Abbott Wins Approval for CATALYST Trial for At-Risk Stroke Patients
This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with AFib who are at an increased risk for ischemic stroke."
In an email sent to MD+DI, Abbott wrote, “We already have an Amulet IDE trial underway that is intended to support our submission for approval in the U.S. for Amplatzer Amulet. The newly announced CATALYST trial will support our submission for an expanded indication for Amulet as a safe and effective alternative to NOAC drugs for patients with atrial fibrillation and at risk of stroke.â€
Abbo...
Source: MDDI - February 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news
TAVR Valves Compared, and Other Lessons on the Management of AS TAVR Valves Compared, and Other Lessons on the Management of AS
Walid Amara and Eric Van Belle discuss the latest data from the American Heart Association meeting on transcatheter aortic valve replacement and AS management.theheart.org on Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - February 3, 2020 Category: Cardiology Tags: Cardiology Expert Interview Source Type: news
Abbott Has Big Win in TMVI Market
The transcatheter mitral valve implantation (TMVI) market is receiving a huge jolt through a new regulatory approval. Abbott Laboratories said it has obtained CE mark for the Tendyne System.
The Abbott Park, IL-based company’s device treats significant mitral regurgitation in patients requiring heart valve replacement who are not candidates for open-heart surgery or transcatheter mitral valve repair.
Tendyne is delivered through a small incision in the chest and up through the heart where it is implanted in a beating heart, replacing the person's native mitral valve. Abbott’s valve is fu...
Source: MDDI - January 30, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
Abbott's Tendyne(TM) Device Receives World's First CE Mark for Transcatheter Mitral Valve Implantation
First-of-its-kind technology addresses critical need to eliminate mitral regurgitation when surgery or mitral repair is not an option
Tendyne valve provides relief from heart failure symptoms and quality-of-life improvement in high-surgical-risk patient... Devices, Interventional, Cardiology, Regulatory Abbott, Tendyne, Transcatheter, Mitral Valve, TMVI (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 30, 2020 Category: Pharmaceuticals Source Type: news
NEJM: transcatheter aortic valve replacement shows similar safety outcomes as open-heart surgery
(Cedars-Sinai Medical Center) A new study from the Smidt Heart Institute at Cedars-Sinai and other centers nationwide shows that patients who underwent a minimally invasive transcatheter aortic-valve replacement (TAVR), had similar key 5-year clinical outcomes of death and stroke as patients who had traditional open-heart surgery to replace the valve. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 29, 2020 Category: International Medicine & Public Health Source Type: news
TAVR Increasingly Being Used in Young Adults Despite Uncertainty
TUESDAY, Jan. 28, 2020 -- For young adults undergoing aortic valve replacement (AVR), use of transcatheter AVR (TAVR) has increased even though open heart surgery currently is considered the best option, according to a study presented at the annual... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 28, 2020 Category: Pharmaceuticals Source Type: news
Should We Worry About Bicuspid Aortic Valve?
Discussion
The aortic valve usually has 3 leaflets. In bicuspid aortic valve (BAV) there are 2 asymmetric leaflets with a fish-mouthed orifice between them which may not open fully. It occurs in about 0.5-2% of the population making it one of the most common congenital heart anomalies and the most common one in adults. Transmission is autosomal dominant yet males are more likely to have BAV, indicating potential reduced penetrance in females. “BAVs are different, however, in that the tissue pathology is not limited to the valves’ leaflets but extends from the left ventricular outflow tract to the ascending thor...
Source: PediatricEducation.org - January 27, 2020 Category: Pediatrics Authors: Pediatric Education Tags: Uncategorized Source Type: news
ECG Challenge: Cardiac Abnormalities After Aortic Valve Replacement ECG Challenge: Cardiac Abnormalities After Aortic Valve Replacement
At a routine follow-up after an aortic valve replacement, a 56-year-old woman complains of fatigue and chest discomfort. What does her ECG show?Medscape Cardiology (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - January 21, 2020 Category: Intensive Care Tags: Cardiology Clinical Case Source Type: news
FDA clears patient-specific 3D-printed airway stent
The U.S. Food and Drug Administration (FDA) has cleared patient-specific 3D-printed...Read more on AuntMinnie.comRelated Reading:
3 ways to advance 3D printing in radiology
3D printing helps unravel rare cardiac anomalies
3D printing may improve safety of upper GI surgery
Wash. groups partner on 3D printing for heart disease
3D printing technique improves heart valve sizing (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 13, 2020 Category: Radiology Source Type: news
Medtech in a Minute: A Huge Merger Flop, a TAVR Breakthrough, and More
Illumina-PacBio Merger Axed
Illumina and PacBio called off a $1.2 billion merger after FTC ran interference, saying the pairing could create a monopoly in the next-generation sequencing market. Illumina will now pay PacBio a termination fee of $98 million.
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Breakthrough Device Designation Signals a Promising Year for TAVR
FDA granted JenaValve a breakthrough device designation for pericardial transcatheter aortic valve replacement (TAVR) system, signaling another promising year for the space. The designation is for severe aortic regurgitation (AR) and AR-dominant mixed aorti...
Source: MDDI - January 10, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Does JenaValve ’s New Designation Signal the Start of Another Strong Year for TAVR?
JenaValve is showing significant progress in the plan to get its transcatheter aortic valve replacement (TAVR) system approved. FDA granted the Irvine, CA-based company Breakthrough Device Designation for the JenaValve Pericardial TAVR system.
This designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease, a life-threatening and seriously debilitating condition, in patients at high risk for surgery. The JenaValve Pericardial TAVR System consists of a bioprosthesis comprised of a self-expanding nitinol stent with a porcine pericardial valve manufactured using state-of-the-art tissue proc...
Source: MDDI - January 9, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news
20 Private Companies to Watch in 2020
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us.
So without further ado, here are the 20 companies that made the cut:
4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - December 24, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
20 Private Medtech Companies to Watch in 2020
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us.
So without further ado, here are the 20 companies that made the cut:
4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - December 24, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Change Proposed to Streamline Hospital TAVR Quality Metrics Change Proposed to Streamline Hospital TAVR Quality Metrics
What if performance assessments for transcatheter aortic-valve replacement centered on one number rather than two, especially considering the resources hospitals must dedicate to tracking outcomes?Medscape Medical News (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - December 19, 2019 Category: Surgery Tags: Cardiology News Source Type: news
What Does 2020 Have in Store for Medtech?
It's the time of year for reflection and prognostication. A recent report from Mike Matson, a medtech analyst at Needham & Co., offers a little of both for the medical device industry.
Here are the key takeaways from Matson's Dec. 19 report:
Matson said he expects medtech market growth to improve somewhat in the new year (from 4.9% in 2019 to 5.5% in 2020 on a constant currency basis). Breaking that down to specific sectors, the analyst expects to see market growth in knee and hip replacements, spine, trauma, extremities, cardiovascular, pacemakers, peripheral vascular, transcatheter aortic valve replacement, drug-elut...
Source: MDDI - December 19, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
