Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  Nyse  >  Medtronic plc    MDT   IE00BTN1Y115

MEDTRONIC PLC

(MDT)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsPress ReleasesOfficial PublicationsSector newsMarketScreener StrategiesAnalyst Recommendations

Medtronic : Venous Stent Receives U.S. FDA Approval to Treat Venous Outflow Obstruction

10/27/2020 | 08:46am EST

DUBLIN - Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval for the Abre venous self-expanding stent system.

This device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction, also known as deep venous obstruction.

Deep venous obstruction occurs when the veins in the deep venous system become obstructed, blocked and/or compressed causing restricted blood flow to the heart. If left untreated, patients can experience leg discomfort and pain, limiting their mobility and quality of life. Symptoms of the disease include leg swelling, skin changes, leg ulcers, and pain. Severe complications can occur, such as blood clots that migrate to the lungs (pulmonary embolism), a clot in the leg called a deep vein thrombosis (DVT), or the formation of fibrotic tissue or scarring caused by a chronic DVT (post thrombotic syndrome).

The FDA approval is based on 12-month results from the ABRE clinical study, presented at the 2020 Charing Cross Symposium. The ABRE study assessed the safety and effectiveness of the investigational Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of deep venous obstruction including those with post thrombotic syndrome, non-thrombotic iliac vein lesions (NIVL), and those who presented with an acute deep vein thrombosis (aDVT). The study also included a challenging patient population, 44% (88/200) of whom required stents that extended below the inguinal ligament into the common femoral vein (CFV). The study met its primary safety endpoint with a 2.0% (4/200) rate of major adverse events (MAEs) within 30 days.1 The study also met its 12-month primary effectiveness endpoint with an overall primary patency rate of 88.0% (162/184).2 Despite the challenging patient population, no stent fractures and no stent migrations were reported in the study.

'Patients with deep venous obstruction are often younger, therefore it's critical to have a venous stent that is not only safe and effective, but also strong and flexible,' said Erin Murphy, M.D., F.A.C.S., global principal investigator for the ABRE clinical study and director of Atrium Health Sanger Heart & Vascular Institute's Venous and Lymphatic Program in Charlotte, North Carolina. 'With FDA approval, we now have this important tool in our arsenal to treat patients with even the most challenging of deep venous lesions.'

A self-expanding stent system, Abre is intended for permanent implant and utilizes an open-cell design with three off-set connection points to enable flexibility and stability during deployment. Abre also offers a balance of strength, flexibility, and fatigue resistance. Based on data presented at the Leipzig Interventional Course (LINC) 2020 annual meeting by Stephen Black, M.D., consultant and vascular surgeon, Guy's, and St. Thomas' Hospital and Kings College in London, the Abre stent system demonstrated a 0% fracture rate in bench testing simulated out to 50 years.3

'With Abre, our goal was to create a dedicated venous stent that combined a balance of the key characteristics necessary to treat patients with a broad spectrum of deep venous obstruction,' said Carolyn Sleeth, vice president and general manager of the endoVenous business, which is part of the Cardiac and Vascular Group at Medtronic. 'We are excited to bring Abre to the U.S. market, which we believe will provide both physicians and patients with a new option backed by clinical evidence to treat this disease safely and effectively.'

Abre received CE (Conformite Europeene) Mark approval in April of 2017 and is also intended for use in the iliofemoral veins for treatment of symptomatic venous outflow obstruction.

In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic

Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contact:

Julia Fuller

Tel: +1-707-210-2069

(C) 2020 Electronic News Publishing, source ENP Newswire

All news about MEDTRONIC PLC
01/15MEDTRONIC : NANS 2021 Neuromodulation Investor Briefing
PU
01/15MEDTRONIC : Launches First-of-Its-Kind Adaptive Deep Brain Stimulation Trial in ..
AQ
01/14MEDTRONIC : Starts Adaptive Deep Brain Stimulation Trial in Parkinson's Disease ..
MT
01/14MEDTRONIC : Launches First-of-Its-Kind Adaptive Deep Brain Stimulation (aDBS) Tr..
AQ
01/13Intel Ousts Chief Executive Bob Swan -- 5th Update
DJ
01/13Intel Ousts Chief Executive Bob Swan -- 4th Update
DJ
01/13BRIAN KRZANICH : Intel taps VMware's Gelsinger as CEO to fix manufacturing crisi..
RE
01/13Intel Ousts Chief Executive Bob Swan -- 3rd Update
DJ
01/13Intel Ousts Chief Executive Bob Swan -- 2nd Update
DJ
01/13Intel Ousts Chief Executive Bob Swan -- Update
DJ
More news
Financials (USD)
Sales 2021 29 943 M - -
Net income 2021 3 471 M - -
Net Debt 2021 20 541 M - -
P/E ratio 2021 45,2x
Yield 2021 1,93%
Capitalization 157 B 157 B -
EV / Sales 2021 5,94x
EV / Sales 2022 5,38x
Nbr of Employees 90 000
Free-Float 99,9%
Chart MEDTRONIC PLC
Duration : Period :
Medtronic plc Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends MEDTRONIC PLC
Short TermMid-TermLong Term
TrendsBullishBullishBullish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 27
Average target price 128,88 $
Last Close Price 116,81 $
Spread / Highest target 28,4%
Spread / Average Target 10,3%
Spread / Lowest Target -1,55%
EPS Revisions
Managers and Directors
NameTitle
Geoffrey Straub Martha Chairman & Chief Executive Officer
Mark Ploof Senior VP-Global Operations & Business Services
Karen L. Parkhill Chief Financial Officer & Executive Vice President
Richard E. Kuntz Senior VP, Chief Scientific & Clinical Officer
Richard H. Anderson Independent Director
Sector and Competitors
1st jan.Capitalization (M$)
MEDTRONIC PLC-0.28%157 229
ABBOTT LABORATORIES1.65%190 701
BECTON, DICKINSON AND COMPANY4.60%76 127
HOYA CORPORATION-2.24%50 041
ALIGN TECHNOLOGY, INC.6.15%44 726
BAXTER INTERNATIONAL INC.-0.25%40 886