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Cardiovascular
Medtronic's Evolut TAVR Outperforms Edwards' Sapien in Head-to-Head Trial
Medtronic's SMART trial is also the largest TAVR trial to date to enroll primarily women (87%).
Sam Brusco, Associate Editor
04.08.24
Cardiovascular
Edwards' EVOQUE Wins FDA Nod for Tricuspid Valve Replacement
The EVOQUE valve replacement system is the first transcatheter therapy to earn FDA approval for the tricuspid valve.
Sam Brusco, Associate Editor
02.02.24
Edwards to Spin Off Critical Care Biz in 2024
Edwards said spinning off the business will help sharpen its focus on transcatheter/surgical therapies and make new investments.
Sam Brusco, Associate Editor
12.07.23
Cardiovascular
5-Year Data Backs Edwards' Sapien 3 TAVR
Data from the PARTNER 3 trial showed rates of all-cause mortality, disabling stroke, and rehospitalization remained low.
Sam Brusco, Associate Editor
10.26.23
Cardiovascular
Edwards' Mitris Resilia Mitral Valve Gains EU Nod
COMMENCE aortic trial data on Resilia tissue showed 99.3% freedom from structural valve deterioration.
Sam Brusco, Associate Editor
10.26.23
Cardiovascular
Edwards' EVOQUE Transcatheter Tricuspid Valve Earns EU Nod
The company says it’s the first transcatheter valve replacement therapy to earn regulatory approval to treat tricuspid regurgitation.
Sam Brusco, Associate Editor
10.19.23
Edwards Lifesciences
...
07.20.23
Illumina Taps Hologic, Edwards Execs for Board
Steve MacMillan, chairman, president, and CEO of Hologic and Scott Ullem, corporate VP and CFO of Edwards, joined the board.
Sam Brusco, Associate Editor
06.06.23
Cardiovascular
|
Surgical
Edwards Releases 7-Year Resilia Aortic Valve Data
COMMENCE aortic trial data showed 99.3% freedom from structural valve deterioration.
Sam Brusco, Associate Editor
05.08.23
Edwards Lifesciences CEO Michael Mussallem to Retire in 2023
TMTT corporate VP and GM Bernard Zovighian will succeed Mussallem as CEO in May.
Sam Brusco, Associate Editor
12.08.22
Cardiovascular
|
Surgical
Edwards Shares 1-Year Data on EVOQUE Transcatheter Tricuspid Valve Replacement
Largest dataset among transcatheter tricuspid valve replacement therapies.
11.29.22
Cardiovascular
Edwards' Pascal Precision OK'ed for Mitral Valve Repair
Transcatheter valve repair system FDA approved for transcatheter edge-to-edge repair.
Sam Brusco, Associate Editor
09.15.22
Cardiovascular
Edwards Releases Sapien 3 Ultra Resilia Heart Valve
The company rolled out the next-gen TAVR device after a recent FDA approval.
Sam Brusco, Associate Editor
09.12.22
Cardiovascular
|
Surgical
Edwards' PASCAL Precision Gains EU Nod
System earned a CE mark for transcatheter mitral and tricuspid valve repair.
Sam Brusco, Associate Editor
08.18.22
Edwards Lifesciences
...
07.20.22
Cardiovascular
|
Surgical
FDA Approves Edwards' Mitris Resilia Surgical Mitral Valve
Mimics the asymmetric shape of the native mitral valve.
Sam Brusco, Associate Editor
03.31.22
Cardiovascular
|
Surgical
Edwards' Sapien 3 with Alterra OK'ed for TPV Replacement
Combines Sapien 3 transcatheter heart valve and the Alterra adaptive prestent.
PR Newswire
12.20.21
Cardiovascular
|
Patient Monitoring
|
Surgical
Edwards Presents 2022 Growth and Tech Strategies
Long-term growth strategy and technology pipeline updates were discussed.
Sam Brusco, Associate Editor
12.09.21
Aziyo Biologics Appoints Peter G. Edwards as General Counsel
New hire nearly 30 years of experience in domestic and global public companies, including significant general counsel roles.
Globe Newswire
12.02.21
Cardiovascular
|
Surgical
Edwards Touts 6-Month Transcatheter Tricuspid Replacement Data
Favorable patient outcomes were sustained at six months.
PR Newswire
11.08.21
Edwards Lifesciences
...
07.22.21
Keith Edwards Appointed CEO of N2 Biomedical
Most recently served as SVP and general manager of Hamilton Thorne, Ltd.
PR Newswire
06.30.21
Cardiovascular
|
Patient Monitoring
FDA OKs Edwards' Acumen IQ Cuff Hypotension Prediction Index Software
Uses machine learning to alert clinicians of likelihood a patient is trending toward hypotension.
Sam Brusco, Associate Editor
06.02.21
Cardiovascular
|
Surgical
Edwards Releases Sapien 3 Bicuspid Real-World Study Results
At one year, outcomes similar to overall cohort of patients.
Sam Brusco, Associate Editor
05.19.21
Cardiovascular
|
Surgical
Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data
There were no incidences of structural valve deterioration at the five-year mark.
Sam Brusco, Associate Editor
02.01.21
Cardiovascular
Edwards Treats First Patient in Restore Clinical Trial
Evaluates minimally invasive device for mitral valve disease.
Edwards Lifesciences Corp.
12.21.20
Cardiovascular
|
Surgical
Medtronic Begins TAVR Study Comparing Evolut Against Edwards' Sapien Valve
Also begins feasibility study of Evolut in moderate and asymptomatic aortic stenosis patients.
PR Newswire
10.14.20
Edwards Lifesciences
...
07.21.20
Cardiovascular
|
Surgical
FDA Approves Edwards' Konect Resilia Aortic Valved Conduit for Complex Surgeries
First ready-to-implant solution for bio-Bentall procedures.
PR Newswire
07.15.20
Abbott Agrees to Settlement with Edwards Lifesciences
All disputes related to transcatheter mitral and tricuspid repair products have been resolved.
PRNewswire
07.14.20
Cardiovascular
Edwards Pauses Enrollments in Pivotal Mitral, Tricuspid Trials
Decision was made in response to hospitals' focus on COVID-19.
PR Newswire
03.30.20
Surmodics Names New Vice President of Clinical Affairs
Former Edwards Lifesciences executive has more than 20 years of medical affairs, medtech, and healthcare experience.
Business Wire
03.13.20
Cardiovascular
Getting to the Heart of the Matter: An Examination of Transcatheter Heart Technologies
Transcatheter structural heart therapies stand to replace their open-heart counterparts thanks to technological innovations and expanded patient access.
Sam Brusco, Associate Editor
03.04.20
415 CAPITAL Closes New Medtech Venture Capital Fund
The fund will invest in medical device companies in Europe, Israel and the United States.
Business Wire
02.25.20
Edwards Lifesciences' Every Heartbeat Matters is Expanding
Plans to improve 2.5M patient lives by the end of 2025.
Edwards Lifesciences Corporation
02.21.20
United Biologics Appoints President and General Manager
New hire has brings over 20 years of experience in commercial leadership, primarily in the medical device industry.
Business Wire
11.07.19
Two Medical Device Executives Join JenaValve Executive Team
The pair bring a half century of experience in regulatory affairs and operational excellence to the company.
Business Wire
10.31.19
Microdermics Appoints CEO
New chief has more than three decades of rich experience across a variety of healthcare environments.
Globe Newswire
10.30.19
Cardiovascular
Corvia Medical, physIQ Partner for Global Phase 3 Heart Failure Clinical Trial
The 100-plus site trial is the first to leverage continuous multivariate wearable sensor data and artificial intelligence-based analytics.
Business Wire
10.24.19
Cardiovascular
|
Surgical
Admedus Turns Focus to TAVR Market
The company sold its CardioCel and VascuCel business to LeMaitre Vascular for up to $24.9M
GlobalData
10.23.19
Cardiovascular
|
Surgical
Edwards Invests $100M to Expand Operations in Costa Rica
The company expects to have 1,100 employees by the end of 2020 in its facility at La Lima Industrial Park in Cartago.
PR Newswire
10.11.19
Cardiovascular
Global Cardiac Implant Market Expected to Exceed $83.7 Billion in Six Years
Growth is anticipated from rising regulatory approvals for cardiac implant devices, which will result in an increasing number of product developments.
Business Wire
09.23.19
Cardiovascular
The TAVR Plot Thickens
Transcatheter aortic valve replacement (TAVR) surgery has typically targeted patients considered too risky to undergo open-heart surgery.
Sam Brusco, Associate Editor
09.06.19
Update on Integrated Delivery Networks and Physician Employment
The top five IDNs employ 135,913 MDs and DOs in the U.S., approximately 15 percent of all active physicians in the country.
Maria Shepherd, President and Founder, Medi-Vantage
09.06.19
Neurological
|
Patient Monitoring
Edwards ForeSight Technology Cleared by FDA
The only non-invasive indicator of brain oxygenization.
Edwards Lifesciences Corporation
08.29.19
Cardiovascular
|
Surgical
Edwards Recalls SAPIEN 3 Ultra Delivery System
Devices recalled due to burst balloons during surgery, which may result in vascular injury, bleeding, or surgical intervention.
U.S. Food and Drug Administration
08.22.19
Cardiovascular
Sapien 3 TAVR Receives FDA Approval for Low-Risk Patients
Now available for all patients diagnosed with severe, symptomatic aortic stenosis.
Edwards Lifesciences Corporation
08.19.19
The 2019 Top 30 Global Medical Device Companies
The lack of a significant megamerger in 2018 stood out in an industry that had become accustomed to annual blockbuster deals.
Sean Fenske, Michael Barbella, & Sam Brusco, MPO Editorial Staff
07.30.19
The 2019 Top 30 Global Medical Device Companies
...
Sean Fenske, Michael Barbella, & Sam Brusco, MPO Editorial Staff
07.30.19
11. Boston Scientific
...
07.30.19
Breaking News
Reprieve Cardiovascular Emerges From Stealth Mode With $42M Financing
Wearable Neuromodulation System for Urinary Incontinence Makes its Debut
Clinical Data Support Early Detection Ability of IR-MED's Pressure Injury Device
FineHeart Widens FlowMaker's International IP Protection
Encore Medical Device Repair Introduces Robotic Remanufacturing and Sustainability Program at HSPA
View Breaking News >
CURRENT ISSUE
April 2024
Medical Tubing & Extrusion Experts Offer Perspectives on Industry
Creating Sustainable Surfaces in Med Device Coating and Finishing
Man & Machine: Artificial Intelligence's Impact on Medtech
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