Cardiovalve Reaches 2 Milestones for its Tricuspid Valve Replacement System
Cardiovalve has a pair of milestones that could help catapult the company into the forefront of the tricuspid valve market. The Or Yehuda, Israel-based company received FDA approval for an early feasibility study of the transcatheter tricuspid valve replacement system and Breakthrough Device Designation for the technology. The study’s primary endpoint is the safety and feasibility of the Cardiovalve technology and procedure in reducing tricuspid regurgitation, with evaluations at 30 days and periodically up to five years. The study will be conducted in collaboration with five leading US hospitals. In a re...
Source: MDDI - February 21, 2020 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Cardiovascular Source Type: news

FDG-PET/CT points to cervical cancer patient outcomes
Several indicators on pretreatment FDG-PET/CT scans can help predict overall...Read more on AuntMinnie.comRelated Reading: Biomarkers on PET, MRI show breast cancer risk FDG-PET/CT within a year of heart valve surgery looks safe FDG-PET/CT helps predict tuberculosis relapse 2 new PET tracers may best FDG in cancer imaging FDG-PET/CT aids in melanoma treatment assessment (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 13, 2020 Category: Radiology Source Type: news

Can 3D printing help optimize cardiac CT protocols?
Patient-specific 3D-printed coronary models have allowed clinicians to determine...Read more on AuntMinnie.comRelated Reading: 3 ways to advance 3D printing in radiology AR, 3D printing make waves in cardiac care 3D printing helps unravel rare cardiac anomalies 3D printing technique improves heart valve sizing 3D printing gives pediatric heart surgery a boost (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 7, 2020 Category: Radiology Source Type: news

Oregon man becomes first to receive minimally invasive heart valve repair
The tricuspid valve, on the right side of the heart between the top and bottom chambers, is very tricky to repair because of its complexity. Until recently, the only option was open-heart surgery. But an Oregon man recently became the first patient in a new clinical trial to have the valve repaired with a minimally invasive procedure. Dennis Eggers, a 73-year-old from Sweet Home, Oregon, said he’s feeling “very well,” about two months after his mid-December valve repair at Oregon Health… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - February 5, 2020 Category: Pharmaceuticals Authors: Elizabeth Hayes 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

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.”...
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.   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 20, 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

Mayo Clinic Q and A: Mitral valve repair with minimally invasive heart surgery
DEAR MAYO CLINIC: Is minimally invasive heart surgery to repair a mitral valve a safer option than open-heart surgery? Is it common for a surgeon to have to switch to an open-heart procedure after starting the surgery? ANSWER: Both minimally invasive heart surgery and traditional surgery that involves opening the chest bone -- a procedure [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - November 29, 2019 Category: Databases & Libraries Source Type: news

Medtech in a Minute: LivaNova Nixes TMVR, FDA Tackles EtO, and More
FDA Wants Medtech to Cut Back on EtO Use FDA is encouraging manufacturers to reduce the amount of paper included in sterile device packaging in order to reduce the amount of ethylene oxide (EtO) required for effective sterilization. A new voluntary master file program also aims to speed up approval of sterilization site relocations and the implementation of methods that reduce the amount of EtO needed to sterilize FDA-approved medical devices.   LivaNova Says Sayonara to TMVR LivaNova is scrapping its Caisson transcatheter mitral valve replacement program because of continued...
Source: MDDI - November 27, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Lower Operating Thresholds for Chronic Severe AR? Lower Operating Thresholds for Chronic Severe AR?
Should current guidelines be revised to include earlier aortic valve surgery for asymptomatic patients with severe aortic regurgitation and a preserved LVEF?Circulation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 26, 2019 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

LivaNova Stops Caisson TMVR Program
LivaNova is scrapping its Caisson transcatheter mitral valve replacement (TMVR) program because of declines its heart valve business has seen over the last five years. Plans now call for the London-based company to enter into a restructuring plan for its heart valve business, which brought in $130 million in revenue in 2018. Under the restructuring plan, it is expected that about 150 employees could be potentially impacted in the three sites of Saluggia, Vancouver, and Minneapolis. LivaNova’s Saluggia, Italy facility will now become dedicated to R&D and production of mechanical heart valves, rings, ac...
Source: MDDI - November 21, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular 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

Cardiac rehab after heart valve surgery tied to better outcomes
(Reuters Health) - Cardiac rehab, known to be helpful after heart attacks, may also aid recovery from heart valve surgery, a study suggests. (Source: Reuters: Health)
Source: Reuters: Health - October 31, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Rate of Surgical Bailout Low for TAVR
THURSDAY, Oct. 31, 2019 -- The need for surgical bailout in patients undergoing transcatheter aortic valve replacement (TAVR) is low, according to a study recently published in JACC: Cardiovascular Interventions. Andres M. Pineda, M.D., from... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 31, 2019 Category: Pharmaceuticals Source Type: news

Boston Sci Gives Update on the Measured Launch of Lotus Edge
Boston Scientific’s Lotus Edge might be one of the biggest and most significant FDA approvals of 2019. However, Boston Scientific has been very measured with launch plans for the transcatheter aortic valve replacement technology. During a recent earnings call, the Marlborough, MA-based company gave an update on the rollout of Lotus Edge to analysts and investors. “The Lotus Edge launch is going extremely well and we’re building momentum in both the U.S. and Europe,” said Michael Mahoney, chairman and CEO of Boston Scientific, according to a Seeking Alp...
Source: MDDI - October 28, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

4 core applications of cardiovascular 3D printing
How are clinicians integrating 3D printing technology into adult cardiovascular...Read more on AuntMinnie.comRelated Reading: 3D-bioprinted model mimics real human heart properties 4D flow MRI, 3D printing improve congenital heart surgery 3D printing technique improves heart valve sizing 3D printing bolsters care for congenital heart disease Flexible 3D-printed heart replicates size, texture (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - October 28, 2019 Category: Radiology Source Type: news

3Q19 Earnings Show Edwards Continues to Have Solid TAVR Story
Edwards Lifesciences made tremendous gains in 3Q19 by toppling consensus forecast and significantly raising revenue. As a result, shares of Edwards jumped by nearly 6%. The Irvine, CA-based company, often called a pioneer in the transcatheter aortic valve replacement (TAVR) market, improved third quarter net sales 20.7% year-over-year to $1.09 billion. Diluted earnings per share for the quarter were $1.30, while adjusted earnings per share grew 32% to $1.41. For 2019, the company now expects total sales around the top of its previous $4 billion to $4.3 billion range. Additionally, the company raised its full-year 2019 adju...
Source: MDDI - October 24, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

AI is a Big Part of Cleveland Clinic ’s 2019 MIS
CLEVELAND – Two words dominated much of the program agenda for Cleveland Clinic’s 2019 Medical Innovation Summit (MIS) on Tuesday – Artificial Intelligence. From a keynote address from Craig Mundie, Senior Advisor to the CEO, and former Chief Research and Strategy Officer, Microsoft to a session discussing companies with non-traditional approaches to healthcare, the topic of AI was discussed. But is AI just the latest fad in healthcare? Is it fully-defined? And are there real-world examples to look to, to see AI in action? Richard Zane, MD CIO of University of Colorado ...
Source: MDDI - October 23, 2019 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news

Tallest man in US breaks down in tears as he reveals that he'll die without heart surgery
Igor Vovkovinskiy, 37, who is 7 feet and 8.33 inches tall, posted a video in which he revealed that he needs heart surgery to fix a valve, but doesn't know if he will survive the operation. (Source: the Mail online | Health)
Source: the Mail online | Health - October 16, 2019 Category: Consumer Health News Source Type: news

Admedus Turns Attention to TAVR Program
Change is in the air for Admedus. The Brisbane, Australia-based company is selling off its CardioCel and VascuCel businesses to LeMaitre Vascular. The deal would give Admedus the space to focus on its transcatheter aortic valve replacement products. Under the agreement terms, Admedus receives $A22.8 million upfront followed by deferred payments of $A1 million each at 12 months and at 36 months. Additionally, the company could receive up to $A11.4 million in earn-out payments. Admedus said it retains manufacturing rights for up to three years and will continue manufacturing CardioCel and VascuCel at its Malaga facility in W...
Source: MDDI - October 15, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Penn Medicine, Mercy Health to establish heart surgery program in Delaware County
Mercy Catholic Medical Center and Penn Medicine are teaming up to establish a cardiovascular surgery program at the Mercy Fitzgerald Campus in Darby. The partnership — preceding by a clinical affiliation between the health care providers forged last year — will include expanding patient access to a wide range of surgical and non-surgical procedures, such as transcatheter aortic valve replacement (TAVR) and robotic cardiac surgery. TAVR is a minimally invasive procedure to treat aortic valve… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - October 14, 2019 Category: Pharmaceuticals Authors: John George Source Type: news

A Blood Filter Fights Deadly Inflammatory Response
A new blood filtration technology may prove to be life-saving for patients whose normally healthy inflammatory response to injury or illness has gone into overdrive, resulting in fatally high levels of cytokines in their blood. In an interview with MD+DI, Dr. Phillip Chan, MD, PhD, CEO of CytoSorbents Corp., explained that inflammation, and the production of substances called cytokines that drive inflammation, are the body’s natural response to heal injury or infection. But sometimes, the inflammatory response is so severe in such conditions as sepsis and infection, burn injuries, trauma, pancreatitis, li...
Source: MDDI - October 9, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Cardiovascular Source Type: news

Tales from TCT 2019: Ancora ’s Heart Felt Data
A stronger and more experienced Ancora Heart entered into the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation this past week. The private company – which is poised to take on medtech giants Abbott Laboratories and Edwards Lifesciences in the functional mitral regurgitation (FMR) space, presented even more data than it did last year at TCT. “There’s a big presence for us this year [at TCT] with three different presentations,” Jeff Closs, president and CEO of Ancora Heart, to...
Source: MDDI - September 30, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

New Data Demonstrate Strong Outcomes for Abbott Device to Repair Leaky Tricuspid Heart Valves
- New data presented at TCT 2019 on Abbott's TriClip device from the TRILUMINATE Feasibility Study met both the primary safety and performance endpoints (Source: Abbott.com)
Source: Abbott.com - September 29, 2019 Category: Pharmaceuticals 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

Abbott ’s Pediatric Cardiovascular Devices Gain CE Mark
Abbott Laboratories is bringing two of its pediatric devices in the cardiology space to Europe. The Abbott Park, IL-based company has received CE mark for both the Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder. The Masters valve is the world's smallest mechanical heart valve and allows doctors to treat babies and toddlers in need of a mitral or aortic heart valve replacement. Until Abbott's device, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, which could result in improper fit and complications. The Masters pediat...
Source: MDDI - September 18, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Abbott Shines Light on “Forgotten Valve” with New Pivotal Trial
Abbott Laboratories’ latest pivotal trial will have the company taking a deeper dive into the treatment of what has been dubbed by some as the “forgotten valve.” The Abbott Park, IL-based has launched an IDE study of the TriClip, a transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR). The TRILUMINATE Pivotal trial will evaluate a catheter-based, non-surgical treatment for patients with severe TR – a condition in which the valve doesn't close properly, allowing blood to flow backward into the heart, which ...
Source: MDDI - September 6, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Abbott Launches World's First Pivotal Trial to Test New Approach for Repairing Leaky Tricuspid Heart Valves
- TRILUMINATE Pivotal trial is the world's first randomized clinical trial to evaluate transcatheter tricuspid valve repair in patients with severe tricuspid regurgitation (Source: Abbott.com)
Source: Abbott.com - September 5, 2019 Category: Pharmaceuticals Source Type: news

Heart Surgery Long-Term Mortality Rate Higher for Women Heart Surgery Long-Term Mortality Rate Higher for Women
Women have worse long-term mortality after coronary-artery bypass grafting (CABG) and combined CABG/mitral-valve surgery, while mortality risk factors are different for men and women, according to new findings.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - September 3, 2019 Category: Surgery Tags: General Surgery News Source Type: news

Fully Retrievable Valve Shows Promise for TAVR Fully Retrievable Valve Shows Promise for TAVR
The fully retrievable HLT Meridian valve appears safe and effective for transcatheter aortic-valve replacement (TAVR), according to results from the multicenter RADIANT trial.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 23, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news

Burst Balloons Prompt Edwards to Recall Sapien 3 Ultra Delivery System
Reports of balloons bursting during transcatheter aortic valve replacement (TAVR) implantation procedures prompted Edwards Lifesciences to recall 1,585 Sapien 3 Ultra delivery systems from the U.S. market. The company initiated the recall in July but FDA just issued the associated safety alert on Thursday. The incidents of burst balloons during implantation procedures have resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, which may cause vascular injury, bleeding, or the need for surgical intervention. The issue has resulted in 17 injuries and one death, ...
Source: MDDI - August 22, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Burst Balloons Prompt Edwards to Add Warning to Sapien 3 Ultra Delivery Instructions
Reports of balloons bursting during transcatheter aortic valve replacement (TAVR) implantation procedures prompted Edwards Lifesciences to issue a field safety notice in July with instructions for physicians who treat patients with the Sapien 3 Ultra valve. FDA issued this safety alert on Aug. 22 calling the action a recall. However, an Edwards spokesperson told MD+DI that the device is not actually being pulled from the market and no devices are being returned as part of this action. The reported incidents of burst balloons during implantation procedures have resulted in significant dif...
Source: MDDI - August 22, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

FDA Slaps Class I Recall on Sapien 3 Ultra for TAVR FDA Slaps Class I Recall on Sapien 3 Ultra for TAVR
The class I recall of the transcatheter aortic valve replacement (TAVR) device follows an urgent field warning about burst balloons issued last month by device maker, Edwards Lifesciences.News Alerts (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - August 22, 2019 Category: Cardiology Tags: Cardiology News Alert 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

Today, FDA became the first medical products regulatory body in the world to approve an expanded indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery: https://go.usa.gov/xVCnx   pic.twitter.com/i4Y0jh52Xh
Today, FDA became the first medical products regulatory body in the world to approve an expanded indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery: https://go.usa.gov/xVCnx  pic.twitter.com/i4Y0jh52Xh (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 16, 2019 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

Your Medtech Download List
We've put together a list of the latest how-to medtech whitepapers and Webcasts available from Qmed. You’ll find expertise on catheter technologies for TAVR procedures, EU Medical Device Regulations, biomaterials, electroplating, and more. We also share news on upcoming educational offerings at upcoming MD&M and BIOMEDevice events. If you’re looking for education on a topic you don’t see, please feel free to let us know at daphne.allen@ubm.com. We welcome suggestions from our medtech community. Whitepapers Repairing the Heart With...
Source: MDDI - August 7, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Materials 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