not include certain indications that are currently being explored, like treatment for patients with asymptomatic aortic...
Source: MDDI - January 9, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Impaired Survival With LVEF < 60 Percent in Aortic Stenosis
Poorer outcomes seen for LVEF (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - January 5, 2018 Category: Respiratory Medicine Tags: Cardiology, Nursing, Pathology, Pulmonology, Critical Care, Journal, Source Type: news

' Normal' LVEF: Misnomer in Aortic Stenosis?
(MedPage Today) -- Study shows survival in severe aortic stenosis impaired with LVEF (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - December 27, 2017 Category: Cardiology Source Type: news

Can Boston Scientific Bounce Back from Lotus Setback?
Boston Scientific shares took a beating Tuesday after the company abruptly backed out of a scheduled appearance at the annual Piper Jaffray healthcare conference in New York. As investors seemed to fear, the sudden change of plans foreshadowed another Lotus setback. The company's stock (NYSE: BSX) dropped 7.5% by market close on Tuesday, slashing Boston Scientific's market cap by about $2.9 billion. About three hours after the close, the company said it had pushed back its previously-reported timelines for re-introducing the Lotus Edge aortic valve system in Europe, and the filing of a final pre-market approval (PMA) modul...
Source: MDDI - November 29, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Cardiovascular Source Type: news

Boston Scientific takes a $3B hit on latest Lotus valve delay
Boston Scientific (NYSE:BSX) saw its market capitalization lose $3 billion after yesterday revealing another delay for its Lotus replacement heart valve. The Marlborough, Mass.-based company, which recalled the Lotus transcatheter aortic heart valve in February over issues with its locking mechanism, said it no longer expects the ensuing manufacturing and design specification changes to get the valve back on the market in Europe or allow the final filing in its pre-market approval bid with the FDA by January 2018. “We continue to see value in the unique benefits of the LOTUS Valve platform in treating patients w...
Source: Mass Device - November 29, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Replacement Heart Valves Wall Street Beat Boston Scientific Source Type: news