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 with th...
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, pane...
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 positioned in a ...
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 quoting S...
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 of t...
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 this ...
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 delivery...
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 follow pa...
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
