News - Page 4 of 6 - Cardiovascular News

In revised recommendations, the American Academy of Neurology (AAN) states that catheter-based closure should not be routinely recommended for people who have had a stroke and also have patent foramen ovale (PFO). The practice advisory, which updates a previous AAN guideline, has been published in Neurology.

Oral abstract on DuraGraft to be presented at EACTS

29th July 2016

Miguel Haime (VA Boston Healthcare System and Boston Medical Center, Boston, USA) is to present an abstract about Somhulation's DuraGraft during a rapid response session at the 2016 annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS; 1–5 October, Barcelona, Spain).

ClearFlow launches smaller PleuraFlow active clearance technology for paediatric use

27th July 2016

After receiving clearance from the US Food & Drug Administration (FDA) earlier this year for expanded Indications for Use with the company's patented technology, ClearFlow has developed a new model of the PleuraFlow product for the paediatric market.

US FDA releases draft guidance on real-world evidence and medical device regulation decisions

27th July 2016

According to an email from the consumer watchdog, the document is intended to clarify "how the FDA determines that real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the evidentiary standards we use to make those decisions."

Providence Health Care adopts HeartFlow FFRct Analysis to assess coronary artery disease

25th July 2016

Providence Health Care has become the first centre in Canada to adopt the HeartFlow FFRct Analysis, and also first in the world to use the next generation version of the platform. The HeartFlow FFRct Analysis, which was recently approved by Health Canada, is a non-invasive technology used by clinicians to assess their patients for coronary artery disease.

New website for Xenios

21st July 2016

Xenios AG, a developer of lung and heart assist therapies, has combined its novalung, i-cor, and medos websites into www.xenios-ag.com to further advance the Xenios platform. With the new Xenios website, the Heilbronn-based medical device company further advances its lung and heart assist therapy platform.

First patient enrolled in left main study of Xposition S

20th July 2016

Stentys has started to enrol patients in its TRUNC trial, which is designed to evaluate the long-term safety and efficacy of the Xposition S stent in the treatment of unprotected left main coronary artery disease.

TAVI durability: A rose by any other name is still a rose

20th July 2016

The data that Dvir presented at EuroPCR, as reported by Cardiovascular News, indicate that there is a significant increase in valve degeneration between five and seven years after a transcatheter aortic valve implantation (TAVI) device is implanted.

Study indicates signal for valve degeneration in TAVI patients by eight years

20th July 2016

Speaking at EuroPCR (17–20 May, Paris, France), Danny Dvir reported that there is a significant increase in valve degeneration between five and seven years after a transcatheter aortic valve implantation (TAVI) device is implanted.

Manta large bore vascular closure device now approved in Europe

19th July 2016

Essential Medical has received CE mark approval for Manta; its large bore vascular closure device. The device is a novel vascular closure device designed to close punctures ranging from 10F to 24F at femoral arterial access sites after cardiac catheterisation procedures such as TAVI.

Moderate risk of upper gastrointestinal bleeding after TAVI

19th July 2016

A large cohort study, published in Catheterization and Cardiovascular Interventions, indicates that TAVI is associated with an overall 2% risk of upper gastrointestinal bleeding.

Robotic-assisted PCI is safe and feasible for complex procedures

19th July 2016

Results from the CORA-PCI (Complex robotically assisted percutaneous coronary intervention) indicate that robotic-assisted percutaneous coronary intervention (PCI), using the CorPath system (Corindus Vascular Robotics), is a safe and feasible approach to managing patients with complex lesions.

Safety and efficacy of Carillon mitral contour system confirmed

19th July 2016

According to a study published in Open Heart, treatment with the Carillon device (Cardiac Dimensions) significantly reduces annular dimensions and improved mitral regurgitation, heart failure symptoms, and functional capacity in patients with functional mitral regurgitation.

Health Canada approves Abbott Absorb stent

18th July 2016

Health Canada has approved Abbott's Absorb bioresorbable heart stent, making the device commercially available to treat people in Canada with coronary artery disease.

AHA warn that some over-the-counter drugs may cause or worsen heart failure

18th July 2016

Commonly used medications and nutritional supplements may cause or worsen heart failure, according to the first scientific statement from the American Heart Association (AHA) to provide guidance on avoiding drug-drug or drug-condition interactions for people with heart failure.

Enrolment completed in US early feasibility study on tricuspid repair

14th July 2016

Mitralign has announced that enrolment in the first phrase of its SCOUT study, which is evaluating percutaneous tricuspid repair with the Trialign system in patients with functional tricuspid regurgitation, has been completed.

“Strikingly higher” survival rates with Sapien 3 at one year compared with older devices

13th July 2016

Overall one-year survival was over 85% for high-risk or inoperable patients who underwent transcatheter aortic valve implantation (TAVI) with Sapien 3, according to a study published in Circulation.

First single monthly injection of a PCSK9 Inhibitor approved in the USA

12th July 2016

Amgen has received FDA approval for its Repatha (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. The Pushtronex system is a hands-free device designed to provide 420mg of Repatha in a single dose.

Sunshine Heart to focus on neuromodulation for heart failure

12th July 2016

Sunshine Hearth has updated its clinical strategy, which it says could benefit an under-served population of patients with Class III heart failure and other related conditions. The company is moving forward with a therapeutic strategy focused on neuromodulation rather than counterpulsation.

Essential Medical to begin US clinical trial of its large bore vascular closure device

12th July 2016

Essential Medical has received IDE approval from the FDA to begin the US clinical trial of its large bore vascular closure device (Manta). The study will evaluate the safety and efficacy of vascular access closure using Manta for femoral arterial access site.

Heart failure after first myocardial infarction linked to cancer

12th July 2016

A study published in the Journal of the American College of Cardiology (JACC) indicates that patients who develop heart failure after their first myocardial infarction have a greater risk of developing than those who do not develop heart failure after a first myocardial infarction.

Exploring the borders of TAVI

11th July 2016

The NOTION 2 trial, which recently enrolled a 64-year-old female with Society of Thoracic Surgeon (STS) score 1.2% as its first patient, is comparing the use of TAVI with the use of surgical aortic valve replacement in patients aged â‰¤75 years at low surgical risk.

Combined percutaneous treatment of aortic stenosis and mitral regurgitation is feasible

8th July 2016

Martina PatanÃ© and colleagues found that percutaneous edge-to-edge repair (MitraClip, Abbott Vascular), either as a planned staged treatment or as a bailout therapy, is feasible and effective approach in mitral regurgitation patients who have undergone TAVI.

CE mark for QT Vascular’s Chocolate Heart drug-coated balloon

7th July 2016

QT Vascular has received CE mark clearance for the sale and distribution of its Chocolate Heart drug-coated balloon for dilatation of the stenotic portion of coronary arteries for the purpose of improving myocardial perfusion in Europe.

Cardiovascular Systems submits Diamondback 360 Coronary Orbital Atherectomy System Micro Crown for approval in Japan

7th July 2016

Cardiovascular Systems Inc (CSI) has submitted an application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for approval of its Diamondback 360 Coronary Orbital Atherectomy System Micro Crown to treat severely calcified coronary arteries for the facilitation of stent placement.

Versa Capital Management to acquire SynCardia Systems

6th July 2016

SynCardia Systems has entered into an asset purchase agreement with an affiliate of Versa Capital Management to acquire substantially all of the company's assets and operations, bringing with it the ability to provide the capital necessary for SynCardia to realise its full potential as the world's first and only FDA, provider of the Total Artificial Heart and drivers.

Study confirms safety of using Tryton stent to treat coronary bifurcation lesions involving large side branches

6th July 2016

The Tryton Confirmatory Study, recently published in JACC Cardiovascular Interventions, has confirmed the safety and efficacy of the Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches (appropriate for a â‰¥2.5mm stent).

CorPath to be featured at San Diego Cardiovascular Interventions Course

6th July 2016

Corindus Vascular Robotics' CorPath system will be highlighted in several presentations on new therapies and techniques for the treatment of high-risk patients with complex cardiovascular disease at the San Diego Cardiovascular Interventions Course (SDCI; 8–9 July, San Diego, USA).

Absorb now available in the USA following FDA approval

5th July 2016

Five years after receiving the CE mark, Abbott Vascular’s bioresorbable ...

First patient treated in NOTION-2 trial of TAVI in younger patients

4th July 2016

A 64-year old female with severe aortic stenosis and low surgical risk (STS score 1.2%) has been treated at Rigshospitalet in Copenhagen, Denmark, with transcatheter aortic valve implantation (TAVI), becoming the first patient in the NOTION-2 trial.

High prevalence of delirium found in cardiac arrest patients with therapeutic hypothermia

4th July 2016

A study published in the American Journal of Critical Care has found a high prevalence of delirium in a small cohort of critically ill patients treated with therapeutic hypothermia after cardiac arrest.

Industry-sponsored meals linked to increased rate of prescribing brand-name drugs

1st July 2016

A study, published in the JAMA: Internal Medicine, indicates that doctors who receive industry-sponsored meals have higher rates of brand-name drug prescriptions than alternative options within the same drug class.

RenalGuard features in high-risk live case at CTO Fundamentals Course

28th June 2016

RenalGuard Solutions has been featured in a high-risk coronary chronic total occlusion (CTO) live case presentation at the recent CTO Fundamentals Course, June 3, 2016, VU University Medical Center, Amsterdam, The Netherlands.

Bioventrix receives CE marking for Revivent TC system

28th June 2016

BioVentrix has received certification for CE marking its Revivent TC transcatheter ventricular enhancement system.

Twisting of the heart may predict mitral valve surgery outcomes

28th June 2016

A simple preoperative echocardiographic measurement of the amount of torsion of the heart predicted outcomes of mitral valve surgery in some heart failure patients, according to a novel study published in JACC: Basic to Translational Science.

FDA clears QT Vascular Chocolate XD balloon

28th June 2016

QT Vascular, together with its subsidiaries, has receivedFDA 510(k) clearance for the Chocolate XD percutaneous transluminal coronary angioplasty catheter for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.

Trials on newer generation drug-eluting stents in small coronary vessels needed

27th June 2016

A network meta-analysis of early generation, drug-eluting stents, bare metal stents, drug-coated balloons, and balloon angioplasty indicate that sirolimus-eluting stents are associated with the most favourable angiographic and clinical outcomes for lesions in small coronary arteries.

Prior radiation therapy is associated with increased risk of mortality in PCI patients

27th June 2016

Grant W Reed, Milind T Desai and others report that prior external beam radiation therapy is an independent predictor of both all-cause and cardiovascular mortality in patients undergoing PCI.

Next-generation of HeartFlow launched

24th June 2016

HeartFlow has announced that it has launched its next generation of its HeartFlow FFRct system. The result of years of development, the next-generation platform includes major advancements in the process and algorithms HeartFlow uses to calculate fractional flow reserve computed tomography.

Success of TAVI prompts surge in mitral valve technologies

23rd June 2016

Initially designed as a treatment for inoperable patients with aortic st...

Online medical information: A blessing or a curse?

23rd June 2016

The internet age has enabled patients to access a plethora of medical information. However, a potential drawback is that some of this information is inaccurate or misleading, causing unnecessary anxiety or false hope to patients.

First patients treated with CorMatrix Cardiovascular Tyke

22nd June 2016

The first patients have been treated using CorMatrix Cardiovascular’s Tyke. T...

First patient enrolled in AtriCure FROST cryoanalgesia study

22nd June 2016

The first patient has been enrolled in the FROST study at William Beaumont Hospi...

$Small study finds positive results for Neovasc’s Reducer system treatment for refractory angina$

Small study finds positive results for Neovasc’s Reducer system treatment for refractory angina

22nd June 2016

Positive results of a single-centre, retrospective study using the Neovasc Reduc...

Immune system linked to lower heart attack risk, suggests study

22nd June 2016

Measuring antibody levels in the blood could be used to detect a person’s he...

St Jude Medical HeartMate 3 wins CARDIOSTIM-EHRA EUROPACE 2016 Innovation Award

22nd June 2016

St Jude Medical has received an Innovation Award for its HeartMate 3 left ve...

Biotronik’s scaffold is now approved for use in Europe

22nd June 2016

Biotronik’s bioresorbable magnesium scaffold—Magmaris—is now CE mark approve...

First patients treated with CorMatrix Cardiovascular Tyke

22nd June 2016

The product received US Food and Drug Administration 510(k) clearance in February 2016. It is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defects and annulus repair, suture-line buttressing, and cardiac repair.

First patient enrolled in AtriCure FROST cryoanalgesia study

22nd June 2016

The first patient has been enrolled in the FROST study at William Beaumont Hospital, Dearborn, USA. This AtriCure-sponsored trial will evaluate intraoperative cryoanalgesia therapy using cryoablation in conjunction with standard of care (SOC) pain management compared to SOC alone.

Cardiac & Vascular Institute becomes first North Central Florida cardiologist group to offer Watchman LAAC implant

22nd June 2016

The Cardiac & Vascular Institute is the first organisation in the Nort...

Cardiovascular News Issue 41 – May 2016

21st June 2016

Highlights - TAVI with Sapien 3 may be better than surgery for intermediate-risk...

Cardiovascular News Issue 41 – May 2016 US Edition

21st June 2016

Highlights - TAVI with Sapien 3 may be better than surgery for intermediate-risk...

Cardiovascular News Issue 40 – February 2016 US Edition

21st June 2016

Highlights - ABSORB III supports previous findings that Absorb is noninferior to...

Cardiovascular News Issue 40 – February 2016

21st June 2016

Highlights - ABSORB III supports previous findings that Absorb is noninferior to...

Cardiovascular News Issue 39 – October 2015

21st June 2016

Highlights - Novel diagnostic strategy may "dramatically reduce need for invasiv...

Cardiovascular News Issue 39 – October 2015 US edition

21st June 2016

Highlights - Novel diagnostic strategy may "dramatically reduce need for invasiv...

Cardiovascular News Issue 38 – August 2015

21st June 2016

Highlights: -Sapien XT and CoreValve have comparable mortality at one year -Curr...

Cardiovascular News Issue 38 – August 2015 US Edition

21st June 2016

Highlights: -Sapien XT and CoreValve have comparable mortality at one year -Curr...

Cardiovascular News Issue 37 – May 2015 US Edition

21st June 2016

Highlights: -In BEST, surgery is still top option for multivessel disease -Two-y...

Cardiovascular News Issue 37 – May 2015

21st June 2016

Highlights: -In BEST, surgery is still top option for multivessel disease -Two-y...

Cardiovascular News Issue 36 – February 2015

21st June 2016

Highlights: -More data needed for routine use of TAVI in lower risk patients -Fi...

Cardiovascular News Issue 36 – February 2015 US Edition

21st June 2016

Highlights: -More data needed for routine use of TAVI in lower risk patients -Fi...

Cardiovascular News Issue 35 – September 2014

21st June 2016

Highlights: -European guidelines lower duration of dual antiplatelet therapy to ...

Cardiovascular News Issue 35 – September 2014 US Edition

21st June 2016

Highlights: -European guidelines lower duration of dual antiplatelet therapy to ...

Cardiovascular News Issue 34 – August 2014

21st June 2016

Highlights: -Staged intervention is right way to treat STEMI patients with multi...

Cardiovascular News Issue 34 – August 2014 US Edition

21st June 2016

Highlights: -Staged intervention is right way to treat STEMI patients with multi...

Cardiovascular News Issue 33 – May 2014

21st June 2016

Highlights: - Renal denervation comes to a "grinding halt" but studies will cont...

Cardiovascular News Issue 33 – May 2014 US Edition

21st June 2016

Highlights: - Renal denervation comes to a "grinding halt" but studies will cont...

Cardiovascular News Issue 32 – February 2014

21st June 2016

Highlights: -Major setback for renal denervation -Long-term dual antiplatelet th...

Cardiovascular News Issue 32 – February 2014 US Edition

21st June 2016

Highlights: -Major setback for renal denervation -Long-term dual antiplatelet th...

Cardiovascular News Issue 31 – October 2013

21st June 2016

Highlights: -Preventative angioplasty in non-infarct arteries benefits STEMI pat...

Cardiovascular News Issue 31 – October 2013 US Edition

21st June 2016

Highlights: -Preventative angioplasty in non-infarct arteries benefits STEMI pat...

Cardiovascular News issue 30 – August 2013

21st June 2016

Highlights: -Six to 12 months is the right timeframe for dual antiplatelet thera...

Cardiovascular News issue 30 – August 2013 US edition

21st June 2016

Highlights: -Six to 12 months is the right timeframe for dual antiplatelet thera...

Cardiovascular News issue 29 – May 2013

21st June 2016

Highlights: Cangrelor significantly reduces ischaemic events compared with clopi...

Cardiovascular News issue 29 – May 2013 US edition

21st June 2016

Highlights: Cangrelor significantly reduces ischaemic events compared with clopi...

Valcare completes first phase of first-in-human Amend trial

21st June 2016

Valcare Medical, an Accelmed portfolio company has successfully completed the first phase of its first-in-human (FIH) multicentre clinical trial, taking place in Israel and Europe.

First patient enrolled in Keystone Heart Triguard study

21st June 2016

The device is being assessed for its ability to protect the brain from emboli during transcatheter aortic valve implantation (TAVI), minimising the risk of cerebral damage. The study, REFLECT, is a multicentre, phase 2/3, randomised, interventional, single-blind clinical study.

Percutaneous direct annuloplasty is “safe and feasible” for functional mitral regurgitation

21st June 2016

Georg Nickenig and others report in the Journal of the American College of Cardiology that the Mitralign percutaneous annuoplasty system (MPAS, Mitralign) is a feasible and safe treatment for high-risk patients with functional mitral regurgitation.

Cardiovascular News Issue 27 – October 2012 US edition

20th June 2016

Highlights: -TRILOGY-ACS shows no advantage for prasugrel over clopidogrel ...

Cardiovascular News Issue 27 – October 2012

20th June 2016

Highlights: -TRILOGY-ACS shows no advantage for prasugrel over clopidogrel ...

Cardiovascular News Issue 26 – August 2012 US edition

20th June 2016

Highlights: -The future of renal denervation rests on selecting the right patien...

Cardiovascular News Issue 26 – August 2012

20th June 2016

Highlights: -The future of renal denervation rests on selecting the right patien...

Cardiovascular News Issue 25 – May 2012

20th June 2016

Highlights: -TAVI as effective as surgery in high-risk patients at two years -Su...

Cardiovascular News Issue 24 – February 2012 EU edition

20th June 2016

Highlights: -iFR vasodilator-free measure of stenosis severity comparable to FF...

Cardiovascular News Issue 24 – February 2012 US edition

20th June 2016

Highlights: -iFR vasodilator-free measure of stenosis severity comparable to FF...

Cardiovascular News Issue 23 – November 2011

20th June 2016

Highlights: -Lower thrombosis risk with newer generation drug-eluting stents -...

Cardiovascular News Issue 22 – August 2011

20th June 2016

Highlights: -FFR-CT technique can cut unnecessary coronary procedures -"TAVI s...

Cardiovascular News Issue 21 – May 2011

20th June 2016

Highlights: -PARTNER find TAVI as good as surgery -Absorb shows positive one-y...

Cardiovascular News Issue 20 – Feb 2011

20th June 2016

Highlights - New absorbable stent era begins - TAVI improves quality of life i...

Cardiovascular News Issue 19 – Sept 2010

17th June 2016

Highlights - ESC sees SHIFT in heart failure treatment - FDA advisory committe...

Cardiovascular News Issue 18 – Jul 2010

17th June 2016

Highlights - "Encouraging" TAVI results in high-risk patients - Bioresorbable ...

Cardiovascular News Issue 17 – Apr 2010

17th June 2016

Highlights - NO ACCORDance on role of fibrates - Cypher versus ENDEAVOR trial ...

Cardiovascular News Issue 16 – Jan 2010

17th June 2016

Highlights - Controversy surrounds long-term lipid lowering therapy - SPIRIT I...

Cardiovascular News Issue 15 – Sep 2009

17th June 2016

Highlights - New drugs steal the spotlight at the ESC Congress - SYNTAX at two...

Cardiovascular News Issue 14 – Aug 2009

17th June 2016

Highlights - Drug-eluting stents "warranted" for infarction - Syntax Score web...

Cardiovascular News Issue 13 – May 2009

17th June 2016

Highlights - Percutaneous mitral valve repair takes off - Antiplatelet agent p...

Cardiovascular News Issue 12 – Jan 2009

17th June 2016

Highlights - JUPITER: reduced events in patients with low LDL cholesterol, rais...

Investigational trial into Medtronic CoreValve Evolut R 34mm enrols first patient

16th June 2016

PinnacleHealth (East Cowes, USA) has enrolled the first patient nationally in a new clinical trial investigating a larger size of the Medtronic CoreValve Evolut R system, the Evolut R 34mm system.

Transcatheter tricuspid valve repair successfully achieved in feasibility study of 4Tech TriCinch

16th June 2016

4Tech has announced that its TriCinch device has been used to successfully treat patients suffering from tricuspid regurgitation. The ongoing feasibility study is being conducted at San Raffaele Hospital (Milan, Italy) and in other sites in Italy and Europe.

A quarter of an hour of exercise per day may reduce risk of death in older adults

15th June 2016

A study, which was presented at EuroPRevent 2016 (14–15 June, Sophia Antipolis, ...

Biotronik’s scaffold is now approved for use in Europe

15th June 2016

Biotronik's bioresorbable magnesium scaffold, Magmaris, is now CE mark approved, meaning it is now one of three bioresorbable scaffolds available on the European market (alongside Abbott Vascular's Absorb and Elixir Medical's Desolve.

Risk of device thrombosis may be significantly higher with Absorb than with Xience, Promus or Orsiro

14th June 2016

A network meta-analysis, published in JACC: Cardiovascular Interventions, in...

Minor short-term mortality benefit with vascular closure devices

10th June 2016

Vasim Farooq and others report in Circulation Cardiovascular Interventions that the use of a vascular closure device after transfemoral PCI is associated with a minor short-term mortality benefit compared with manual compression.

NYU Langone becomes first centre in world to use Evolut PRO TAVI system

9th June 2016

The Cardiothoracic Surgery Department's Heart Valve Center at NYU Langone Medical Center became the first centre in the world to implant a new heart valve for TAVI in a patient with severe aortic stenosis.

CE mark for longest version of Xposition S sirolimus-eluting stent

9th June 2016

Stentys has announced that it has received the CE mark for the longest version (37mm) of its Xposition S sirolimus-eluting self-apposing stent. The approval of this longer version means that interventional cardiologists will now only need to implant a single self-apposing stent (in relevant longer lesions) rather than a long conventional stent, thus minimising the risk of malapposition and related complications.

“Encouraging” results for transcarotid TAVI

9th June 2016

Darren Mylotte and his co-authors report that TAVI with transcarotid access is "feasible and is associated with encouraging short- and medium-term clinical outcomes". In this interview, he explains the need for an alternative access approach to transfemoral and reviews the potential benefits of transcarotid access.

Go “slender” to reduce the rate of radial artery occlusions

9th June 2016

Giovanni Amoroso (Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands) is involved in developing the slender transradial interventions concept, which focuses on the maximal miniaturisation of transradial coronary interventions.

Heart bleeds associated with severity of heart failure

8th June 2016

The amount a heart "bleeds" following a myocardial infarction can predict the severity of future heart failure, according to research presented at the British Cardiovascular Society (BCS) conference (6–8 June, Manchester, UK). The researchers have now found that this injury is associated with a higher risk of developing heart failure in the months following a heart attack.

Marriage is good for the heart

8th June 2016

Being married could improve your likelihood of surviving a myocardial infarction and is associated with reduced length of hospital stay, according to research presented at the British Cardiovascular Society (BCS) Conference (6–8 June, Manchester, UK).

A new percutaneous approach for managing mitral valve regurgitation

8th June 2016

Last year, the Cardioband mitral reconstruction system (Valtech) was approved in Europe for mitral valve repair. It joins MitraClip (Abbott Vascular) as one of the few options available for patients with mitral regurgitation who are unable to undergo surgery because of a high risk of complications.

Karl-Heinz Kuck steps down from the ESC and EHRA after fraud conviction

8th June 2016

Karl-Heinz Kuck has withdrawn his candidacy for president-elect of the European Society of Cardiology (ESC) and also resigned from board of the European Heart Rhythm Association (EHRA). This follows a conviction for fraud.

A new percutaneous approach for managing mitral valve regurgitation

8th June 2016

Last year, the Cardioband mitral reconstruction system (Valtech) was approved in Europe for mitral valve repair. It joins MitraClip (Abbott Vascular) as one of the few options available for patients with mitral regurgitation who are unable to undergo surgery because of a high risk of complications.

Reducing aggressive and rude communication helps both doctors and patients

8th June 2016

While profoundly overworked clinical teams may understandably be reluctant to accept another referral, aggressive, rude or dismissive communication negatively affects both staff and patients. Benjamin C Whitelaw reviews the steps that can be taken to reduce such behaviour.

The risk of acute kidney injury during complex cardiac interventions: Rationale of the STRENGTH study

8th June 2016

Although most patients undergoing complex cardiac or vascular interventions tolerate contrast, some will develop contrast-induced acute kidney injury-which is associated with increased mortality. In this commentary, Philippe Garot and Andrew Roy review the aims and objectives of the ongoing STRENGTH trial.

James Blankenship

8th June 2016

James Blankenship is the 2015-2016 president of SCAI and has been involved with designing and implementing the society's new strategic plan. He talks to Cardiovascular News about the plan and how climbing Kilimanjaro with his three children was a good reminder of what matters most in life.

New “harvesting heroes” campaign to recognise work of healthcare professionals working in cardiac surgery

7th June 2016

In collaboration with APACVS, the Getinge Group has launched a new "Harvesting Heroes" campaign. The campaign seeks to recognise healthcare professionals in the field of cardiac surgery as well as celebrate 20 years since the endoscopic vessel harvesting technique was pioneered.

Permaseal transapical access and closure device now approved in Europe

7th June 2016

Micro Interventional Devices has received the CE mark for its Permaseal transapical access and closure device. The device allows surgeons to access and close the left-ventricle instantaneously, reliably and without suturing the myocardium.

Study shows women with migraines to be at higher risk of cardiovascular disease and mortality

6th June 2016

Women diagnosed with migraines have a slightly increased risk of developing cardiovascular diseases, such as heart attacks and strokes, and are somewhat more likely to die from these conditions than women who do not have migraine, according to findings of a large study published in The BMJ.

The Medicines Company completes patient enrolment for ORION-1 study of PCSK9si

6th June 2016

Patient enrolment has been completed in The Medicine Company's ORION-1 study of PCSK9si, its investigational RNA interference (RNAi) proprotein convertase subtilisin/kexin type 9 synthesis inhibitor (PCSK9si).

FDA streamlines “compassionate use” application process

6th June 2016

The US Food and Drug Administration (FDA) has finalised its efforts to streamline the "compassionate use" process, used by physicians to access investigational drugs and biologics for patients with limited treatment options.

CE mark granted to Occlutech left atrial appendage occluder

2nd June 2016

Occlutech has obtained European CE mark approval for its left atrial appendage, (LAA), occluder. The device is a specifically designed implant for the minimally invasive closure of the LAA, a procedure that minimises the risk of strokes in patients suffering from atrial fibrillation.

Lack of an on-site cardiac surgery department should not be a barrier to TAVI

2nd June 2016

Holger Eggebrecht and others report in the European Heart Journal that the lack of an on-site cardiac surgery department should not be a contraindication to centres performing TAVI

Metallic bioresorbable scaffold “can be considered as an alternative” to polymeric scaffolds

1st June 2016

Michael Haude (Medical Clinic I, Städtische Kliniken Neuss, Neuss, Germany) and ...

BioVentrix receives FDA investigative device exemption for ALIVE trial of Revivent

1st June 2016

BioVentrix has received US Food and Drug Administration (FDA) investigational device exemption approval to initiate its pivotal ALIVE (American Less Invasive Ventricular Enhancement) clinical trial.

Philips Minicare I-20 handheld devices receives CE mark

1st June 2016

Royal Philips has received CE marking for its cardiac troponin I (cTnI) blood test with the Minicare I-20 handheld device. Minicare cTnI is designed to deliver lab-comparable test results in less than 10 minutes.

TAVI with Sapien 3 may be better than surgery for intermediate-risk patients

31st May 2016

A ccording to Vinod H Thourani (Emory University School of Me...

More data in support of newer generation stents for high bleeding risk patients

31st May 2016

Sara Ariotti, Marco Valgimigli and others report in JACC: Cardiovascular Interventions that a zotarolimus-eluting stent provides superior safety and efficacy compared with a bare metal stent in patients at high risk of bleeding. They talk to Cardiovascular News about the implications of these findings for the future use of bare metal stents.

Trial shows Orsiro is non-inferior to Resolute Integrity

31st May 2016

According to data presented at EuroPCR (17-20 May, Paris, France), a hybrid sirolimus-eluting stent (Orsiro, Biotronik) is non-inferior to a zotarolimus-eluting (Resolute Intergrity, Medtronic).

European Union agrees new rules for approving medical devices and in vitro diagnostic medical devices

31st May 2016

The Netherlands presidency of the European Council and representatives of the European Parliament have reached a political agreement on two draft regulations for medical devices. The new regulations are aimed at ensuring that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner.

New procedure uses heart rate to estimate life expectancy of infarct patients

27th May 2016

The heart rate may be an indicator of a person's life expectancy. A research team at the Technical University of Munich (Munich, Germany) has to this end analysed an effect which at first seems paradoxical: Minor irregularities in the heartbeat are indicative of a healthy body.

Polymer-free coronary stent more effective and safer than bare metal stent in ACS patients

27th May 2016

Patients with acute coronary syndromes (ACS) who are at high risk for bleeding have significantly lower rates of target lesion revascularisation and fewer adverse events after undergoing percutaneous coronary intervention (PCI) with a polymer-free biolimus-A (BA9) drug-coated stent than with those receiving a bare metal stent in results from a sub-study of the LEADERS FREE trial reported for the first time in a late-breaker session at EuroPCR 2016.

Pooled trial results show positive outcomes for Keystone Heart’s TriGuard

24th May 2016

Keystone Heart has announced that a pooled analysis of three prospective and comparable clinical studies of patients undergoing transcatheter valve implantation (TAVR) in USA and Europe, have shown that TriGuard cerebral protection significantly reduces stroke rate, lowers CNS infarction and reduces total lesion volume, without adversely impacting the safety of the TAVR procedure.

ResMed announces primary results for CAT-HF sleep apnoea trial

24th May 2016

ResMed has announced primary results from a multicentre, randomised controlled phase II trial-CAT-HF-presented at the European Society of Cardiology's 2016 Annual Heart Failure Congress.

Mitralign raises almost US$40 million in equity financing

24th May 2016

Mitralign has raised US$39.8 million to date in a Series E equity round of financing. With the Series E financing raised, the company plans to pursue US and CE regulatory approval for the commercialisation of their Trialign system, in parallel with preparations for European commercial launch of their Mitralign percutaneous annuloplasty system.

Medinol announces results for NIREUS trial of BioNIR stent

24th May 2016

Medinol has announced that the BioNIR has met its non-inferiority primary end point of angiographic in-stent late loss at six months in the NIREUS trial. The prospective, multicentre, randomised, non-inferiority pivotal study compared it to Medtronic's Resolute Integrity stent.

Jury favours CardiAQ in dispute with Neovasc

24th May 2016

A federal jury in Boston, USA, has returned a verdict in favour of Edward Lifesciences' CardiAQ in a lawsuit filed against a former service provider, Neovasc. The jury found that Neovasc breached the non-disclosure agreement between the parties, misappropriated CardiAQ's trade secrets, and breached its duty of honest performance to CardiAQ.

Direct Flow Medical reports DISCOVER trial three-year results

24th May 2016

Direct Flow Medical presented three-year results from its prospective, multicentre DISCOVER Trial at the 2016 EuroPCR meeting in Paris.

Alvimedica TNT session presented at EuroPCR

23rd May 2016

A session, sponsored by Alvimedica Medical Technologies, discussing treatment options for PCI in diabetic patients, took place at EuroPCR (16-20th May 2016, Paris, France).

HeartFlow haemodynamic data may help predict coronary plaque rupture potential

23rd May 2016

First-in-human data presented at EuroPCR 2016 have demonstrated that haemodynamic data from HeartFlow may help predict which coronary plaques have the potential to rupture.

Three-month data for Watchman show high success rate

19th May 2016

New data from the EWOLUTION registry, presented at EuroPCR 2016, confirms safety of the Boston Scientific left atrial appendage closure system (Watchman). The data are from more than 1,000 patients, from across Europe, who received the device and focus on post-procedural drug regimen, impact of centre experience and peri-device leakage.

Post-market study show “excellent” outcomes for Lotus TAVI valve

19th May 2016

According to results of the RESPOND post-market study, the Lotus TAVI device is associated with-a press release reports-excellent safety and efficacy outcomes at 30 days post implantation.

Drug-coated balloon is viable alternative to drug-eluting stent

19th May 2016

Results from the BIOLUX randomised control trial, which were presented at EuroPCR 2016, indicate that the Pantera Lux drug-coated balloon (Biotronik) is angiographically non-inferior to stenting with the latest-generation drug-eluting stents at six months for the treatment of in-stent restenosis.

iVascular completes recruitment of patients for ANCHOR clinical trial of Angiolite

19th May 2016

Recruitment of patients for iVascular's ANCHOR clinical trial has been completed with 104 patients treated with the sirolimus eluting stent Angiolite. The first interim three-month data have been presented at EuroPCR Congress 2016.

Study suggests major clinical benefit for left atrial appendage occlusion

19th May 2016

St Jude Medical has announced results from two cardiovascular clinical trials presented at EuroPCR 2016. The studies, which look at how St Jude Medical's fractional flow reserve (FFR) technology impacts patient outcomes in acute coronary syndrome and a comparison of left atrial appendage occlusion (LAAO) therapy to standard medical treatment, were presented during hotline sessions.

Corona Regional Medical Center installs Toshiba’s Vantage Titan and Aquilon Prime systems

19th May 2016

Corona Regional Medical Center (Corona, USA) has installed Toshiba's Vantage Titan 1.5 Tesla magnetic resonance imaging system. It has also chosen to feature the Aquilion Prime 160 and Aquilion Prime 40 computed tomography machines, also from Toshiba.

One-year paediatric feasibility study results published for Xeltis bioabsorbable graft

19th May 2016

One-year follow-up results from a paediatric feasibility study of Xeltis bioabsorbable cardiovascular pulmonary graft have been presented as late-breaker at the 96th American Association for Thoracic Surgery annual meeting.

St Jude Medical launches new Trifecta GT tissue valve in the USA

19th May 2016

St Jude Medical has launched the Trifecta valve with Glide Technology (GT) in the USA. The valve is designed for the treatment of patients diagnosed with unhealthy, damaged or malfunctioning aortic heart valves. It is intended to allow for an enhanced valve delivery method to ease implantation in challenging anatomies and during minimally invasive surgical approaches.

Major new study to investigate abbreviated DAPT in high bleeding risk patients

18th May 2016

At EuroPCR (17-20 May, Paris, France), a new global study that involves 4,300 patients from 34 countries was announced. The study, according to a press release, is set to shed light into the use of short duration DAPT in patients following stenting procedures, with a particular focus on those with a high bleeding risk.

St Jude Medical launches PressureWire X Guidewire in Europe

18th May 2016

St Jude Medical has announced CE mark approval and European launch of the PressureWire X Guidewire fractional flow reserve (FFR) Measurement System. Designed to identify the severity of narrowings in the coronary arteries of patients with coronary artery disease (CAD), FFR measurement allows for a more effective assessment of coronary lesions (blockages), resulting in more accurate diagnosis.

Sapien 3 demonstrates positive patient outcomes at 30 days in European real-world experience

18th May 2016

Edwards Lifesciences has announced that 30-day data from its European post-approval study of the Sapien 3 transcatheter aortic heart valve demonstrated positive patient outcomes, including the lowest reported mortality and stroke rates seen in the SOURCE family of registries.

Edwards’ surgical heart valve innovations demonstrate positive patient benefits

18th May 2016

Edwards Lifesciences has announced positive clinical trial results on two of its advanced innovations in surgical heart valves for the treatment of people with aortic valve disease. Data from three studies-COMMENCE, TRANSFORM and FOUNDATION-were presented as part of the late-breaking sessions at the American Association for Thoracic Surgery's (AATS) 96th annual meeting.

Corvia Medical InterAtrial shunt device receives CE mark

12th May 2016

Corvia Medical has been granted CE mark approval for its InterAtrial shunt device (IASD). The IASD is a transcatheter device designed to treat heart failure with preserved ejection fraction (HFpEF), previously called diastolic heart failure.