Tag: medtronic

FDA approves Evolut PRO+

The US Food and Drug Administration (FDA) has approved the Evolut PRO+ transcatheter aortic valve implantation (TAVI) system, which a press release states builds...

FDA approves Sapien 3 Ultra, Sapien 3, and CoreValve for low-risk...

On 16 August, the US Food and Drug Administration (FDA) approved Edwards Lifesciences’ Sapien 3 and Sapien 3 Ultra and Medtronic’s Evolut R and...

Medtronic enters into AI partnership for stroke care

Medtronic has entered into a partnership agreement with Viz.ai to accelerate the adoption of artificial intelligence software for stroke prevention and treatment in US...

Medtronic launches Telescope guide extension catheter

Medtronic recently announced the global launch of the Telescope guide extension catheter, a newly designed catheter used to provide additional backup support and access...

Targeted blood pressure management helps to reduce strokes in patients with...

An analysis on the impact of stroke severity in patients receiving the HeartWare HVAD system (Medtronic) as destination therapy shows that targeted blood pressure...

ACC 2019: TAVI moves to the mainstream with new findings in...

Evidence for the use of transcatheter aortic valve replacement (TAVI) as standard therapy is mounting, with the release of data from two major new...

CRT 2019: Evolut R superior to surgery at one year in...

A subanalysis from the SURTAVI trial has found that transcatheter aortic valve implantation (TAVI) with Evolut R in intermediate-risk patients has lower rates of...

US physicians can now use Resolute to treat chronic total occlusions

Medtronic has received US FDA approval of its Resolute drug-eluting stent platform—including the Resolute Onyx and Resolute Integrity—for the treatment of patients with coronary...

US FDA approve new study of Medtronic’s Spyral renal denervation system

The FDA have given Medtronic approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system in patients with hypertension who...

TCT 2018: Longest-term data to date for CoreValve study show excellent...

New data presented at 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA), according to a press release, patients implanted with the...

US FDA approve study of CoreValve Evolut in low-risk patients with...

The US FDA has approved an investigational device exemption (IDE) to initiate a single-arm study to evaluate the CoreValve Evolut transcatheter aortic valve implantation...

US FDA approval for SynchroMed II implantable system for treating pulmonary...

Medtronic has received US FDA approval for its implantable system for Remodulin to treat patients with pulmonary arterial hypertension. Through a first-of-its-kind collaboration, a...

US FDA classifies HeartWare HVAD power issues as a Class I...

The US FDA has classified Medtronic’s recent voluntary urgent field action related to the HeartWare HVAD system’s unexpected power source switching as a Class...

Use of Resolute Onyx to be explored for the treatment of...

Medtronic has announced the initiation of a clinical study in the US to assess the safety and efficacy of drug-eluting stents for the treatment...

Medtronic appoints Laura Mauri as vice president, Global Clinical Research &...

Medtronic has announced that Laura Mauri—interventional cardiologist and clinical researcher at the Brigham and Women's Hospital, and professor of medicine at Harvard Medical School—will...

Following FDA approval, Resolute Onyx 2mm becomes smallest stent on US...

Designed specifically for small vessels, the Resolute Onyx 2mm drug-eluting stent has received US FDA approval and, consequently, has been launched on to the...

“We really believe that the transradial approach is a better way...

The Society for Cardiovascular Angiography and Interventions (SCAI) has launched a new initiative, supported by Medtronic, called “Transition for value” that aims to help...

First patient implanted with Intrepid TMVI device in APOLLO trial

The first patient in the APOLLO trial has undergone transcatheter mitral valve implantation (TMVI) with the Intrepid device (Medtronic). The study—the first-ever pivotal trial...

Medtronic HeartWare HVAD approved for destination therapy

The US Food and Drug Administration (FDA) has approved Medtronic’s HeartWare HVAD system as a destination therapy for patients with advanced heart failure who...

From SYMPLICITY HTN-1 to SPYRAL HTN-OFF MED: The story of renal...

It is now almost a decade since the first patient underwent catheter-based renal denervation as a participant in a safety and proof-of concept study...

FORWARD PRO clinical study to evaluate longer term performance of CoreValve...

A new post-market clinical study is to evaluate Medtronic’s CoreValve Evolut Pro transcatheter aortic valve implantation (TAVI) valve in everyday clinical practice. Studying patients...

ESC 2017: SPYRAL HTN-OFF MED provides “proof of principle” that renal...

Results from SPYRAL HTN-OFF MED indicate that renal denervation, compared with a sham procedure, significantly reduces blood pressure in patients with hypertension who are...

Medtronic to undertake global randomised clinical trial of one-month DAPT in...

Medtronic has announced a global randomised clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT) in patients implanted with the Resolute Onyx drug-eluting...

Medtronic’s Avalus pericardial valve receives CE mark and FDA approval

Medtronic has announced CE mark and FDA approval of its new Avalus pericardial aortic surgical valve for the treatment of aortic valve disease.  According...

CE mark for CoreValve Evolut Pro

Medtronic has received the CE mark for its CoreValve Evolut Pro valve for the treatment of severe aortic stenosis for symptomatic patients who are...

Medtronic releases Resolute Onyx drug-eluting stent in Japan

Medtronic will release the Resolute Onyx coronary stent system in Japan. According to a press release, the device offers superior deliverability to that of...

EuroPCR 2017: No stent thrombosis with Resolute Onyx drug-eluting stent 2mm

Data for  the Resolute Onyx drug-eluting 2mm stent (Medtronic), which were presented at EuroPCR (16–19 May, Paris, France), indicate that device is not associated...

EuroPCR 2017: Excellent clinical outcomes for Medtronic’s CoreValve and Evolut systems...

New positive data on the self-expanding Medtronic CoreValve platform from the CoreValve ADVANCE and Evolut R FORWARD clinical studies—two large, rigorous global registries—have been...

FDA approves Medtronic’s Resolute Onyx drug-eluting stent

The FDA has approved Medtronic’s Resolute Onyx drug-eluting stent, which the company has now launched in the USA. “As stent technologies continue to evolve, recent...

US FDA designates Medtronic HVAD system controller field action as class...

The US Food and Drug Administration (FDA) has classified Medtronic’s recently initiated voluntary field action related to its HVAD system controllers and direct current...

LATERAL study offers positive overall results for Medtronic HVAD

Preliminary results from the Medtronic -sponsored HVAD LATERAL study have demonstrated overall positive results. The data were presented as a late breaking clinical trial...

Medtronic ENDURANCE Supplemental trial of HVAD fails to meet primary endpoint

Medtronic’s ENDURANCE Supplemental trial of the company’s HVAD ventricular assist device has failed to meet its primary endpoint of all neurological events at 12...

TAVI pacemaker issue is “an engineering problem that will be solved”

The SURTAVI trial indicates that transcatheter aortic valve implantation (TAVI)  with CoreValve/CoreValve Evolut R (Medtronic) is non-inferior to surgery for the management of severe...

ACC 2017: CoreValve non-inferior to surgery in intermediate-risk patients

Results from the SURTAVI clinical trial, which were presented today at the 2017 scientific sessions of the American College of Cardiology (17–19 March, Washington,...

Medtronic launches Impact education and development programme in Europe, Middle East...

Medtronic has announced the launch of Medtronic Impact in the Europe, Middle East & Africa regions. Medtronic Impact is intended to introduce a new approach...

Medtronic releases DxTerity diagnostic catheters and transradial approach tool

  Medtronic has launched the DxTerity diagnostic angiography catheter line, and several transradial-specific products including the DxTerity TRA, InTRAkit access kit and TRAcelet compression device,...

Medtronic receives CE mark for 34mm size CoreValve Evolut R

The CE mark has been granted to Medtronic for the 34mm-valve version of its CoreValve Evolut R, the largest sized transcatheter aortic valve implantation...

Japan’s Ministry of Health, Labor and Welfare approves reimbursement for Medtronic’s...

Medtronic has been granted reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its recapturable, self-expanding transcatheter CoreValve Evolut R...

Medtronic first to receive CE mark for less-invasive HVAD implant procedure

Medtronic’s HVAD system left ventricular assist device (LVAD) has received the CE mark for a less-invasive implant procedure in patients with advanced heart failure....

TCT 2016: First-in-human data shows Medtronic’s drug-filled stent to be non-inferior...

Results of the REVELUTION study, simultaneously presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October-2 November, Washington, DC, USA) and published in...

FDA approval of 34mm CoreValve Evolut R means device is largest...

Medtronic has announced the FDA approval and US launch of the CoreValve Evolut R 34mm valve—the largest sized transcatheter aortic valve implantation (TAVI) system...

Health Canada grants licence to Medtronic for its CoreValve Evolut R...

Medtronic Canada has announced it has received a Health Canada licence for its recapturable, self-expanding CoreValve Evolut R System. A press release reports that...

EACTS 2016: Positive one-year outcomes for Medtronic’s surgical aortic valve Avalus

Positive clinical data for Medtronic’s investigational Avalus pericardial aortic surgical valve were presented yesterday at the 2016 European Cardio-Thoracic Surgery (EACTS) annual meeting (1-5...

Medtronic ranks on Dow Jones Sustainability North America Index for ninth...

Medtronic has been recognised as one of the world's leading companies for sustainability, ranking on the Dow Jones Sustainability North America Index (DJSI North...

Purchase of HeartWare by Medtronic completed

Medtronic has completed its acquisition of HeartWare International—a developer of less-invasive, miniaturised, mechanical circulatory support technologies for treating patients with advanced heart failure. HeartWare...

Renal denervation devices are alternatives to drug therapy, Technavio reports

Analysts from Technavio have forecast the global renal denervation market to grow at a compound annular growth rate of close to 12% during the...

Medtronic CoreValve Evolut becomes first TAVI to receive CE mark for...

Medtronic has received CE marking for the self-expanding, recapturable and repositionable CoreValve Evolut R system to treat aortic stenosis patients who are at intermediate...