Best Practices for Human-Centric Design of Medical Devices
Medical devices designed to accommodate human variability present a growing opportunity for the healthcare and life sciences industries. Historically, medicine has solved many of the “simple” issues first: how to fix a broken leg has been known for centuries! But today we have treatments that didn’t even exist a generation ago, such as the use of stents and replacement valves for heart disease. These devices address a more limited cohort of people and are most successful when designed to be patient-specific. The cohorts themselves must also be further defined to account...
Source: MDDI - May 5, 2020 Category: Medical Devices Authors: Kristian Debus Tags: Design Source Type: news

CT helps predict TAVR outcomes
Identifying fibrotic lung disease on CT before transcathetor aortic valve replacement...Read more on AuntMinnie.comRelated Reading: 4D CT sheds light on post-TAVR treatment strategies 3D printing technique improves heart valve sizing 3D-printed aortas could work well for TAVR 3D printing helps evaluate leaks after TAVR procedures CT better than echo for aortic annulus before TAVR (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - May 4, 2020 Category: Radiology Source Type: news

Edwards Lifesciences Drops 2020 Revenue Guidance Due to COVID-19
While Edwards Lifesciences reported first-quarter sales growth of 14%, the structural heart company saw a steep drop in procedure volume in the last few weeks of the quarter due to COVID-19. "As you might expect, procedure volumes in March varied greatly by geography, even by hospital, as patients and providers turned their focus to the pandemic," CEO Mike Mussallem said during the company's first-quarter earnings call, according to a SeekingAlpha transcript. Mussallem said the company expects the impact of COVID-19 on its transcatheter aortic valve replacement (TAVR) sales to be most severe in the second quarter...
Source: MDDI - April 25, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news

With a heavy heart: How men and women develop heart disease differently
(McGill University) A new study by researchers from McGill University has uncovered that minerals causing aortic heart valve blockage in men and women are different, a discovery that could change how heart disease is diagnosed and treated. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 24, 2020 Category: International Medicine & Public Health Source Type: news

Pi-Cardia Closes a $27 Million Financing led by Sofinnova Partners to Continue Clinical Trials With Its Leaflex(TM) Aortic Valve Technology
REHOVOT, Israel, April 20, 2020 -- (Healthcare Sales & Marketing Network) -- Pi-Cardia Ltd., a global leader in the development of non-implant catheter-based solutions for treating heart valve calcification, announced today it has closed a $27 million rou... Devices, Interventional, Cardiology, Venture Capital Pi-Cardia, Leaflex Performer, Leaflex, heart valve calcification (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 20, 2020 Category: Pharmaceuticals Source Type: news

Catheter-Based Solution Being Developed to Treat Heart Valve Calcification
Pi-Cardia Ltd. has raised $27 million to develop a catheter-based solution to treat heart valve calcification. The Rehovot, Israel-based company said the financing was led by Sonfinnova Partners and joined by Professor Jacques Séguin, Chairman of the company, with further participation from existing investors. The financing follows the successful completion of the company’s First-In-Human studies of the Leaflex Catheter. Pi-Cardia said its technology performs mechanical scoring of valve calcification, restoring leafelts’ mobility and improving valve hemodynamics. The company...
Source: MDDI - April 20, 2020 Category: Medical Devices Authors: MDDI Staff Tags: Business Cardiovascular Source Type: news

PET/CT pinpoints Hodgkin's lymphoma treatment response
PET/CT significantly outperformed CT alone in predicting treatment response...Read more on AuntMinnie.comRelated Reading: FDG-PET leads prediction on neuroendocrine tumor outcomes IMV: PET scan volume continues growing at steady pace FDG-PET/CT points to cervical cancer patient outcomes FDG-PET/CT within a year of heart valve surgery looks safe PET/CT beats SPECT for neuroendocrine tumors (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 20, 2020 Category: Radiology Source Type: news

TAVR equivalent to surgery at 2 years among low-risk patients
(American College of Cardiology) Patients undergoing transcatheter aortic valve replacement (TAVR) fared equally well compared with those undergoing open heart valve replacement surgery in terms of the combined risk of death, stroke or rehospitalization at two years, the primary endpoint of the PARTNER 3 trial being presented at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC). (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 30, 2020 Category: International Medicine & Public Health Source Type: news

TAVR found non-inferior to surgery in broad patient population
(American College of Cardiology) Patients who underwent transcatheter aortic valve replacement (TAVR) did not have a higher rate of death at one year compared with those who had their heart valve replaced via open-heart surgery, according to research presented at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC). (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 30, 2020 Category: International Medicine & Public Health Source Type: news

Landmark Phase 3 VOYAGER PAD Study of XARELTO ® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization
RARITAN, NJ, March 28, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular (CV) events by 15 percent in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, with similar rates of TIMI[1] major bleeding. VOYAGER PAD is the only study to show a significant benefi...
Source: Johnson and Johnson - March 28, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Highlights Continued Commitment to Cardiovascular & Metabolic Healthcare Solutions with Late-Breaking Data at the First Fully Virtual American College of Cardiology Scientific Session
RARITAN, N.J., March 20, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the virtual American College of Cardiology’s 69th Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC) on March 28-30, 2020. Notably, four late-breaking abstracts for XARELTO® (rivaroxaban) will be presented, including data from the Phase 3 VOYAGER PAD study in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization.Click to...
Source: Johnson and Johnson - March 20, 2020 Category: Pharmaceuticals Source Type: news

TAVR Device Orientation May Reduce Coronary Overlap TAVR Device Orientation May Reduce Coronary Overlap
Initial orientation of transcatheter heart valves may potentially preserve coronary access, a study suggests.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - March 18, 2020 Category: Cardiology Tags: Cardiology News Source Type: news

3D printing improves accuracy of knee arthroplasty
A new technique that relies on 3D-printed surgical guides designed with CT...Read more on AuntMinnie.comRelated Reading: Can ultrasound, 3D printing deepen maternal-fetal bonds? Can 3D printing help optimize cardiac CT protocols? 3D printing may improve safety of upper GI surgery 3D-printed head customizes neurosurgery simulation 3D printing technique improves heart valve sizing (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 3, 2020 Category: Radiology Source Type: news

AHA News: When an Untreated Infection Leads to Heart Valve Disease
Title: AHA News: When an Untreated Infection Leads to Heart Valve DiseaseCategory: Health NewsCreated: 2/24/2020 12:00:00 AMLast Editorial Review: 2/25/2020 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - February 25, 2020 Category: Cardiology Source Type: news

AHA News: When an Untreated Infection Leads to Heart Valve Disease
MONDAY, Feb. 24, 2020 (American Heart Association News) -- Much as he tried, Gabriel Oluka could never keep up with other children. As he got older, he experienced heaviness in his chest, frequent sore throats and occasional painful joints.... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 24, 2020 Category: General Medicine Source Type: news

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

Pioneering heart valve that grows inside the body could transform lives of children with defects
The prosthetic created by Boston Children's Hospital has been hailed as a huge step forward in medical care. In young lambs, it expanded with the growth of their own hearts. (Source: the Mail online | Health)
Source: the Mail online | Health - February 20, 2020 Category: Consumer Health News Source Type: news

Artificial Heart Valve Would Grow With Kids, Cutting Need for Repeat Surgeries
Title: Artificial Heart Valve Would Grow With Kids, Cutting Need for Repeat SurgeriesCategory: Health NewsCreated: 2/19/2020 12:00:00 AMLast Editorial Review: 2/20/2020 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - February 20, 2020 Category: Cardiology Source Type: news

Artificial Heart Valve Would Grow With Kids, Cutting Need for Repeat Surgeries
WEDNESDAY, Feb. 19, 2020 -- An expandable artificial heart valve could save children with congenital heart disease from repeated open heart surgeries as they grow up, researchers report. Current artificial heart valves are fixed in size, meaning... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 19, 2020 Category: General Medicine 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

Aikawa, Shin Win Department of Medicine 2020 Innovation Evergreen Fund Award
Elena Aikawa, MD, PhD, director of the Heart Valve Translational Research Program in the Division of Cardiovascular Medicine, and Su Ryon Shin, PhD, of the Division of Engineering in Medicine, received the Brigham Department of Medicine ’s 2020 Innova (Source: BWH News)
Source: BWH News - February 7, 2020 Category: Hospital Management 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

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

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

WPI researcher to probe link between cell death, calcification, and heart valve disease
(Worcester Polytechnic Institute) Worcester Polytechnic Institute researcher Kristen Billiar has been awarded a $154,000 grant from the American Heart Association to determine how cell death leads to calcium deposits that cause aortic valves to fail. The two-year project will involve laboratory experiments with cells grown in flat and three-dimensional shapes, and it will aim to discover ways to interrupt the process that leads to calcified nodules. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 30, 2020 Category: International Medicine & Public Health 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

Venus Medtech Announces the Addition of Two Cardiovascular Experts to Their Advisory Team
HANGZHOU, China, Jan. 20, 2020 -- (Healthcare Sales & Marketing Network) -- The leading transcatheter heart valve medical device player in China - Venus Medtech (Hangzhou) Inc. ("Venus Medtech" or the "Company", stock code: 2500.HK), t... Devices, Interventional, Cardiology, Personnel Venus Medtech, transcatheter heart valve, VenusA-Valve (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 20, 2020 Category: Pharmaceuticals 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

Reducing the risk of blood clots in artificial heart valves
(University of Bern) People with mechanical heart valves need blood thinners on a daily basis, because they have a higher risk of blood clots and stroke. Researchers at the ARTORG Center of the University of Bern, Switzerland, now identified the root cause of blood turbulence leading to clotting. Design optimization could greatly reduce the risk of clotting and enable these patients to live without life-long medication. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 13, 2020 Category: International Medicine & Public Health 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

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

Early Menopause Increases Heart Risks
Menopause before age 40 increased the risk for coronary artery disease, heart failure, blood clots and heart valve problems. (Source: NYT Health)
Source: NYT Health - November 21, 2019 Category: Consumer Health News Authors: Nicholas Bakalar Tags: Menopause Heart Source Type: news

Edwards SAPIEN 3 TAVI Receives Expanded Approval In Europe
Superior TAVI Valve Indicated for All Patients Diagnosed with Aortic Stenosis IRVINE, Calif., Nov. 6, 2019 -- (Healthcare Sales & Marketing Network) -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for st... Devices, Interventional, Cardiology, Regulatory Edwards Lifesciences, SAPIEN 3, transcatheter, heart valve, aortic valve (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 6, 2019 Category: Pharmaceuticals 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

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

Community Health Workers Are Vital; Governments Should Be Paying Them
Illness is universal, health care is not. Over half of the world’s 7.3 billion people, including 1 billion in rural communities, lack access to health care. Approximately 13 million children still go without a single dose of any vaccine. Nearly 9 million newborns, children and mothers still die each year from preventable or treatable conditions. Compounding this crisis is a massive health-worker shortage, forecast to grow to 18 million by 2030. Training more doctors is necessary, but because doctors are concentrated in cities, they alone are insufficient to close this gap. What if the residents of rural communities&n...
Source: TIME: Health - October 24, 2019 Category: Consumer Health News Authors: Dr. Raj Panjabi Tags: Uncategorized Healthcare 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

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

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 Announces European Approval of Two Life-saving Heart Devices for Babies and Children
World's smallest pediatric treatments pioneered by Abbott address critical needs for the most vulnerable patients: babies and children born with common congenital heart defects Includes pediatric mechanical heart valve and first minimally invasive devic... Devices, Cardiology, Regulatory Abbott, Masters HP, Amplatzer Piccolo, patent ductus arteriosus (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 17, 2019 Category: Pharmaceuticals Source Type: news

Antibiotics Tied to Heart Valve Problems
The class of antibiotics called fluoroquinolones (Cipro, Levaquin and others) may increase the risk of heart valve problems. (Source: NYT Health)
Source: NYT Health - September 17, 2019 Category: Consumer Health News Authors: Nicholas Bakalar Tags: Antibiotics Heart Levaquin (Drug) 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

Wash. groups partner on 3D printing for heart disease
Researchers in Washington are collaborating on the use of 3D printing to facilitate...Read more on AuntMinnie.comRelated Reading: 3D-bioprinted model reproduces heart structure, function 3D-bioprinted model mimics real human heart properties 3D printing technique improves heart valve sizing 3D-printed aortas could work well for TAVR Flexible 3D-printed heart replicates size, texture (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - August 23, 2019 Category: Radiology 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

Edwards Lifesciences, Medtronic heart valves win FDA approval for expanded use
Heart valve systems from Edwards Lifesciences Corp and Medtronic Plc have been approved for use in a condition that restricts blood flow from the heart in patients at low-risk of death linked to open-heart surgeries, the FDA said on Friday. (Source: Reuters: Health)
Source: Reuters: Health - August 16, 2019 Category: Consumer Health News Tags: healthNews 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

Ky. hospital offers customized 3D-printed hearts for $5
Researchers from Kentucky are producing individually tailored 3D-printed heart...Read more on AuntMinnie.comRelated Reading: Study affirms accuracy of 3D-printed anatomical models AR, 3D printing enhance planning for complex heart surgery 3D-bioprinted model mimics real human heart properties 3D printing technique improves heart valve sizing 3D-printed aortas could work well for TAVR (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - July 29, 2019 Category: Radiology Source Type: news

Every Heartbeat Matters Initiative Could Impact 1.5 Million Underserved People by 2020
Although Edwards Lifesciences has long considered philanthropy to be an important part of its company philosophy, several years ago the company began to consider taking a more proactive stance in its giving. “We began to think about how we can bring the time and the talent of our employees, and our connections to having a meaningful impact on an issue, and positively influence and inspire others to join us,” said Amanda C. Fowler, executive director, global corporate giving, Edwards Lifesciences and Edwards Lifesciences Foundation, in an interview with MD+DI. Her team and the...
Source: MDDI - July 16, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Cardiovascular Source Type: news