Tag: peripheral arterial disease

Infinity angioplasty balloon catheter completes first-in-human clinical trial

The Infinity Angioplasty Balloon Company announced today that its angioplasty balloon platform—the Infinity angioplasty balloon catheter—has successfully completed a first-in-human clinical trial. The platform was...

Latest VOYAGER PAD analysis finds no mortality and improved limb outcomes...

Given the absence of a safety signal in data from the VOYAGER PAD trial, a new analysis examined the potential benefit of drug-coated device...
Dabra

Ra Medical Systems announces 10 subjects have been enrolled in its...

Ra Medical Systems has announced enrolment of the tenth subject in its pivotal clinical trial to evaluate the safety and effectiveness of the Dabra...
Biotronik

CIRSE 2020: New clinical data support use of 4F devices for...

Outcomes of the BIO4AMB trial demonstrated that ambulatory treatment with 4­-French (4F) devices is a valid and safe option for endovascular treatment of lower...

First patient enrolled in FUTURE SFA study of MagicTouch sirolimus-coated balloon

Concept Medical has announced the enrolment of the first patient in the FUTURE SFA (Randomised controlled trial of first sirolimus coated balloon versus standard...

CMS grants additional reimbursement for the Eluvia drug-eluting vascular stent system

Boston Scientific announced that the US Centers for Medicare and Medicaid Services (CMS) granted a new technology add-on payment (NTAP) for the Eluvia drug-eluting...
PQ Bypass Detour

PQ Bypass receives FDA breakthrough device designation for the Detour system

PQ Bypass has announced that they received breakthrough device designation from the US Food and Drug Administration (FDA) for the Detour system. The Detour...

Philips to expand its image-guided therapy portfolio through acquisition of Intact...

Royal Philips today announced that it has signed an agreement to acquire Intact Vascular. According to a press release, Intact Vascular will enhance Philips’...

High level of heterogeneity found in randomised PAD trial antithrombotic regimens

A recent systematic review showed that randomised trials comparing different types of peripheral endovascular arterial intervention have a high level of heterogeneity in their...
Angiodynamics

First patient enrolled in PATHFINDER I registry examining Auryon atherectomy system

AngioDynamics has announced the enrolment of the first patient in the PATHFINDER I postmarket registry. The PATHFINDER I registry is a pilot study to evaluate...
PRIZER

PRIZER, new multicentre PAD study, launches

A new post-market study investigating the effectiveness of the Renzan peripheral stent system (Terumo) in patients with peripheral arterial disease (PAD) has been initiated....

iVascular launches Sergeant peripheral support catheter

iVascular recently announced the launch of its Sergeant peripheral support catheter. Sergeant is a CE marked over-the-wire catheter, indicated for patients with peripheral arterial...

MHRA: Warning to be added to paclitaxel device IFUs in Europe

In a new field safety notice, the UK Medicines and Healthcare products Regulatory Agency (MHRA) states that a warning and clinical summary section will...

CX 2020 LIVE: Strong support for relining peripheral arteries and rivaroxaban use for widespread atherosclerosis 

In a series of Podium 1st presentations from world-class faculty, CX 2020 LIVE attendees heard the latest data on peripheral arterial disease management and an evaluation of different types of stents, including...
Wingman catheter by Reflow Medical

Wingman catheter granted expanded indication to cross CTOs in PAD

Reflow Medical has announced that they have received US Food and Drug Administration (FDA) clearance for an expanded indication for the Wingman crossing catheter...
Torus stent graft (PQ Bypass)

CMS approves coverage for PQ Bypass TORUS 2 IDE trial

PQ Bypass announced today that it has received approval for coverage from the Centers for Medicare and Medicaid Services (CMS) for the Investigational Device...
Xarelto

Positive NICE recommendation for Xarelto to prevent atherothrombotic events in CAD...

The National Institute for Health and Care Excellence (NICE) has published the final appraisal determination (FAD) recommending the use of Xarelto (rivaroxaban) by the...

LimFlow receives FDA approval for US study of minimally-invasive technology designed...

LimFlow has announced that the US Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) for the PROMISE II pivotal study of...

New Cook Medical paclitaxel data confirm safety of Zilver PTX

New data on the use of Zilver PTX, Cook Medical’s paclitaxel-coated stent for peripheral arterial disease (PAD), confirms the safety of the device. These...
Interventional News for specialists

Cardiovascular Systems announces first patient enrolled in REACH PVI clinical study

Cardiovascular Systems recently announced that the first patient has been enrolled in the REACH PVI study. The purpose of this study is to prospectively...

New study points to SFDI as promising technology for assessing patients...

New evidence supports the utility of spatial frequency domain imaging (SFDI) for identifying compromised circulation in patients at risk of peripheral arterial disease (PAD)....
depression

Depression and peripheral arterial disease: A call to action

With “an indisputable association between depression and peripheral arterial disease (PAD)”—nearly a third of PAD patients experience comorbid depression or depressive symptoms—Joel Ramirez and...
cigarette

Smoking cigarettes associated with increased risk of peripheral arterial disease in...

African Americans who smoke cigarettes are more likely than those who do not smoke to develop peripheral arterial disease (PAD), according to new research...
Interventional News for specialists

Tack Endovascular System launches in the EU with first commercial use...

The first commercial use of the Tack Endovascular System (Intact Vascular) has taken place in multiple hospitals within Germany. A novel therapy for dissection...

PCSK9 inhibitors, rivaroxaban and a diabetes drug are major milestones in...

Michael Jaff (Newton, USA) outlines the major recent developments in best medical therapy that will impact the treatment of peripheral arterial disease (PAD) at...

Enrolment complete in T.I.N.T.I.N. study

iVascular has announced the completion of enrolment of patients in its T.I.N.T.I.N. (Treatment with the Luminor DCB and the iVolution self-expanding stent) study. The effectiveness...

First European patients treated with Peripheral Orbital atherectomy system

The first patients in Germany have been treated with its Stealth 360 Peripheral Orbital Atherectomy System (OAS; Cardiovascular Systems Inc). The German cases represent...
Interventional News for specialists

Enrolment begins in new atherosclerotic lesions study in the superficial femoral...

The first peripheral arterial disease (PAD) patient with disease in the superficial femoral and popliteal arteries has been successfully enrolled in the FORTEZ study....

First US patient enrolled in ILLUMENATE BTK study of Stellarex 0.014...

The first US patient has been enrolled in the Stellarex ILLUMENATE below-the-knee (BTK) investigational device exemption (IDE) study, led by principal investigators Bill Gray...
stellarex

Similar patency outcomes in women and men treated with Stellarex DCB

A study presented at VIVA 2018 (5–8 November, Las Vegas, USA) by Maureen Kohi, associate professor of Clinical Radiology, University of California, San Francisco,...
Surmodics logo

12-Month data from PREVEIL study of SurVeil DCB presented at VIVA

Data from the PREVEIL early feasibility study of the SurVeil drug-coated balloon (DCB, Surmodics) were shared in a late-breaking clinical trial presentation at the...

TOBA II trial meets primary and secondary endpoints at one-year

The Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial has successfully achieved both primary and secondary endpoints. One year results from the TOBA...

New Zilver PTX global data finds 76% freedom from TLR at...

Results from an aggregated data analysis of the use of the Zilver PTX drug-eluting peripheral stent (DES; Cook Medical) in challenging patient populations concluded...

IN.PACT SFA Trial five-year data and Total IN.PACT All-Subjects analysis presented...

  The five-year and final results from the pivotal IN.PACT SFA Trial and one-year all-subjects results from the Total IN.PACT Pooled Analysis of the IN.PACT...

Positive outcomes for Eluvia stent in long lesion IMPERIAL sub-study

Clinical outcomes from the IMPERIAL Long Lesion Sub-study were presented at VIVA (5–8 November, Las Vegas, USA) demonstrating that the Eluvia drug-eluting vascular stent...

Five-year evaluation of Zilver PTX stent in a real-world population continues...

Five-year results from a Japanese post-market surveillance study aimed at evaluating the Zilver PTX drug-eluting stent (DES) in a real-world population show consistently positive...

Bayer announces new licensed indication for use of Xarelto in patients...

Xarelto, co-administered with aspirin, is indicated in the EU for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or...

LIBERTY 360° two-year data show high freedom from major amputation in...

Two-year outcomes from the LIBERTY 360° study have shown a marked improvement across all Rutherford classes, as well as high freedom from major amputation....

Ra Medical files statement for proposed initial public offering

Ra Medical Systems has filed a registration statement on Form S-1 with the US Securities and Exchange Commission relating to a proposed initial public...
Purple drug-coated balloon in an s shape

Medtronic receives US FDA clearance for 200mm and 250mm IN.PACT Admiral...

Medtronic has announced that it has received US FDA approval for 200mm and 250mm lengths of the IN.PACT Admiral drug-coated balloon (DCB) to treat...

First US implants of MicroStent for peripheral arterial disease take place

MicroStent (Micro Medical Solutions), a vascular stent designed to reduce below-the-knee amputations caused by critical limb ischaemia (CLI) resulting from peripheral arterial disease (PAD)...

US FDA clears CorPath GRX system for use in peripheral vascular...

Corindus has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) for use of the CorPath GRX system in peripheral vascular...

LINC 2018 data highlight IN.PACT Admiral as safe and effective treatment...

Medtronic added to its robust body of clinical evidence supporting the IN.PACT Admiral drug-coated balloon with new presentations that demonstrated durable and consistent clinical...

More than one in six patients with PAD who undergo revascularisation...

A study of nearly 62,000 hospitalisations nationwide in the USA has found that more than one in six patients with peripheral arterial disease (PAD)...

Interrupting inflammatory signals decreases repeat artery blockage in peripheral arterial disease...

Peripheral artery disease patients who were treated with an anti-inflammatory steroid injected directly into the tissue surrounding their leg artery showed a significant reduction...

Barry Katzen announces new global society for critical limb ischaemia

Barry Katzen, Miami, USA, announced the establishment of a new society, the Critical Limb Ischaemia (CLI) Global Society, whose mission is to improve quality...

Gore Tigris vascular stent gains FDA approval for treatment of peripheral...

Gore has announced US Food and Drug Administration (FDA) approval of the Gore Tigris vascular stent, a dual-component stent with a unique fluoropolymer/nitinol design....